Current jobs related to Associate Director, Clinical Safety MD - Basking Ridge - Planet Pharma
-
Director of Clinical Safety
1 month ago
Basking Ridge, New Jersey, United States Actalent Full timeJob Title: Director, Clinical SafetyAbout the RoleThe Director, Clinical Safety will be a key member of our team, responsible for ensuring the safety of our products throughout their lifecycle. This role involves leading safety surveillance and risk management efforts, providing safety leadership, and collaborating with cross-functional teams to...
-
Associate Director, Clinical Safety
1 week ago
Basking Ridge, United States Daiichi Sankyo Inc. 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 120 years of scientific expertise and a...
-
Basking Ridge, New Jersey, United States The Fountain Group Full time{"title": "Clinical Safety Scientist Associate Director", "subtitle": "Join The Fountain Group", "content": "Clinical Safety Scientist Associate DirectorWe are seeking a highly skilled Clinical Safety Scientist Associate Director to join our team at The Fountain Group. As a key member of our safety team, you will be responsible for proactively performing...
-
Associate Director Clinical Sciences Oncology
4 weeks ago
Basking Ridge, New Jersey, United States BioSpace, Inc. Full timeJob DetailsWe are seeking an experienced Associate Director to join our Oncology Clinical Development department. The successful candidate will lead the development, evaluation, planning, and execution of clinical studies, ensuring scientific integrity and interpretation of study data for a clinical development program. This role will involve leading a...
-
Director of Clinical Safety
4 weeks ago
Basking Ridge, New Jersey, United States The Fountain Group Full timeDirector, Clinical SafetyThe Fountain Group is seeking a seasoned professional to lead our client's clinical safety efforts. As a key member of the Global Product Team, you will be responsible for developing and implementing a comprehensive product safety strategy.Key Responsibilities:Develop and execute a product safety strategy that aligns with regulatory...
-
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...
-
Clinical Safety Scientist Lead
2 weeks ago
Basking Ridge, New Jersey, United States Hire Talent Full timeJob Title:Associate Director Clinical Safety ScientistJob Summary:We are seeking an experienced Associate Director Clinical Safety Scientist to lead our clinical safety and risk management efforts. The successful candidate will be responsible for proactively performing safety surveillance and risk management in partnership with cross-functional teams to...
-
Associate Director, Clinical Safety 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 Safety Scientist
1 month ago
Basking Ridge, United States Planet-Pharma Full time• This position serves as the Clinical Safety Scientist Lead for a large, late-stage program or multiple early-stage programs, in order to proactively perform safety surveillance and risk management in partnership with Product Safety Lead(s), Clinical Safety Physician(s), and cross-functional team in support of benefit risk profile throughout product...
-
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...
-
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...
-
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...
-
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...
-
Safety Leadership Director
1 day 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...
-
Clinical Safety Scientist Lead
2 weeks ago
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeJob Title: Associate Director, Clinical Safety ScientistAbout Daiichi Sankyo, Inc.Daiichi Sankyo, Inc. is a leading pharmaceutical company dedicated to creating innovative therapies to improve standards of care and address unmet medical needs globally. With a rich legacy of innovation and a robust pipeline of promising new medicines, we are committed to...
-
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 Safety Scientist Lead
1 month ago
Basking Ridge, New Jersey, United States The Fountain Group Full timeJob Title: Associate Director - Clinical Safety ScientistJob Schedule: The ideal candidate will be local and able to work in the office 1-2 days a week. Global Travel ~ 20% of Time. Pay rate: $100/Hr.Responsibilities & Job DetailsThis position serves as the Clinical Safety Scientist Lead for a large, late-stage program or multiple early-stage programs,...
-
Associate Director, Clinical Pharmacology
5 months ago
Basking Ridge, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and Counting!Company is committed to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing Clinical Pharmacology and Modeling & Simulation plans from FIH to post registration....
-
Director, Clinical Development
1 week ago
Basking Ridge, United States Daiichi Sankyo Full timeDirector, Clinical DevelopmentJoin a Legacy of Innovation 125 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 125 years of...
-
Associate Director, GMA Oncology
2 weeks 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 120 years of scientific expertise and a...
Associate Director, Clinical Safety MD
2 months ago
--
Duties:
Job Title: Associate Director, Clinical Safety MD
Job Schedule: Candidate can work 100% remote for duration of assignment. EST/CST time zone-based candidates preferred.
Position supports safety monitoring and risk management activities for products in development. This position will work closely with a senior physician. Additionally, this position works with other CSPV staff and cross functional Safety Management Team (SMT) members.
Responsibilities
· Signal Identification and evaluation: Carries out routine signal identification and evaluation activities for assigned products in development phase
· Risk Mitigation & Communication: Communicates any safety concerns to management and relevant team members.
· Responsible for responses to Health Authority inquiries on safety issues and prepares safety data for safety review boards.
· Present safety data in SMTs as a product safety expert
· Prepares, summarizes, and reviews aggregate safety analyses.
· Performs safety assessments and determines the safety profiles of assigned products.
· Provides integrated safety input into all safety relevant parts of regulatory documents (IB, CCDS, RMP, REMS, DSUR, PSUR, CSR, Clinical Overview and Integrate safety summary) required during active development, and submission phase.
· Defines the risk component of the B/R assessment.
Skills:
1-3 years of Pharmacovigilance (PV)/clinical safety experience in pharmaceutical drugs either from relevant work experience within the industry or related healthcare work. Demonstrated ability to implement strategy and processes and collaborate with others. Safety experience in clinical development preferred. Experience in rare disease is a plus.
Education:
MD/DO Degree Required (international MD degree is acceptable)
