http://www.daiichisankyo-jobs.com/feeds/clinical-data-manager-New-Jersey-jobs/ Custom RSS Feed for clinical-data-manager-New-Jersey-jobs Wed, 08 Sep 2010 23:09:03 GMT en-us /sites/daiichisankyo/images/ds_header1.jpg http://www.daiichisankyo-jobs.com/feeds/clinical-data-manager-New-Jersey-jobs/ 720 Job Title Associate Director Clinical Pharmacology
Functional Area Research & Development
City Edison
State New Jersey
Job Description
Job Summary:

We are currently seeking a Associate Director, Clinical Pharmacology for our Edison, New Jersey location. This position will develop and direct the clinical pharmacology studies for a product(s) within Daiichi Sankyo Pharma Development; assist in preparing clinical pharmacology sections of Investigator Brochures, CTD and other regulatory submissions; and draft and/or review abstracts and manuscripts based on clinical study data and modeling and simulation reports for a drug in late stage development

Responsibilities:

In this role, you will support the clinical pharmacology aspects of a compound in late development; represent translational medicine and clinical pharmacology for integration of clinical pharmacology sections with other departments; prepare clinical pharmacology sections of regulatory documents and CTD, external presentations and publications; and draft and/or review abstracts and manuscripts based on clinical study and modeling and simulation reports for a drug in late stage development.

You will also develop clinical pharmacology plans, design and direct clinical pharmacology studies; work with Study Logistics, CROs and other vendors to execute clinical pharmacology studies and if medically qualified, also responsible for medical review of additional TM/CP projects, including assessment of subject risk/benefit. Additionally, you will participate in the management of Contract Research Organizations (CROs) in the conduct of clinical pharmacology studies and the analysis and reporting of clinical pharmacokinetic and pharmacodynamic data. Management of clinical pharmacology study report production and review of primary data tables, interpretation of results, supervise final review and approval.

Education/Experience

Qualified candidates must have a M.D. with post graduate training in clinical pharmacology or Ph.D. in Pharmaceutics or PharmD with clinical post graduate training and a minimum of 3 years of clinical pharmacology and pharmacokinetics experience, including development of clinical pharmacology programs for new chemical entities and directing clinical pharmacology studies. Previous experience with preparation of CTD preferred.

Excellent writing ability, organizational, communication and interpersonal skills, as well as effective collaboration and negotiation techniques. Must be able to work cross-functionally, independently and to effectively prioritize, proactively identify and resolve problems and work in a team environment.

Highly proficient in standard computer software (Word, Excel and Power Point) and helpful to have proficiency in specialized software for pharmacokinetic data analysis such as NONMEM, S-Plus, ADAPT or other.

Knowledge of pharmacokinetic and pharmacodynamic principles. Knowledge of clinical pharmacology, specifically a strong background in ADME principles, model based drug development paradigm, pharmacometric methods, bioanalysis principles and statistical methods

Familiarity with the preparation of regulatory submissions to various Regulatory Authorities (FDA and EMEA).

Must be willing to travel 10% of the time.]]> Mon, 30 Aug 2010 00:08:00 http://www.daiichisankyo-jobs.com/job/Edison-Senior-Scientist-Clinical-Pharmacology-Job-NJ-08817/816972/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS http://www.daiichisankyo-jobs.com/job/Edison-Senior-Scientist-Clinical-Pharmacology-Job-NJ-08817/816972/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Job Title Project Data Manager
Functional Area Medical Affairs
City Parsippany
State New Jersey
Job Description
Job Summary:

We are currently seeking an Project Data Manager in our Medical Affairs team for our Parsippany, New Jersey location. This position will be responsible for the planning, organization and coordination of data management activities in a project; ensure overall database consistency across all studies within a project; manage all activities centered around CRF design, data collection, data retrieval, global integrated database development, coding, and query management for PoC to Phase 4 clinical trials; oversee, monitor, and evaluate all interactions with external vendors (CROs); and ensure data management standards and quality are maintained and implemented.

Responsibilities:

In this role, you will be the primary contact for all project teams to ensure data quality and oversee the timely delivery of all department project related data management activities consistent with time lines including but not limited to, CRF design, data collection, edit checks, consistency of data collected across investigative sites, query management, data quality control, medical coding, SAE reconciliation between clinical trial and drug safety databases, quality audits of the database against data collection instrument sources, database locks, and archival of Data Management deliverables and documents.

Education/Experience

Qualified candidates must have a Bachelor's degree or Registered Nurse with a minimum of 6 years pharmaceutical/data management experience or a Master's degree plus a minimum of 4 years experience in pharmaceutical/data management. Project management experience is preferred. Clinical database administration and system validation experience; CRO management experience; and demonstrated knowledge of clinical data flow and research design are critical skills in this role.]]> Sun, 05 Sep 2010 00:09:00 http://www.daiichisankyo-jobs.com/job/PARSIPPANY-Project-Data-Manager-Job-NJ-07054/796847/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS http://www.daiichisankyo-jobs.com/job/PARSIPPANY-Project-Data-Manager-Job-NJ-07054/796847/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Job Title Project Data Manager
Functional Area Research & Development
City Edison
State New Jersey
Job Description
Job Summary:

We are currently seeking a Project Data Manager for our Edison, New Jersey location. This position is responsible for the global planning, organization, and coordination of data management activities in a project; ensures overall database consistency across all studies within a project; manages all activities centered around CRF design, data collection, data retrieval, global integrated database development, coding, and query management for PoC to Phase 4 clinical trials; oversees, monitors, and evaluates all interactions with external vendors (CROs); and ensures data management standards and quality are maintained and implemented.

Responsibilities:

In this role, you will Oversees all project related Data Management activities at Daiichi-Sankyo, including but not limited to, CRF design, data collection, edit checks, consistency of data collected across investigative sites, query management, data quality control, medical coding, SAE reconciliation between clinical trial and drug safety databases, quality audits of the database against data collection instrument sources, database locks, and archival of Data Management deliverables and documents

Primary contact for all project teams, domestic and global, to ensure data quality and timely database delivery. Reviews Data Management performance against established metrics in a Data Management Performance Report, prepared at the conclusion of each study. Ensures that a complete archive of Data Management documents and records is maintained at the Daiichi-Sankyo site in accordance with applicable Daiichi-Sankyo and regulatory guidelines. Evaluates contracted regional CROs on an ongoing basis to determine if they fulfill Requirements of SOPs (including Working Policies (WPs)), timeliness, and quality.

