Principal Scientist, Drug Safety
Merck
Merck seeks a physician leader to direct clinical risk management and pharmacovigilance for investigational and marketed products. The role involves developing safety strategies, chairing risk management teams, and collaborating across functions to ensure robust benefit-risk evaluation throughout the product lifecycle.
Responsibilities
- Chair Risk Management and Safety Team for assigned products and participate on development teams
- Evaluate safety data from trials, literature, and post-approval use; lead surveillance activities
- Develop and maintain risk management and pharmacovigilance plans for assigned products
- Provide medical oversight for regulatory documentation including Risk Management Plans and safety submissions
- Collaborate with clinical development, epidemiology, regulatory, biostatistics, and manufacturing teams
Requirements
- M.D., D.O., or equivalent medical degree
- Minimum 3 years clinical experience post-training or relevant clinical background
- Demonstrated leadership in clinical safety, pharmacovigilance, or drug development
- Strong medical judgment and ability to assess complex safety information
- Excellent communication, writing, and analytical skills
- Ability to collaborate effectively across matrixed organizations
- Board certification preferred
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Principal Scientist, Drug Safety in North Wales, PA vacancy
$190.8k - $300.3k
Job DescriptionThe Nonclinical Drug Safety (NDS) Therapeutic Area Leader (TAL) is a senior scientific leader responsible for advancing... ...Coordinators, Discovery Preclinical Leaders, Compound Leaders, and scientists across NDS and/or Preclinical Development, while ensuring...PrincipalFull timeFor contractorsLocal areaFlexible hours$231.9k - $365k
...infectious diseases.Our Company's Research Laboratories nonclinical drug safety department at West Point, Pennsylvania site is seeking an... ...anatomic pathologist to join a highly collaborative team of scientists (12 anatomic pathologists, 3 clinical pathologists, and...PrincipalFull timeFor contractorsLocal area- ...way. Learn more at We are searching for the best talent for Principal Scientist, Protein Purification, Team Lead in Spring House, PA., Purpose... ...pharmaceutical or biotechnology experience in biologics or drug discovery. Demonstrated experience leading and developing scientists...PrincipalLocal area
$173.2k - $272.6k
...Research & Development Division in West Point, Pennsylvania, is seeking a dynamic and collaborative scientist for the Drug Metabolism and Pharmacokinetics (DMPK) group. The Principal Scientist will be a key contributor to multi-disciplinary drug development and discovery...PrincipalFull timeFor contractorsLocal areaFlexible hours$255.8k - $402.7k
...exciting opportunity for a physician-scientist to join our group as a Principal Scientist (Clinical Director) in... ...discovery research, biostatistics, drug metabolism, modeling and simulation... ...preclinical stage through Phase 1 studies of safety, tolerability, pharmacokinetics and...PrincipalFull timeFor contractorsLocal areaWorldwideFlexible hours- MSD Malaysia is seeking a Principal Scientist (Clinical Director) in Translational Medicine/Early Clinical Development for the Neuroscience therapeutic area in the US. The role requires a physician-scientist with neurology or psychiatry training and a strong translational...Principal
$190.8k - $300.3k
...Senior Principal Scientist leading nonclinical drug safety strategy for immunology programs at Merck. Responsible for overseeing development progression, regulatory submissions, and post-marketing support while mentoring scientists and influencing cross-functional partnerships...Principal- ...Senior Principal Scientist position leading clinical research strategy and execution for oncology drugs across all development phases. Responsible for study design, trial management, regulatory submissions, and cross-functional collaboration within a global healthcare...Principal
- ...Merck seeks a Principal Scientist to lead biomarker strategy development across neuroscience drug development programs. The role involves designing translational and clinical biomarker approaches that inform clinical decisions from early through late-stage development,...Principal
- Johnson & Johnson Innovative Medicine seeks a Principal Scientist to lead AI-powered discovery systems at Spring House, PA, with no remote option... ...and collaborate with cross-functional teams to accelerate drug discovery and improve decision quality through scalable, production...PrincipalRemote work
- Johnson & Johnson Biologics Discovery in Spring House, PA seeks a Principal Scientist, Protein Purification, Team Lead to guide a multidisciplinary group delivering purified antibodies, multispecifics, and other biologics for preclinical studies. You will set purification...Principal
$137k - $235.75k
.... Learn more at Purpose: The Senior Principal Scientist will be a key member of discovery project... ...with biology, chemistry, and other drug metabolism and pharmacokinetic (DMPK) project... ...Principal Scientist, Preclinical Safety & Translational Sciences-Translational...PrincipalLocal area$190.8k - $300.3k
Job DescriptionDescriptionThe Senior Director (Sr. Principal Scientist), Regulatory Affairs Liaison reports to the Executive Director or Associate... ...for one or more company investigational and marketed drugs/biologics. This position requires a leader with a strategic mindset...PrincipalFull timeFor contractorsLocal areaWorldwideFlexible hours- Johnson & Johnson Biologics Discovery in Spring House, PA seeks a Principal Scientist, Protein Purification, Team Lead to guide a team delivering purified antibodies, multispecifics, and other proteins for preclinical studies. You will set purification strategy, advance...Principal
