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Director/Senior Director, Drug Safety & Pharmacovigilance

1 hour, 22 minutes ago
United States
Full-time
Senior
Compliance Manager
Operations
Apply Now
Faeth Therapeutics

Faeth Therapeutics

Faeth Therapeutics is a biotechnology company focused on unlocking the power of metabolism to treat cancer. Their MetabOS platform provides insights into drug-nutrient interactions across all tumor types, leading to innovative cancer treatment approach...

Pharmaceuticals
11-50
$67M raised
View All Jobs 2

Description

  • Serve as the medical lead for pharmacovigilance and drug safety across clinical development programs.
  • Oversee safety processes, procedures, and vendor performance.
  • Review safety data from ongoing clinical trials and lead signal detection, evaluation, interpretation, and risk assessment.
  • Oversee safety surveillance activities conducted by CROs, pharmacovigilance vendors, and consultants.
  • Ensure compliant execution of global safety activities with pharmacovigilance operations and regulatory teams.
  • Lead development of safety content for protocols, investigator brochures, informed consent forms, clinical study reports, and regulatory submissions.
  • Support interactions with regulatory authorities on safety matters.
  • Lead Safety Management Team meetings and provide safety expertise to cross-functional development teams.
  • Collaborate with Clinical Development, Regulatory Affairs, Clinical Operations, Medical Writing, and Biostatistics to advance programs.
  • Help evolve the safety function as programs move into mid- and late-stage development.

Requirements

  • Minimum 4 years of pharmacovigilance and drug safety experience in the pharmaceutical or biotechnology industry.
  • Significant experience supporting oncology drug development programs.
  • Demonstrated expertise in medical safety assessment, signal detection, and risk management.
  • Experience overseeing CROs, pharmacovigilance vendors, and external consultants.
  • Working knowledge of global pharmacovigilance regulations and safety reporting requirements.
  • Experience supporting Phase 2 and/or Phase 3 clinical development programs.
  • Strong communication and cross-functional collaboration skills.
  • Ability to operate independently in a fast-paced, resource-efficient biotechnology environment.
  • MD degree (preferred).
  • Experience in both large pharmaceutical companies and small-to-mid-sized biotechnology organizations (preferred).
  • Prior experience as the primary or lead medical safety physician for a development program (preferred).
  • Experience supporting regulatory agency interactions related to drug safety (preferred).
  • Board certification in Oncology, Hematology/Oncology, Internal Medicine, or a related specialty (preferred).

Benefits

  • Competitive salary and equity in a well-funded, clinical-stage biotech.
  • Compensation range of $235,000 to $310,000, depending on experience, qualifications, and location.
  • 100% remote work and a flexible schedule.
  • Health, dental, and vision coverage for employees and dependents.
  • Flexible time off.
  • Generous parental leave.
  • Traditional and Roth 401(k).
  • Mission-oriented, remote-first culture.

Interested in this position?

Apply directly on the company website

Apply Now

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