Evaluates candidate CROs and external vendors as to their ability to adhere to Daiichi-Sankyo SOPs (including WPs), and quality standards before any outsourcing contract is finalized. Manages database and supporting documentation archival to meet long-term regulatory requirements. Demonstrates Daiichi-Sankyo core competencies at the management level; exhibits Daiichi-Sankyo values. Ensures that all project related outsourcing agreements are comprehensive and complete.

Education/Experience

Qualified canddiates must have a Master's degree; Bachelors degree or registered nurse in life sciences; 4 to 6 years (MS) pharmaceutical/data management; 6 to 8 years (BS/RN) pharmaceutical/data management. Project management experience is preferred. Demonstrated knowledge of clinical data flow and research design; clinical database administration and system validation experience; demonstrated competence with GCP/regional regulatory guidelines, SOPs (including WPs), medical terminology, standard coding dictionaries, and demonstrated proficiency in applying them to all relevant therapeutic areas and CRO management experience, including a thorough knowledge of CRO audits are critical skills in this role. EDC and SDTM experience is preferred.]]> Sun, 29 Aug 2010 00:08:00 http://www.daiichisankyo-jobs.com/job/Edison-Project-Data-Manager-Job-NJ-08817/816015/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS http://www.daiichisankyo-jobs.com/job/Edison-Project-Data-Manager-Job-NJ-08817/816015/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Job Title Clinical Study Manager
Functional Area Research & Development
City Edison
State New Jersey
Job Description
Job Summary:

We are currently seeking a Clinical Study Manager for our Edison, New Jersey location. This position will be responsible for the overall management and implementation of global clinical research studies for the investigation of new drugs. Drug product candidates under investigation may belong to any therapeutic area. The incumbent will oversee performance and interactions with CROs and other external vendors. This individual will report directly to the Director/Assoc. Director Clinical Operations, and for project related activities, to the assigned Therapeutic Area Clinical Study Leader to ensure that clinical studies are conducted in a cost-effective manner according to the timelines, budget and objectives set forth by the Product Development Plan, and per Daiichi Sankyo procedures, FDA regulations/EU Directive and ICH GCP Guidelines.

Responsibilities:

In this role, you will develop study implementation plan. Participate in site selection and site qualification. Manage CRO performance and interface with CRO management for resolution of issues with implementation of clinical studies or resources. Ensure timely and cost-effective implementation of clinical trials. Manage GCP compliance issues and assure appropriate communication, issue resolution and adherence to SOPs and guidelines. Archive study material. Support preparation of Clinical Development Plans (CDPs), protocol profiles and clinical sections of NDAs. Manage completion of CRFs and other relevant study-related documents. Prepare drafts of entire Clinical Trial Protocols, Clinical Trial Reports and sections of Briefing Documents and INDs under the supervision of Clinical Study Director. Ascertain proper inclusion of appendices for study reports. Coordinate document review using appropriate tools. Assess signals in clinical database and propose monitoring strategies and pre-emptive solutions to CRO, Medical Monitor or Clinical Study Leader. Review and approve site contracts, informed consent forms, study budgets, work orders and invoices prior to final approval. Manage study drug coordination with CSO. Handle logistics for investigator meetings. Make presentations at management reviews, investigator and consultant meetings, as needed.

Education/Experience
Qualified candidates must have Bachelor?s Degree in Life Sciences or higher. A minimum of 3 years of experience in clinical research (at least 2 of these in Clinical Development) in pharmaceutical or device company, Academic Research Organization or CRO with BS. Minimum of 2 years of clinical research experience with MS, MPH, PhD or higher. Complete understanding of the concepts and applications of clinical research, medical terminology and other disciplines involved in drug development. Proficient skills in computer applications such as Word, Excel, and PowerPoint. Strong oral and written communication skills. Complete knowledge of GCP, FDA CFRs and ICH Guidelines. Ability to interpret data and to present results in a concise and clear manner. Management and leadership skills to contractors to the successful completion of the project. Working knowledge of the components and key content Requirements of IND & NDAs.]]> Tue, 17 Aug 2010 00:08:00 http://www.daiichisankyo-jobs.com/job/Edison-Clinical-Study-Manager-Job-NJ-08817/881780/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS http://www.daiichisankyo-jobs.com/job/Edison-Clinical-Study-Manager-Job-NJ-08817/881780/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Job Title Director, Modeling and Simulation
Functional Area Research & Development
City Edison
State New Jersey
Job Description
Job Summary:

We are currently seeking a Director, Modeling and Simulation for our Edison, New Jersey location. This position ensures state-of-the-art modeling and simulation is used during preclinical and clinical development to support product development and decision making

Responsibilities:

In this role, you will develop and implement modeling and simulation plans for compounds in development that contribute to dose selection, sample size power, sampling scheme, issue resolution and decision making in conjunction with Translational Medicine, Clinical Pharmacology and Clinical Development.

Conduct key model based analyses and interact with external partners to conduct these analyses.

Develop innovative study designs for translational medicine and clinical pharmacology studies.

Work with Bioinformatics on strategies to support translational medicine and clinical pharmacology activities.

Support model based predictions of human pharmacokinetics and pharmacodynamics based on preclinical data.

Education/Experience

Qualified candidates must have a Ph.D. in Pharmaceutical science or equivalent.

Minimum requirement 8 years clinical pharmacology and pharmacokinetics experience, including implementation of state of art modeling and simulation to support compound development. Expertise in M&S in support of cardiovascular, oncology and diabetics preferred.

In-depth knowledge of current regulatory Requirements (FDA, GCP and ICH).

Ability to work independently and to effectively prioritize, proactively identify and resolve problems and work in a team environment.

Must possess excellent communication and interpersonal skills, as well as effective collaboration and negotiation techniques.

Highly proficient in standard computer software (Word, Excel and Power Point) and helpful to have proficiency in specialized software for pharmacokinetic data analysis.

Demonstrated experience in population pharmacokinetic-pharmacodynamic modeling required using NONMEM. Experience in clinical trials simulation desirable.]]> Wed, 01 Sep 2010 00:09:00 http://www.daiichisankyo-jobs.com/job/Edison-Director,-Modeling-and-Simulation-Job-NJ-08817/866859/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS http://www.daiichisankyo-jobs.com/job/Edison-Director,-Modeling-and-Simulation-Job-NJ-08817/866859/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Job Title Director, Biostatistics and Data Management
Functional Area Medical Affairs
City Parsippany
State New Jersey
Job Description
Job Summary:

We are currently seeking a Director, Biostatistics and Data Management for our Parsippany, NJ location. This position assigns and directs biostatistical and data management resources for sponsored clinical research, and for investigator-initiated studies as needed; reviews documents for appropriateness of methods; and actively collaborates with colleagues in the Biostatistics and Data Operations department within our Development Division.

