Associate Director, Clinical Drug Safety

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in pharmacovigilance efforts associated with Centessa’s clinical-stage development programs.

• Examine and evaluate safety data for ongoing safety monitoring, signal management, regulatory adherence, and program execution.

• Aid in the production of aggregate reports and conduct literature reviews.

• Implement strategies for signal identification and management in collaboration with Drug Safety and cross-functional partners.

• Analyze aggregate safety data, pinpoint emerging safety signals, and contribute to risk–benefit evaluations.

• Review adverse events and other safety-related data for signal detection purposes.

• Oversee literature monitoring and disseminate clinically significant findings.

• Coordinate signal review initiatives and prepare safety governance presentations and meeting minutes.

• Provide scientific insights for DSURs, line listings, and other aggregate reports.

• Supervise the strategy, preparation, and timelines for DSUR in collaboration with cross-functional partners and vendors.

• Offer scientific contributions to the safety sections of protocols, Investigator’s Brochures, and regulatory submissions.

• Act as the primary drug safety representative on cross-functional study teams.

• Shape safety strategies, influence decision-making in programs, and advise on managing safety issues.

• Collaborate with clinical development, clinical operations, regulatory affairs, medical writing, and quality assurance teams.

• Review complex cases and assist in creating regulatory-ready case narratives and submissions, including SUSARs.

• Oversee vendor-led ICSR and clinical trial SAE evaluations.

• Lead or participate in cross-functional safety projects, signal assessments, and ad hoc scientific analyses.

• Ensure that drug safety activities adhere to changing regulations.

• Support the implementation, execution, maintenance, and enhancement of safety processes.

⛳️ Requirements

• RN, PhD, PharmD, MS, or BS degree in health sciences or a related field is required.

• A minimum of 6 years of experience in drug safety within the biotech/pharmaceutical industry.

• At least 3 years of experience in pharmacovigilance compliance.

• Comprehensive knowledge of safety signal identification, evaluation, and escalation processes, including governance frameworks and contributions to labeling updates.

• Proficiency in aggregate safety data analysis, ongoing safety monitoring, and risk–benefit assessments for investigational products.

• Experience in overseeing and interpreting medical literature surveillance.

• Expertise in the scientific review and preparation of DSURs, line listings, aggregate safety summaries, Investigator’s Brochures, protocols, and regulatory submissions.

• Advanced understanding of global drug safety/pharmacovigilance regulations, guidelines, and best practices.

• Scientific expertise in ICSR and clinical trial SAE assessment, including causality, seriousness, expectedness, and regulatory reportability.

• Experience in guiding the preparation of SUSARs.

• Capability to provide scientific and quality oversight of vendor-led safety activities.

• Technical proficiency as a drug safety subject matter expert on cross-functional teams.

• Advanced degree (PharmD or PhD preferred).

• Experience in CNS preferred.

• Strong analytical skills with a keen eye for detail.

• Excellent communication skills and the ability to work effectively within small, cross-functional teams.

🏝️ Benefits

• Company bonus based, in part, on both company and individual performance.

• Company-sponsored 401(k) plan.

• Pension plan.

• Vacation benefits.

• Medical, dental, vision, and prescription drug benefits.

• Flexible benefits, including healthcare and/or dependent daycare flexible spending accounts.

• Life insurance and death benefits.

• Certain time-off and leave of absence benefits.

• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.