Role Summary:The Director, Drug Safety Physician, will play a pivotal role within the Drug Safety & Pharmacovigilance (DSPV) team, helping to advance the development of our cutting-edge antibody portfolio. This position's deliverables include Individual Case Safety Report (ICSR) review and aggregate safety monitoring (DSUR, etc.), oversight of cases/Analysis of Similar Events (AOSEs) for expedited safety reporting, contributing to ongoing safety assessment, safety surveillance, signal detection, risk management planning and safety strategy. The role will also provide medical safety input into key clinical trial document reviews, including protocols, IB, ICF, ensuring pharmacovigilance compliance with global regulatory requirements.
The position reports to Sr VP, Drug Safety and Pharmacovigilance with a dotted line reporting relationship to the Medical Review Lead.
Key Responsibilities:- Perform triage and medical review of ICSRs (in and/or outside the global safety database), and oversight of cases/AOSE for expedited safety reporting
- Lead cross-functional medical review discussions pertaining to Individual Case Safety Report (ICSR) review
- Participate in the preparation, writing, and/or review of aggregate safety review documents (DSUR) and safety sections of relevant clinical trial documents and regulatory filings
- Participates in and/or leads review of scientific literature, including preparation of written summaries to support aggregate safety analyses
- Participate in safety data review including safety surveillance activities and the evaluation & management of safety signals emerging from any data source
- Participate and co-present cases at safety management team (SMT) and safety review team (SRT) meetings and co-lead safety surveillance and signal management meetings
- Participate in process improvement projects related to medical review and assessment, safety surveillance, and relevant aspects of PV compliance
- Assist the DSPV department head in developing and maintaining state-of-the-art Pharmacovigilance (PV) processes and procedures including SOPs, WI, safety management plans, and safety surveillance plans
- Participate in safety presentation development for independent Data Monitoring Committee (iDMC) meetings
- Collaborate closely and assists the Medical Review Lead and other physicians on the team on the ongoing review of cases and in developing a unified approach for medical review of ICSRs, safety presentations (relevant to medical review of ICSRs and/or safety surveillance aspects), and provides ongoing input into study protocols, periodic safety reports (DSURs), safety management plans etc. Lead epidemiology projects with relevance for safety and pharmacovigilance (natural history of disease, comorbidities, class effects, population health data, real-world drug safety monitoring, literature searches, signal detection and data mining, comparative effectiveness and safety research)
- Ensure that all assigned activities are executed efficiently commensurate with quality, accuracy, and timeliness and in accordance with current global regulatory requirements
- Provide medical safety strategy and execution of benefit-risk management strategies for assigned products
- Provide safety input to clinical development plans, responses to HA or institutional review board/ ethics committee queries
- Provide input into the development of safety risk language, risk management strategy, pre-filing safety activities including safety table shells, integrated safety data review, integrated safety summary document review, and safety-focused publication development
- Other duties as assigned
Ideal Candidate:- MD with 6+ years of related Clinical Development Drug Safety/Medical Review experience within the biotech/pharmaceutical industry (medical review of ICSRs and periodic reports)
- A degree in epidemiology (Masters in Public Health, Masters of Science in Epidemiology, Doctor of Philosophy in Epidemiology, or Doctor of Public Health) or several years' working knowledge in Epidemiology/Pharmacoepidemiology,) is highly preferred
- Working experience / proficiency in Argus global safety database and medical review activities
- Working experience in safety surveillance and signal detection activities
- 2-3 years Medical Device safety experience is a strong preference
- Knowledge of global pharmacovigilance regulations (EMA, FDA, etc.) relevant to the activities and responsibilities described above
- Excellent analytical and problem-solving skills, with the ability to interpret complex data and translate findings into actionable drug development strategies
- Excellent communication and interpersonal skills, with the ability to motivate teams and collaborate effectively across functions
What We Offer:- Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.
- Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
- Unlimited PTO
- Two, one-week company-wide shutdowns each
- Commitment to provide professional development opportunities.
- Remote working environment with frequent in-person meetings to address complex problems and build relationships.
The expected salary range offer for this role is $280,000 to $311,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.