Responsibilities:

In this role, you will oversee all project related Data Management activities within DSAC including but not limited to CRF design, data collection, edit checks, consistency of data collection, query management, data quality control, medical coding, SAE reconciliation between clinical trial and drug safety databases, quality audits and evaluations of databases, database locks, and archival of Data Management deliverables and documents. Additionally, you will ensure that study design, protocol preparation, and statistical analysis methodologies meet study/project objectives, and are in compliance with regulatory guidances; lead Biostatistics and Data Management team for Medical Affairs, ensuring appropriate support for all Phase 3b and Phase 4 studies, as well as, data mining projects; and ensure accuracy of all completed statistical analyses and interpretation in clinical study reports; and adherence to timelines for accountable deliverables for all projects.

Education/Experience
Qualified candidates must have a MS in Statistics, Biostatistics, or Mathematics with a minimum of 15 years of pharmaceutical industry experience or a PhD in Statistics, Biostatistics, or Mathematics with a minimum of 10 years of pharmaceutical industry experience. Extensive experience analyzing clinical trial data; experience managing external contracted resources required; direct personnel management experience is preferred. The incumbent must have full knowledge of advanced statistical analytical methods, data management, clinical trial research, regulatory Requirements, programming skills, and statistical software. Demonstrated mastery of advanced statistical analytical methods, competency in SAS, clinical trial search, regulatory requirements; coding techniques, protocol development and personal computing.]]> Thu, 26 Aug 2010 00:08:00 http://www.daiichisankyo-jobs.com/job/Parsippany-Director,-Biostatistics-and-Data-Management-NJ-07054/917272/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS http://www.daiichisankyo-jobs.com/job/Parsippany-Director,-Biostatistics-and-Data-Management-NJ-07054/917272/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Job Title Sr. Director, Clinical Development, Oncology
Functional Area Research & Development
City Edison
State New Jersey
Job Description
Job Summary:

We are currently seeking a Senior Director, Clinical Development, Oncology for our Edison, New Jersey location. This position oversees and manages a regional development program or multiple multinational phase II/III clinical trials in order to achieve a high quality product for the marketplace and business success for Daiichi Sankyo; and will finalize clinical development plans, protocol profiles and sections of key submission documents. You will be the point of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters; and oversee management and performance of CROs ensuring high quality products.

Responsibilities:

In this role, you will prepare the Clinical Development Plan, budget and proposed go/no-go decision criteria for a regional development program ensuring the medical and commercial needs and the regulatory Requirements are met.

Oversees preparation of phase II/III clinical trial protocols and clinical trial reports ensuring adequate testing of the highest scientific, ethical and professional standards, appropriate risk management strategies and proper interpretation of the data.

Manage direct and indirect reports, external partners, consultants, vendors and external budget to ensure the timely and cost-effective implementation of a Regional Development Plan or multiple multinational phase II/III clinical trials.

Supervise and mentor direct and indirect reports, as necessary. Support assessment of CROs and preferred vendors for implementation of clinical development plan for global or regional clinical development programs. Review and approve contracts, work orders and invoices prior to submission to management for approval. Establishes and maintains effective communication and collaboration with functional area peers, including basic research, manufacturing, regulatory, quality assurance, project management, and marketing, as well as thought leaders in order to meet program objectives and support achievement of department and corporate goals. Provides input to non-clinical and commercial functions on medical needs and strategic issues for the therapeutic area.

Support assessment of in-licensing product candidates in area of expertise, as needed.

Education/Experience

Qualified candidates must have a MD and a minimum 5 years of pharmaceutical development experience and at least 3 years of hands-on experience managing a major, multi-country, clinical program. Must be an Oncologist.

Knowledge of pharmaceutical business, worldwide drug development and regulatory process. Expertise in complex clinical trial design (i.e. factorial design, etc.) and complex implementation (i.e. including Steering Committees, Safety Monitoring Boards, etc.) as well as the interpretation of scientific data. Independent thinking, creativity and innovation. Ability to deliver high quality products. Strong interpersonal skills and ability to interface effectively with multinational development teams in a multicultural working environment. Excellent communication, presentation and negotiation skills with emphasis on building consensus. Ability to effectively manage interactions with academic thought leaders ensuring optimal cooperation for achieving program and department goals. Ability to anticipate and facilitate issue resolution in a multicultural working and business environment.]]> Sun, 15 Aug 2010 00:08:00 http://www.daiichisankyo-jobs.com/job/Edison-Sr_-Director,-Clinical-Development,-Oncology-Job-NJ-08817/880012/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS http://www.daiichisankyo-jobs.com/job/Edison-Sr_-Director,-Clinical-Development,-Oncology-Job-NJ-08817/880012/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Job Title Associate Director, HEOR Biostatistics
Functional Area Medical Affairs
City Parsippany
State New Jersey
Job Description
Job Summary:

We are currently seeking a Assoc Dir HEOR Biostatistics, for our Parsippany, New Jersey location. This position serves as an analytical expert to the HEOR team and supports scientifically rigorous outcomes research and development of documents for external dissemination.

Responsibilities:

In this role, you will clean, program, and analyze claims data from Payer (Commercial and Govt.) and EMRs from Provider databases to conduct Observational Outcomes and Pharmacoepidemiological studies to support pipeline and marketed products; generate descriptive and inferential statistics and interpret results for the study reports and publications; and perform QA of the analyses results, troubleshooting gaps and anomalies. Additionally, you will work with HEOR therapeutic/product lead to develop study protocols and statistical analysis plans for economic and patient-reported outcomes endpoints in phase II, III and IV clinical studies; analyze HEOR data from clinical studies for inclusion in clinical study reports, value dossiers and publications; and provide input to the relevant sections of clinical study protocols to optimize study designs and data collection.

Education/Experience
Qualified candidates must have an advanced degree in biostatistics or relevant field and a minimum of 5 years experience in the pharmaceutical industry or consulting organization. Ph.D. is preferred. Analytical experience in cardiovascular and oncology; and knowledge of cardiovascular and oncology therapeutic areas is preferred. Proficiency in data management across multiple platforms; expertise in using statistical software such as SAS and SPSS; and scientific computer programming, database querying, and descriptive and inferential statistics are required. Experience with economic modeling, multiple imputation techniques and truncated data analysis is preferred. Must be willing to travel 10% of the time.]]> Sun, 15 Aug 2010 00:08:00 http://www.daiichisankyo-jobs.com/job/Parsippany-Associate-Director,-HEOR-Biostatistics-Job-NJ-07054/908898/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS http://www.daiichisankyo-jobs.com/job/Parsippany-Associate-Director,-HEOR-Biostatistics-Job-NJ-07054/908898/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Job Title Staff Biostatistician
Functional Area Research & Development
City Edison
State New Jersey
Job Description
Job Summary:

We are currently seeking a Staff Biostatistician for our Edison, New Jersey location. This position is responsible for providing statistical guidance on range of topics and regular project updates; acts as a statistical consultant in regulatory and clinical forums and meetings across all projects and programs; seeks out and tests new statistical software; and seeks to broaden the utilization and acceptance of departmental expertise and support in areas outside of Clinical Development and Regulatory Affairs.

