Director, Drug Safety Physician

Role Summary:

The Director, Drug Safety Physician will play a pivotal role on our Drug Safety & Pharmacovigilance 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/AOSE for expedited safety reporting, contributing to safety assessment, safety surveillance, signal detection, risk management planning and strategy, clinical trial document review (protocol, IB, ICF), and ensuring pharmacovigilance compliance with global regulatory requirements.

Key Responsibilities:

• Perform triage and medical review of ICSRs (in 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.
• 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 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, surveillance plans.  
• Works closely and assists the Medical Review Lead 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 on study protocols, periodic reports (DSUR), safety management plans etc.  
• Participate in safety presentation development for independent Data Monitoring Committee (iDMC) meetings.
• Ensure that tasks are performed in the most efficient manner possible 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.
• Provide input to other safety activities as requested.
• Other duties as assigned. 

Ideal Candidate:

• MD with 6+ years of related Clinical Development Drug Safety/Medical Review experience within the biotech/pharmaceutical industry
• Working experience / proficiency in Argus global safety database and medical review activities
• 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 $315,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.