$173.2k - $272.6k
...Merck seeks a Principal Scientist in Drug Metabolism and Pharmacokinetics to support multi-disciplinary drug development and discovery efforts. The role involves designing and interpreting analyses across small molecules and biologics, assessing program risks, authoring...Principal$142.4k - $224.1k
Job DescriptionWe are seeking an Associate Principal Scientist to join our Separations Sciences team, within the Analytical Enabling Capabilities... ...Techniques, Chromatography, Cross-Functional Teamwork, Drug Development, External Collaboration, High Resolution Mass Spectrometry...PrincipalFull timeFor contractorsLocal areaFlexible hours$173.2k - $272.6k
...treatment of diseases in people and animals.We are seeking a Principal Scientist to join our Analytical Commercialization Technology (ACT) group... ...to drive late-stage small molecule pharmaceutical drug product development and commercialization.The Principal Scientist...PrincipalFull timeFor contractorsLocal areaFlexible hours- Role Principal Scientist in High-Content Imaging within Johnson & Johnson's Innovative Medicine division, focusing on advancing therapeutic discovery... ...in Immunology, Neuroscience, and Oncology, with a focus on drug discovery workflows. The position is based in Spring House,...Principal
$173.2k - $272.6k
Job DescriptionJob Description Summary: Principal Scientist/Director, Biologics Drug Substance CommercializationJoin Our Company’s Manufacturing Division as a Principal Scientist/Director in Biologics Drug Substance Commercialization (BDSC). This senior leadership role...PrincipalFull timeContract workFor contractorsLocal areaFlexible hours- ...Principal Scientist role in Biostatistics leading late-stage clinical development projects. Provides statistical expertise for drug and vaccine development, manages cross-functional teams, and ensures compliance with regulatory requirements throughout the clinical trial...PrincipalWorldwide
$156.9k - $247k
Job DescriptionAssociate Principal Scientist/Associate Director, V&I Outcomes Research, HIVRole SummaryThe Associate Principal Scientist/Associate Director, Value & Implementation (V&I) Outcomes Research, position resides in the V&I organization, which includes Global Medical...PrincipalFull timeFor contractorsLocal areaWorldwideFlexible hours- ...Principal Scientist position in biologics optimization at Johnson & Johnson's Spring House, PA facility. Leads integration of experimental data... ...insights, and automation technologies to advance biologic drug discovery and establish design principles for molecule optimization...Principal
- ...Merck seeks a physician-scientist to lead translational medicine and early clinical development for neuroscience therapeutics. The role bridges discovery and clinical research, with responsibilities spanning target validation, clinical trial design, biomarker development...Principal
- Leadership position in translational medicine focused on cardiovascular therapeutic development. Responsible for early clinical strategy from preclinical approval through Phase 2 proof-of-concept, including biomarker development and clinical pharmacology studies in collaboration...Principal
$142.4k - $224.1k
...Merck seeks an Associate Principal Scientist in Separations Science to develop analytical methods supporting vaccine and biologic development. The role involves designing chromatography and characterization strategies within a collaborative analytical team at the West...Principal- Job Description Description The Senior Director (Sr. Principal Scientist), Regulatory Affairs Liaison reports to the Executive Director or Associate... ...IND/CTAs for global studies related to investigational drugs/biologics. Participates in regulatory due diligence activities...PrincipalLocal areaWorldwide
$173.2k - $272.6k
...Merck seeks a Principal Scientist to lead analytical chemistry efforts for small molecule drug product development and commercialization. The role involves managing a team, conducting method development and validation, supporting regulatory submissions, and mentoring...Principal- ...Merck seeks an Associate Principal Scientist to lead sterile drug product commercialization for biologics and combination products. The role encompasses process scale-up, technology transfer, process validation, and regulatory submissions for late-stage and commercial...Principal
- ...Senior Principal Scientist leading clinical research strategy and execution for breast cancer oncology medicines across all development phases... ...of clinical trials for investigational and marketed oncology drugs Analyze clinical study findings and prepare reports supporting...Principal
$156.9k - $247k
...Associate Principal Scientist position in Value & Implementation Outcomes Research focused on HIV. Responsible for designing and executing real-world evidence studies, health economic analyses, and reimbursement dossiers to support product value demonstration globally....PrincipalLocal area
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Principal Scientist, Drug Safety. Be the first to apply!
Related searches
- support scientist North Wales, PA
- senior research scientist North Wales, PA
- scientist North Wales, PA
- research scientist North Wales, PA
- qc scientist North Wales, PA
- senior principal scientist North Wales, PA
- water quality scientist North Wales, PA
- deep learning scientist North Wales, PA
- quality control scientist North Wales, PA
- machine learning research scientist North Wales, PA