Responsibilities:

In this role, you will collaborate globally to ensure worldwide acceptance of statistical design and analyses; and ensure accuracy of all statistical analyses and interpretation in clinical study reports and of timelines for deliverables within assigned projects. You will ensure that study design, protocol preparation, and statistical analysis methodologies meet study/project objectives, and are in compliance with regulatory guidances; and establish the consistency of study designs, parameter algorithms and definitions, analyses and calculations, and reporting formats for all studies within assigned project.

Education/Experience

Qualified candidates must have a MS or PhD in Statistics, Biostatistics, or Mathematics. PhD + 8 yrs or MS + 10 years of pharmaceutical industry experience; full knowledge of advanced statistical analytical methods, clinical trial research, regulatory Requirements, coding techniques, and statistical software.
Excellent oral and written communication skills; project planning skills; demonstrated experience in analyzing clinical trial data; priority setting skills; multi-tasking skills; problem solving skills; eye for detail; exercise good judgment; and works well within team framework. Comprehensive project management skills.Demonstrated competency in SAS. Regular attendance at IDT Meetings is necessary; experience in managing CROs and external vendors. Must be willing to travel 10% of the time.]]> Thu, 02 Sep 2010 00:09:00 http://www.daiichisankyo-jobs.com/job/Edison-Staff-Biostatistician-Job-NJ-08817/893073/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS http://www.daiichisankyo-jobs.com/job/Edison-Staff-Biostatistician-Job-NJ-08817/893073/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Job Title Clinical Study Manager
Functional Area Research & Development
City Edison
State New Jersey
Job Description Job Summary:
The incumbent will be responsible for the overall management and implementation of global clinical research studies for the investigation of new drugs. Drug product candidates under investigation may belong to any therapeutic area. The incumbent will oversee performance and interactions with CROs and other external vendors. This individual will report directly to the Director/Assoc. Director Clinical Operations, and for project related activities, to the assigned Therapeutic Area Clinical Study Leader to ensure that clinical studies are conducted in a cost-effective manner according to the timelines, budget and objectives set forth by the Product Development Plan, and per Daiichi Sankyo procedures, FDA regulations/EU Directive and ICH GCP Guidelines

Responsibilities:
Develop study implementation plan. Participate in site selection and site qualification. Manage CRO performance and interface with CRO management for resolution of issues with implementation of clinical studies or resources. Ensure timely and cost-effective implementation of clinical trials. Manage GCP compliance issues and assure appropriate communication, issue resolution and adherence to SOPs and guidelines. Archive study material. Support preparation of Clinical Development Plans (CDPs), protocol profiles and clinical sections of NDAs. Manage completion of CRFs and other relevant study-related documents. Prepare drafts of entire Clinical Trial Protocols, Clinical Trial Reports and sections of Briefing Documents and INDs under the supervision of Clinical Study Director. Ascertain proper inclusion of appendices for study reports. Coordinate document review using appropriate tools. Assess signals in clinical database and propose monitoring strategies and preemptive solutions to CRO, Medical Monitor or Clinical Study Leader. Review and approve site contracts, informed consent forms, study budgets, work orders and invoices prior to final approval. Manage study drug coordination with CSO. Handle logistics for investigator meetings. Make presentations at management reviews, investigator and consultant meetings, as needed.

Education/Experience
Bachelor's Degree in Life Sciences or higher. A minimum of 3 years of experience in clinical research (at least 2 of these in Clinical Development) in pharmaceutical or device company, Academic Research Organization or CRO with BS. Minimum of 2 years of clinical research experience with MS, MPH, PhD or higher. Complete understanding of the concepts and applications of clinical research, medical terminology and other disciplines involved in drug development. Proficient skills in computer applications such as Word, Excel, and PowerPoint. Strong oral and written communication skills. Complete knowledge of GCP, FDA CFRs and ICH Guidelines. Ability to interpret data and to present results in a concise and clear manner. Management and leadership skills to contractors to the successful completion of the project. Working knowledge of the components and key content Requirements of IND & NDAs.]]> Sun, 05 Sep 2010 00:09:00 http://www.daiichisankyo-jobs.com/job/EDISON-Clinical-Study-Manager-Job-NJ-08817/706725/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS http://www.daiichisankyo-jobs.com/job/EDISON-Clinical-Study-Manager-Job-NJ-08817/706725/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Job Title Director, Clinical Development
Functional Area Research & Development
City Edison
State New Jersey
Job Description
Job Summary:

We are currently seeking a Director, Clinical Development, for our Edison, New Jersey location. This position oversees and manages regional and global phase II/III clinical trials and clinical development programs to deliver top notch clinical results leading to successful product registration and novel medicine. In this position, you will also prepare clinical development plans, protocol profiles and sections of key submission documents, be the point of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters for the assigned projects, and oversee management and performance of CROs to ensure high quality products.

Responsibilities:

In this role, you will

prepare Clinical Development Plan, budget and proposed go/no-go decision criteria for a regional development program ensuring the medical and commercial needs and the regulatory Requirements are met.

Oversee preparation of clinical trial protocols and clinical trial reports ensuring adequate testing of the highest scientific, ethical and professional standards, appropriate risk management strategies and proper interpretation of the data.

Manage matrix reports, external partners, consultants, vendors and external budget to ensure the timely and cost-effective implementation of a assigned programs and clinical trials. Support assessment of CROs and preferred vendors for implementation of clinical development plan for global or regional clinical trials. Review and approve contracts, work orders and invoices prior to submission to management for approval.

Establishes and maintains effective communication and collaboration with functional area peers, including basic research, manufacturing, regulatory, quality assurance, project management, and marketing, as well as thought leaders in order to meet program objectives and support achievement of department and corporate goals.

Provides input to non-clinical and commercial functions on medical needs and strategic issues for the therapeutic area. Assess and interpret preclinical data and plan clinical development based on pre-clinical results.

Support assessment of in-licensing product candidates in area of expertise, as needed.

Education/Experience

Qualified candidates must have a MD with training in Internal Medicine. Subspecialty training in Endocrine and Metabolism or related therapeutic area preferred. PhD or PharmD degree candidates with extensive clinical development experience will be considered.

