Current jobs related to Director, Clinical Pharmacology - Basking Ridge - Daiichi Sankyo
-
Clinical Pharmacology Director
3 weeks ago
Basking Ridge, New Jersey, United States Daiichi Sankyo Inc. Full timeJob SummaryWe are seeking a highly skilled Clinical Pharmacology Director to join our team at Daiichi Sankyo, Inc. This is a critical role that requires a deep understanding of pharmacokinetics and pharmacodynamics, as well as experience in drug development and clinical trials.Key ResponsibilitiesDevelop and implement model-based drug development plans for...
-
Quantitative Pharmacology Director
3 weeks ago
Basking Ridge, New Jersey, United States BioSpace, Inc. Full timeJob SummaryWe are seeking a highly skilled Associate Director, Quantitative Pharmacologist to join our team. As a key member of our Quantitative Pharmacology group, you will be responsible for providing expert-level pharmacometrics support in one or more therapeutic focus areas.Key ResponsibilitiesDevelop and implement strategic analyses in support of...
-
Quantitative Pharmacology Director
5 days ago
Basking Ridge, New Jersey, United States BioSpace, Inc. Full timeJob OverviewWe are seeking a highly motivated Associate Director in Quantitative Pharmacology to join our team. The successful candidate will be responsible for providing hands-on pharmacometrics support in one or more therapeutic focus areas. This includes developing and implementing strategic analyses in support of research and development projects, taking...
-
Manager, Quantitative Clinical Pharmacology
1 month ago
Basking Ridge, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a...
-
Associate Director Clinical Science
4 weeks ago
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeJob Title: Associate Director, Clinical ScienceJob Summary:Daiichi Sankyo, Inc. is seeking an experienced Associate Director, Clinical Science to join our team. This role will oversee non-pivotal trials, prepare clinical sections of regulatory documents, and collaborate with AROs/CROs.Responsibilities:Develops biomarker strategies in collaboration with...
-
Clinical Science Director
2 weeks ago
Basking Ridge, New Jersey, United States BioSpace, Inc. Full timeJob OverviewAs a Clinical Science Director at Daiichi Sankyo, you will oversee one or more trials of medium to high complexity in design and geographic scope. This role requires strategic direction, clinical expertise, and leadership skills to drive the success of our clinical development programs. Key ResponsibilitiesDevelop and implement clinical study...
-
Associate Director Clinical Science
3 weeks ago
Basking Ridge, New Jersey, United States Daiichi Sankyo Inc. Full timeJob Title: Associate Director, Clinical ScienceCompany: Daiichi Sankyo Inc.Job Type: Full-timeLocation: GlobalAbout the RoleThe Associate Director, Clinical Science will oversee a single non-pivotal trial, preparing the clinical section of regulatory documents and collaborating with AROs/CROs. This role will provide medical and/or scientific direction to...
-
Clinical Science Director
3 weeks ago
Basking Ridge, New Jersey, United States Daiichi Sankyo Inc. Full timeJob Title: Clinical Science DirectorJob Summary:Daiichi Sankyo Inc. is seeking a highly skilled Clinical Science Director to lead our clinical development efforts in oncology. As a key member of our team, you will be responsible for overseeing the design, execution, and delivery of clinical trials, ensuring the highest quality and regulatory compliance.Key...
-
Associate Director, Clinical Science
2 weeks ago
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeJob Title: Associate Director, Clinical ScienceAbout the Role:Daiichi Sankyo, Inc. is seeking an experienced Associate Director, Clinical Science to join our team. In this role, you will oversee clinical trials, prepare regulatory documents, and collaborate with AROs/CROs. You will also provide medical and scientific direction to Clinical Operations and...
-
Clinical Director, Oncology Research
4 days ago
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeLead Clinical Development in OncologyDaiichi Sankyo, Inc. is seeking a highly skilled Clinical Director to lead clinical development in oncology. As a key member of our team, you will oversee non-pivotal trials, prepare clinical sections of regulatory documents, and collaborate with AROs/CROs.Key Responsibilities:Develop study strategies and provide input on...
-
Associate Director Clinical Science
2 weeks ago
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeAssociate Director, Clinical ScienceAbout the RoleWe are seeking an experienced Associate Director, Clinical Science to join our team at Daiichi Sankyo, Inc. This is an exciting opportunity to lead clinical development projects and contribute to the creation of innovative pharmaceutical therapies.Key ResponsibilitiesStudy Strategy: Develop and implement...
