Director/Senior Director, Drug Safety & Pharmacovigilance

Faeth Therapeutics•Austin, TX

2d•$235,000 - $310,000•Remote

About The Position

Faeth Therapeutics is a clinical-stage oncology company listed on Nasdaq that recently raised $200M in funding. With a strong scientific foundation and a founding team that includes the discoverer of our target pathway, we are advancing PIKTOR, a multi-node PI3K/AKT/mTOR inhibitor program, toward multiple near-term milestones. We are a small, focused team where every person has direct impact — united by a shared commitment to care deeply, create boldly, and never stop learning. Faeth Therapeutics is seeking an experienced physician leader to serve as Director/Senior Director, Drug Safety & Pharmacovigilance. This individual will provide medical leadership and strategic oversight for all pharmacovigilance activities across Faeth's clinical-stage oncology programs.

Requirements

Minimum 4 years of pharmacovigilance and drug safety experience within 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 clinical development programs in Phase 2 and/or Phase 3 development.
Strong communication and cross-functional collaboration skills.
Ability to operate independently in a fast-paced, resource-efficient biotechnology environment.

Nice To Haves

MD degree.
Experience in both large pharmaceutical companies and small-to-mid-sized biotechnology organizations.
Prior experience serving as the primary or lead medical safety physician for a development program.
Experience supporting regulatory agency interactions related to drug safety.
Board certification in Oncology, Hematology/Oncology, Internal Medicine, or a related specialty is preferred.

Responsibilities

Serve as the medical lead for pharmacovigilance and drug safety activities across Faeth's clinical development programs.
Ensure appropriate oversight of safety processes and procedures, and vendor performance.
Provide medical review and oversight of safety data from ongoing clinical trials and lead safety signal detection, evaluation, interpretation, risk assessment activities, review and provide medical input in the following documents: aggregate safety reports, DSURs, and other regulatory safety submissions.
Oversee safety surveillance activities conducted by external CROs, pharmacovigilance vendors, and consultants.
Own compliant execution of global safety activities with pharmacovigilance operations and regulatory team.
Lead development of safety sections of clinical study protocols, investigator brochures, informed consent forms, clinical study reports, and regulatory submissions.
Support interactions with regulatory authorities related to 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 support program advancement.
Help evolve Faeth's safety team as programs progress through mid- and late-stage clinical development.