For MD, a minimum 2 years of hands-on industry experience in drug and clinical development is required. For PhD or Pharm. D, a minimum of 4 years of clinical development is required. Knowledge of pharmaceutical business, worldwide drug development and regulatory process are preferred. Expertise in complex clinical trial design (i.e. factorial design, etc.) and complex implementation (i.e. including Steering Committees, Safety Monitoring Boards, etc.) as well as the interpretation of scientific data.

Independent thinking, creativity, self starting and innovation. Ability to deliver high quality products. Strong interpersonal skills and ability to interface effectively with multinational development teams in a multicultural working environment. Excellent communication, presentation and negotiation skills with emphasis on building consensus. Ability to effectively manage interactions with academic thought leaders ensuring optimal cooperation for achieving program and department goals. Ability to anticipate and facilitate issue resolution in a multicultural working and business environment.]]> Wed, 25 Aug 2010 00:08:00 http://www.daiichisankyo-jobs.com/job/Edison-Director,-Clinical-Development-Job-NJ-08817/887515/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS http://www.daiichisankyo-jobs.com/job/Edison-Director,-Clinical-Development-Job-NJ-08817/887515/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Job Title Sr. Director, Pharmacoepidemiology and Outcomes Research
Functional Area Medical Affairs
City Parsippany
State New Jersey
Job Description
Job Summary:

We are currently seeking a Senior Director, Pharmacoepidemiology & Outcomes Research, for our Parsippany, New Jersey location. This position serves as an in-house technical expert for HEOR team on all pharmacoepidemiology, biostatistics and publication issues to drive scientific rigor in prospective and retrospective study designs, publications and external communications; and builds and leads a group of biostatisticians and publication personnel with expertise in health economic and outcomes research methods.

Responsibilities:

In this role, you will lead and conduct pharmacoepidemiological and outcomes studies (phases I ? IV) utilizing large payer and provider databases, systematic literature review/synthesis techniques, psychometric evaluation to generate high quality scientific evidence to inform prospective and retrospective outcomes study designs and endpoints leading to strong value proposition for external stakeholders; conceptualize HEOR study protocols, oversee statistical analysis plans, development of study reports, abstracts, posters, manuscripts and value dossiers; and partner with highly experienced HEOR therapeutic/project leads to develop pharmacoepidemiological knowledge base to support DS pipeline and marketed products, oversee analyses of HEOR data from phases II ? IV clinical studies and post-hoc analyses of the clinical study data from external customers' perspective.

Education/Experience
Qualified candidates must have a Ph.D. in Epidemiology (or related field) or M.D. with advanced training in Epidemiology and a minimum of 8 years of experience in overseeing/conducting pharmacoepidemiological research in the pharmaceutical industry or a consulting organization. Experience in cardiovascular and oncology pharmacoepidemiological & outcomes research is preferred. Proficiency in scientific literature synthesis and clinical/retrospective database management and analyses utilizing inferential biostatistics (multiple regression, ANOVA, survival analysis, etc); and designing and applying appropriate multivariate statistical techniques in pharmacoepidemiological and health economics & outcomes research projects. Must be willing to travel 10% of the time.]]> Thu, 02 Sep 2010 00:09:00 http://www.daiichisankyo-jobs.com/job/Parsippany-Sr_-Director,-Pharmacoepidemiology-and-Outcomes-Research-Job-NJ-07054/842218/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS http://www.daiichisankyo-jobs.com/job/Parsippany-Sr_-Director,-Pharmacoepidemiology-and-Outcomes-Research-Job-NJ-07054/842218/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Job Title Sr Scientist Clinical Pharmacogenomics
Functional Area Research & Development
City Edison
State New Jersey
Job Description
Job Summary:

This position provides support for all pharmacogenomic assessments for selected compounds in all stages of clinical drug development; will become engaged in planning pharmacogenomic assessments in the translational stage (?bench to bedside?) and apply them early in the clinical development studies through to the clinical PoC phase. In Phase 2/3 clinical trials, the Sr Scientist, Clinical pharmacogenomics will also support incorporation of those pharmacogenomic endpoints that have potential to add value to the assessment of clinical outcomes and help streamline the approval process of compound.

This position will also contribute to the design, conduct, and analysis of selected Daiichi Sankyo studies with pharmacogenomic assessments; manage external vendors and consultants related to Pharmacogenomics; and lead TMCP studies and serve as a functional representative on local and global development teams and initiative teams.

Responsibilities:

In this role, you will In conjunction with members of the Translational Medicine departments in US and Japan, DMPKRL, and the project teams, support creation and implementation of compound-specific pharmacogenomic strategies for clinical trials with selected Daiichi Sankyo compounds, the timely delivery to the project team of pharmacogenomic results, and the interpretation of such results. Primary responsibility for establishing key criteria for decision making on projects based on pharmacogenomic endpoints.

You will also represent TMCP on project team and direct clinical pharmacology studies. This includes overseeing protocol writing, clinical conduct, data analysis / interpretation and report generation for TMCP studies; collaborate with supporting functions such as Study Logistics, Data Management and Biostatistics to ensure timely data base lock, analysis and reporting within the project timelines; ensure timely and accurate feedback to preclinical research on pharmacogenomic results from clinical studies (?bedside to bench?); develop budget estimates for clinical pharmacogenomic activities; and support the resolution of ethical, legal and social issues around human pharmacogenomic samples. Additionally, you will contribute to the development of standardized working practices for worldwide use in collection, shipment and storage of pharmacogenomic samples across all projects; ensure appropriate handling of pharmacogenomic samples to ensure the integrity of subsequent pharmacogenomic data; support the selection of externally supported platform based tools that will optimize the assessment of clinical pharmacogenomic endpoints; and oversee identification of external providers of pharmacogenomic services from academia and the commercial sector.

Education/Experience

Qualified candidates must have MD, PharmD, or PhD in Life Sciences.

Minimum requirement 0-5 years; Background of academic or pharmaceutical industry research experience, with a role having responsibility for pharmacogenomic strategies in clinical research projects. Experience leading clinical research studies is very desirable. Post-doctoral training/experience is also very desirable.

Proven strong science background as evidenced by a good publication record. Ability to work with minimal supervision to identify, prioritize and resolve problems. Ability to work effectively in a team environment. Strategic orientation with evidence of implementation and oversight of clinical pharmacogenomic plans and/or studies.

Familiarity with ICH, FDA and GCP guidelines to effectively provide guidance around clinical trial design and the medical, ethical, legal and social issues concerning pharmacogenomics. Ability to collaborate with interdisciplinary functions within and outside Daiichi Sankyo to implement novel pharmacogenomic research activities.