-
Regulatory Writing Associate Director
3 weeks ago
Basking Ridge, New Jersey, United States BioSpace, Inc. Full timeJob Summary:The Associate Director of Regulatory Writing is a key role responsible for producing scientifically accurate, high-quality clinical regulatory documents while adhering to regulatory guidelines. This position requires collaboration across various functions to meet aggressive timelines. Clinical regulatory documents include, but are not limited to,...
-
Basking Ridge, New Jersey, United States Daiichi Sankyo Inc. Full timeAbout Daiichi Sankyo Inc.Daiichi Sankyo Inc. is a global pharmaceutical company dedicated to creating innovative therapies to improve healthcare outcomes. With a rich legacy of innovation and a robust pipeline of promising new medicines, we are committed to addressing unmet medical needs and improving the lives of people worldwide.Job SummaryWe are seeking a...
-
Associate Director, Clinical Science
4 days ago
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeStudy Strategy:Develops and implements the strategic direction for clinical trials, collaborating with Biostats, Data Management, and Data Operations to ensure EDC, edit checks, data quality listings, SAP, and Data Management plans are aligned with study objectives.Study Planning and Execution:Provides input on major milestones, clinical trial plans, and...
-
Safety Leadership Director
3 days ago
Basking Ridge, New Jersey, United States Actalent Full timeJob Title: Director, Clinical SafetyAbout the Role:The Director, Clinical Safety, will be a product safety lead or part of a product safety team, responsible for overall product safety strategy or specific areas of safety surveillance and risk management.This role provides safety leadership including but not limited to clinical studies, post-marketing...
-
Associate Director, Clinical Science
1 week ago
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeStudy Strategy:Develops and implements clinical study strategies to ensure successful trial execution. Collaborates with Biostats, Data Management, and Data Operations to design and implement data management plans, edit checks, and data quality listings. Reviews patient population and protocol compliance to ensure consistency with study strategy.Study...
-
Director, Clinical Science
4 months ago
Basking Ridge, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a...
-
Associate Director, Clinical Science
5 months ago
Basking Ridge, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a...
-
Associate Director, Clinical Scientist
5 months ago
Basking Ridge, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a...
-
Associate Director Clinical Science
2 weeks ago
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeJob Title: Associate Director, Clinical ScienceAt Daiichi Sankyo, Inc., we are seeking an experienced Associate Director, Clinical Science to join our team. This role will oversee the strategic direction of clinical trials, providing medical and scientific guidance to Clinical Operations. The successful candidate will have a strong background in clinical...
Director, Clinical Pharmacology
2 months ago
Join a Legacy of Innovation 110 Years and Counting
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Job Summary:
The primary responsibilities of this position are to create the model-based drug development plan, design, conduct, and interpret Phase 1 (specifically Clinical Pharmacology) studies, support Phase 2/3 studies, represent function on study and project teams, and participate in and contribute to regulatory and KOL meetings. This position requires significant understanding of PK-PD and Pop PK-PD concepts and analysis, phase 1-4 clinical studies, literature, regulatory guidelines, and physiological/pharmacological aspects of the drug. This position effectively works independently for all phases of studies and participates in KOL and regulatory interactions at a project level, and interacts with regional and global project team members, senior management, and outside vendors.
Responsibilities:
Responsible for all aspects of Clinical Pharmacology and Biopharmaceutics studies and model-based drug development plans, serves as QCP subteam leader / clinical pharmacology project team representative, supports Phase 2/3 clinical pharmacology objectives with high-level supervision, participates in due-diligence activities, and represents global function on study and project teams.
Produces independent writing for publications and regulatory documents.
Serves as a specialist in PK-PD and Pop PK-PD concepts and independently performs PK-PD analyses, functions as Study Team Leader for Phase 1 Clinical Pharmacology studies, and provides clinical pharmacology input and support for other phase 1-4 clinical studies. Maintains up-to-date knowledge of relevant literature and regulatory guidelines.
Participates in KOL and regulatory interactions at project level, interacts with regional and global study and project team members, and to a limited extent with senior management and outside vendors
Mentors more junior department members, and provides information sharing within and between departments.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education: (from an accredited college or university)
PhD in pharmacology or pharmaceutical sciences or PharmD with a clinical pharmacology research fellowship required.
Experience:
7 or more years relevant experience required
4 or more years drug development industrial experience preferred
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