Must be willing to travel 10% of time.]]> Wed, 18 Aug 2010 00:08:00 http://www.daiichisankyo-jobs.com/job/Edison-Sr-Scientist-Clinical-Pharmacogenomics-Job-NJ-08817/829639/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS http://www.daiichisankyo-jobs.com/job/Edison-Sr-Scientist-Clinical-Pharmacogenomics-Job-NJ-08817/829639/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Job Title Study Manager, Clinical Pharmacology
Functional Area Research & Development
City Edison
State New Jersey
Job Description
Job Summary:

The incumbent will be responsible for the implementation and day-to-day coordination of TMCP studies conducted in North America or aligned territories. Drug candidates under investigation may belong to any therapeutic area, however the candidate will be responsible for delivering Oncology Phase 1 studies in a clinical setting. This individual will coordinate with the Clinical Pharmacologist and Translational Medicine Lead (as appropriate to the primary TMCP function responsible for the study) as well as other functional contacts to ensure TMCP studies are conducted according to the timelines and objectives set forth by the Operational Plan, and per Daiichi-Sankyo SOPs, SWPs and ICH GCP Guidelines.

Responsibilities:

Interface with Clinical Study Lead and Outsourcing to develop and manage project budgets for sites, contract research organizations (CROs) and other vendors; Manage CRO contacts and other vendors as needed.

Interface with Study Lead to develop and manage study timelines and track study milestones.

Coordinate activities within a multi-functional team to execute study protocols per timeline and budget.

Coordinate with CRO to review and provide input as needed to the following documents: Study Protocol, Statistical Analysis Plan and Clinical Study Report.

Work with CROs and Daiichi Sankyo Data Management to develop appropriate data collection documents including Case Report forms (CRFs), diaries, questionnaires, and completion manuals (or provide input to development of electronic CRFs and other supporting electronic documents).

Select and manage the contract Clinical Research Associate prepare and conduct study activities, which include the following:

Coordinate and/or conduct pre-study (including CRO kick-off meeting), initiation and interim monitoring visits; generate, review and/or approve trip reports as appropriate.

Collect, review, track and maintain regulatory documents from site (including review of ICF and HIPAA templates as part of pre-study activities); Order study drug supplies and maintain throughout study.

Manage day to day study issues with site including enrollment tracking, site communication, and CRF review and/or study data review (including diaries, questionnaires, and completion manuals, or electronic CRFs and supporting documents).

In collaboration with CROs, Daiichi Sankyo Data Management and (if appropriate) Biostatistics, manage collection of safety data before the between-dose safety review meetings or other types of interim data reviews.

Participate in review of database and database lock, including database review of Serious Adverse Events.

Education/Experience

Minimum Bachelor degree (BS in Life Sciences or Nursing is preferred); Advanced degree in a related field (MS, MPH, PhD or higher) strongly preferred.

Six years experience in research (at least 4 of these in Clinical Development) in a pharmaceutical or device company, Academic Research Organization or CRO (with a BS degree); Minimum of 4 years of clinical development experience with advance degrees.

Experience with Phase 1 clinical trials in multiple therapeutic areas will be an advantage and/or Oncology studies.

Complete understanding of the concepts and applications of clinical research, medical terminology and other disciplines involved in drug development. Computer literacy and proficiency in MS Word, Excel and PowerPoint (Access and Project desirable);

Advanced interpersonal, communication and organizational skills; Must be self-motivated with proven leadership capabilities.

Complete knowledge of GCP, FDA CFRs and ICH Guidelines. Ability to interpret data and to present results in a concise and clear manner. Working knowledge of the components and key content Requirements of IND & NDAs.
Ability to work in a multicultural environment and to lead interface between development teams and CROs. Ability to work independently on technical problems of diverse scope applying novel and creative approaches to resolve complex operational issues and propose improvement to existing processes.]]> Sat, 28 Aug 2010 00:08:00 http://www.daiichisankyo-jobs.com/job/Edison-Study-Manager,-Clinical-Pharmacology-Job-NJ-08817/813910/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS http://www.daiichisankyo-jobs.com/job/Edison-Study-Manager,-Clinical-Pharmacology-Job-NJ-08817/813910/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Job Title Director Clinical Safety
Functional Area Research & Development
City Edison
State New Jersey
Job Description
Job Summary:

The Clinical Safety Director will coordinate and lead the development and implementation of integrated project/product risk management strategies aimed at achieving the optimum benefit-risk for Daiichi Sankyo?s development compounds. This individual will use strong leadership and communication skills to successfully coordinate resources and ensure effective collaboration across development functions and sites. The individual assuming this role will function as a key member of the Integrated Project Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other departments to strategically manage benefit-risk throughout the lifecycle of the drug. Specific responsibilities will vary depending on the stage of development of assigned projects (i.e., Phase I through commercialization).

Responsibilities:

Develop processes and procedures for identifying and evaluating risk management issues for compounds in development. Effectively represent Risk Management department on the development Integrated Project Team providing risk management support and serving as the primary point of contact. Review and analyze data from clinical trials for the prompt identification of safety signals. Review and Evaluate serious adverse event reports from clinical trials for completeness, accuracy, expectedness and relatedness. Lead internal and external (especially regulatory, but also expert advisory) interactions to ensure quality outcomes in the risk management assessment of assigned projects/products. Define and implement strategies and action plans for managing risk management issues throughout the product life cycle. Effectively coordinate and manage available resources in developing and delivering high-quality risk management documents/deliverables (e.g., Risk Management Plans) to agreed timelines. Coordinate and participate actively and influentially in regulatory risk management activities (e.g., regulatory meetings, post-approval commitments).

Education/Experience

MD (or PhD in a relevant scientific discipline), Board certification or eligibility. 3-5 years experience in the pharmaceutical industry, regulatory agency or academia, with exposure to drug development, clinical pharmacology, and/or epidemiology. Senior Director 7- 10 years. Proven ability to effectively lead cross-functional teams and to influence where direct reporting line relationships do not exist. Ability to review and analyze data and communicate complex information and analyses to a variety of scientific and non-scientific audiences. Proven ability to think creatively and to develop strategic plans that demonstrate sound judgment. Experience working cross-culturally in a global pharmaceutical environment.]]> Mon, 30 Aug 2010 00:08:00 http://www.daiichisankyo-jobs.com/job/Edison-Director-Risk-Management-Job-NJ-08817/816974/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS http://www.daiichisankyo-jobs.com/job/Edison-Director-Risk-Management-Job-NJ-08817/816974/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Job Title Sr Director Health Economics and Outcomes Research
Functional Area Medical Affairs
City Parsippany
State New Jersey
Job Description
Job Summary:

We are currently seeking a Senior Director, Health Economics & Outcomes Research for our Parsippany, New Jersey location. This position will lead the development of scientifically rigorous and business-relevant HEOR plans and strategies for assigned compound(s); and processes in the R&D and Commercial organizations to facilitate development of compelling value proposition for DSI products.

Responsibilities:

In this role, you will provide strategic direction from HEOR perspective to cross-functional teams within therapeutic area(s) of responsibility during all phases of clinical development and commercialization; and is accountable for development of compelling value proposition for health policy makers, government & commercial payers, consumers and other stakeholders. Additionally, by demonstrating attention to detail, you will accurately interpret and present HEOR evidence, develop and approve HEOR materials in partnership with clinical, medical, legal and regulatory teams.

Education/Experience
Qualified candidates must have a Doctoral degree in Health Economics, Health Services Research, Medicine, Public Health, or Pharmacoepidemiology and a minimum of 12 years relevant experience in the healthcare industry with at least 8 years within a pharmaceutical company. Must have atleast 3 years of successful leadership and people management experience (HEOR specific), with five or more years preferred, and track record of effective application of HEOR data with external stakeholders in the United States and International markets clearly tied to successful business outcomes is required. Combination of leadership and hands on experience with HEOR research methodologies during all phases of product life cycle and knowledge of cardiology and oncology disease is preferred. Strong leadership and managerial skills, and ability to successfully influence cross functional teams including senior level clinical and commercial colleagues in order to drive the ?value proposition? development agenda are critical skills in this role. Must be willing to travel 20% of time.]]> Sat, 28 Aug 2010 00:08:00 http://www.daiichisankyo-jobs.com/job/Parsippany-Sr-Director-Health-Economics-and-Outcomes-Research-Job-NJ-07054/813911/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS http://www.daiichisankyo-jobs.com/job/Parsippany-Sr-Director-Health-Economics-and-Outcomes-Research-Job-NJ-07054/813911/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Job Title CMO Manager
Functional Area Research & Development
City Edison
State New Jersey
Job Description
Job Summary:

We are currently seeking a CMO Manager for our Edison, New Jersey location. This position is responsible for establishing, managing and overseeing new Daiichi Sankyo clinical CMC development programs at CMOs with a focus on project management and daily business operations for monoclonal antibody drug substances and drug products. The individual will manage external collaborations and provide supports in multiple programs as a liaison to internal groups in a global pharmaceutical company.

Responsibilities:

In this role, you will establish, manage and oversee CMC development at CMOs for the performance of process, analytical method and formulation development, as well as manufacturing and QC in GMP setting for all monoclonal antibody drug substances and drug products in global development programs, and for products distributed within the Unites States or its territories. Includes:

a) setting priorities and expectations with CMOs

b) coordinating activities between and setting timelines with CMO's and global Daiichi Sankyo departments/sites,

c) writing CMC led meeting agenda and meeting minutes,

d) approving and tracking invoices against contracts and budget,

e) directing investigations and change proposals,

f) ensuring scientific and technical consistency, and global quality compliance of the CMC documentation issued by CMO's,

g) managing the CMC information flow between supporting groups

You will also facilitate programs for technology transfer to CMO/CRO sites; support CMC development programs at CMOs for special projects for development and/or commercial product; create and maintain project CMC database; and archive product/raw material test methods, methods validation protocols and reports, Certificates of Analysis, stability protocols and respective stability data/report; and ensure compliance with the current FDA regulations, ICH guidelines and internal DSPD policies at multiple CMO sites.

Education/Experience
Qualified candidates must have a Master's degree in biology, microbiology, biochemistry, or chemical engineering with a minimum of 5 years experience, or a Bachelor's degree with a minimum of 8 years experience of hands on clinical and/or commercial industry experience in the manufacturing science of biologics (mAbs) and/or cell based therapeutics. Interaction with contract manufacturing organizations and biotech product companies is required and technology transfer and process scale-up are a plus. The skills needed for this position are adequate knowledge of cGMPs, regulatory Requirements, and CMC operations in a biotech company; and excellent negotiation and communication skills]]> Mon, 16 Aug 2010 00:08:00 http://www.daiichisankyo-jobs.com/job/Edison-CMO-Manager-Job-NJ-08817/855143/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS http://www.daiichisankyo-jobs.com/job/Edison-CMO-Manager-Job-NJ-08817/855143/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Job Title Staff Biostatistician
Functional Area Research & Development
City Edison
State New Jersey
Job Description
Job Summary:

Project leadership responsibilities; provides statistical guidance on range of topics and regular project updates; acts as a statistical consultant in regulatory and clinical forums and meetings across all projects and programs; seeks out and tests new statistical software; and seeks to broaden the utilization and acceptance of departmental expertise and support in areas outside of Clinical Development and Regulatory Affairs (e.g., Marketing, Preclinical, and Toxicology). This position has no direct reports.

Responsibilities:

In this role, you will serve as Project Biostatistician; collaborates globally to ensure worldwide acceptance of statistical design and analyses; ensures that study design, protocol preparation, and statistical analysis methodologies meet study/project objectives, and are in compliance with regulatory guidances.Demonstrates Daiichi-Sankyo core competencies at individual contributor level; exhibits Daiichi-Sankyo values.Ensures accuracy of all statistical analyses and interpretation in clinical study reports and of timelines for deliverables within assigned projects. Active participant in regulatory agency meetings and responds to regulatory requests and questions. Establishes the consistency of study designs, parameter algorithms and definitions, analyses and calculations, and reporting formats for all studies within assigned project. Identifies, tests, and validates new statistical software. Seeks to broaden the utilization and acceptance of departmental expertise and support in cross-functional areas throughout Daiichi-Sankyo.

Leads the preparation of the project ISE and ISS through development of statistical analysis plans for same. Acts as a statistical consultant to Senior Management and outside consultants to resolve statistical issues and to develop projects. Addresses specific statistical issues in the design of studies from Proof of Concept to Phase IV. Establishes novel statistical study designs and methodologies for enhancing early stage decision making.

Education/Experience
Qualified candidates must have Statistics, Biostatistics, or Mathematics: MS or PhD. PhD + 8 yrs or MS + 10 years of pharmaceutical industry experience; full knowledge of advanced statistical analytical methods, clinical trial research, regulatory Requirements, coding techniques, and statistical software. Excellent oral and written communication skills; project planning skills; demonstrated experience in analyzing clinical trial data; priority setting skills; multi-tasking skills; problem solving skills; eye for detail; exercise good judgment; and works well within team framework. Comprehensive project management skills. Demonstrated competency in SAS. Regular attendance at IDT Meetings is necessary; experience in managing CROs and external vendors.]]> Sat, 28 Aug 2010 00:08:00 http://www.daiichisankyo-jobs.com/job/Edison-Staff-Biostatistician-Job-NJ-08817/814981/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS http://www.daiichisankyo-jobs.com/job/Edison-Staff-Biostatistician-Job-NJ-08817/814981/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Job Title Senior Director, Clinical Development
Functional Area Research & Development
City Edison
State New Jersey
Job Description
Job Summary:

This position oversees and manages one global clinical development program with one or more indications, or multiple regional development programs, from early development to regulatory approval and beyond, in order to achieve a high quality product for the marketplace and business success.

Responsibilities:

In this role, you will prepare Clinical Development Plans, budgets and proposed go/no-go decision criteria for one global or multiple regional development programs ensuring the global and/or regional needs and Requirements are met; manage internal resources, external partners, consultants, vendors and external budget to ensure the timely and cost-effective implementation of the Clinical Development Plan for a global or multiple regional programs in therapeutic area; assess and recommend CROs and preferred vendors for implementation of clinical development plan for a global or multiple regional programs and review and approve contracts, work orders and invoices prior to submission to management for approval.

You will also represents Clinical Development in Integrated Project Teams to ensure high scientific, ethical and regulatory standards, and expeditious registration submissions worldwide; represent the company in operations or implementation committees overseeing co-development of therapeutic area programs with partners; establishes and maintains effective communication and collaboration with functional area peers, including basic research, manufacturing, regulatory, quality assurance, project management, and marketing, as well as thought leaders in order to meet program objectives and support achievement of department and corporate goals; provides input to non-clinical and commercial functions on medical needs and strategic issues for the therapeutic area; and support assessment of in-licensing product candidates in area of expertise, as needed.

Education/Experience

Qualified candidates must have MD degree. Board Certification in Internal Medicine with formal training in therapeutic area is highly desirable. PhD or PharmD degree candidates with extensive drug development experience are eligible and will work under the supervision of a MD Senior or Executive Director.

For MD, a minimum 5 years of pharmaceutical development experience and at least 2 years of hands-on experience managing a major, multi-country, clinical program.

For PhD or PharmD, a minimum of 8 years of drug development experience and at least 6 years of hands-on experience in clinical development.

Knowledge of pharmaceutical business, worldwide drug development and regulatory process.

Expertise in clinical trial design, conduct and interpretation of scientific data.

Independent thinking, creativity and innovation; ability to lead and manage global and multinational drug development programs/teams and to deliver high quality products; strong interpersonal skills and ability to interface effectively with multinational development and management teams in a multicultural working environment; excellent communication, presentation and negotiation skills with emphasis on building consensus; ability to effectively manage interactions with development partners and academic thought leaders ensuring optimal cooperation for achieving program and department goals; and ability to listen, motivate, lead and facilitate issue resolution in a multicultural working and business environment are important in this role.

For MD, clinical practice experience in therapeutic area is highly desirable.

For PhD and Pharm. D, track record of successful, innovate, non-clinical research in therapeutic area related field and a minimum of 6 years of industry experience in clinical research.

Must be willing to travel up to 20% of time.]]> Wed, 18 Aug 2010 00:08:00 http://www.daiichisankyo-jobs.com/job/Edison-Senior-Director,-Clinical-Development-Job-NJ-08817/829643/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS http://www.daiichisankyo-jobs.com/job/Edison-Senior-Director,-Clinical-Development-Job-NJ-08817/829643/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS Job Title Manager, Medical Writing
Functional Area Research & Development
City Edison
State New Jersey
Job Description
Job Summary:

We are currently seeking a Manager, Medical Writing for our Edison, New Jersey location. This position is responsible for the preparation of protocols, Investigator Brochures (IBs), Clinical Study Reports (CSRs), clinical sections of the CTD (2.5, 2.7.3, 2.7.4), integrated summaries of efficacy and safety (ISE and ISS), briefing books, and regulatory responses; and hands-on writing as well as supervision of work performed by CRO/consultant writers.

Responsibilities:

In this role, you will be coordinate and control medical writing activities of external writers with regards to company document templates, standards, and processes; critically review documents produced by external writers for scientific content and alignment with company position, clarity, accuracy, and consistency; act as a liaison between internal and external reviewers and the external writer; assist Clinical Study Managers with managing documents through the review process (coordinating document review meetings, collate and reconcile comments from various functional groups) and the approval process; and provide medical writing support for development programs by hands-on writing of protocols, IBs, and other documents

Education/Experience

Qualified candidates must have a PharmD, PhD in biological sciences. MD is strongly preferred. Otherwise exceptional candidates with a MS or BS/BA may be considered.

Minimum requirement of 3 years experience with PharmD or PhD, 5 years with Masters' Degree or 7 years with a BA/BS. Experience in writing regulatory documents (protocols, Investigator Brochures [IBs], Clinical Study Reports (CSRs), clinical sections of the CTD [2.5, 2.7.3, 2.7.4], integrated summaries of efficacy and safety [ISE and ISS], briefing books, and regulatory responses) in the pharmaceutical or CRO environment required; ability to interpret and organize scientific data; and general understanding of clinical research, biostatistics, electronic publishing, and relevant industry guidelines (GCP, eCTD, and ICH).

Marketing submission experience (NDAs or MAAs) preferred but not required.

Daiichi Sankyo develops or has developed drugs in the following therapeutic areas: cardiovascular diseases, metabolic diseases, inflammation and immunology, infectious diseases, and oncology.

Relevant therapeutic area experience preferred.

Ability to quickly get up to speed on a therapeutic area, project, or indication with little to no coaching, work concurrently on several complex projects, meet aggressive deadlines, and adjust priorities rapidly as the situation demands.

Strong interpersonal and communication skills (both verbal and written) are also required as the individual must be able to work in a team environment and coordinate with the team to move documents forward to completion.

Must be a self-motivated person who can work with limited guidance/supervision.

Excellent writing skills with a clear concise style and excellent grammar, punctuation, and spelling; proficiency in a Microsoft Windows environment; and strong MS Word skills and ability to work with templates.
Excellent attention to details, especially as related to accuracy of numbers/statements and consistency within and across documents.]]> Mon, 30 Aug 2010 00:08:00 http://www.daiichisankyo-jobs.com/job/Edison-Manager,-Medical-Writing-NJ-08817/865902/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS http://www.daiichisankyo-jobs.com/job/Edison-Manager,-Medical-Writing-NJ-08817/865902/?utm_source=J2WRSS&utm_medium=rss&utm_campaign=J2W%5FRSS