Medical Director, Drug Safety
Initial Therapeutics, Inc.
brisbane, ca
Compensation: 307.000 - 351.000
Medical Director, Drug Safety
Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.
As a Medical Director, Drug Safety you will play a key role in ensuring the safety of patients in Nurix’s clinical trials. You will apply your clinical expertise to evaluate safety data, guide benefit–risk assessments and help shape the pharmacovigilance strategy for Nurix’s emerging therapies. You will report to the VP of pharmacovigilance and work closely with colleagues in clinical development, regulatory affairs, and clinical research to interpret emerging safety signals, support regulatory submissions, and maintain a strong safety framework during clinical development and transition into the post‑marketing phase. Your insights will help inform critical decisions about patient safety, risk management, and the overall development strategy for our products. This role is well suited for a physician who enjoys working at the intersection of non‑clinical data, clinical medicine, data interpretation, and drug development, and who wants to have a meaningful impact on how new therapies are evaluated and brought to patients.
Responsibilities
Medical Safety Leadership
- Serve as the medical safety lead for assigned products, providing clinical and pharmacovigilance expertise to safety strategy and activities.
- Lead aggregate safety data analysis for signal detection, signal evaluation, and risk characterization.
- Conduct medical review and interpretation of safety data, contributing to benefit–risk assessments.
- Monitor emerging safety signals and proactively address potential safety risks through appropriate internal and external communication.
Regulatory and Safety Documentation
- Contribute to safety responses to regulatory authorities and participate in regulatory interactions.
- Provide clinical leadership during inspections and audits related to safety and risk management.
- Author and review regulatory safety documents, including:
- DSURs
- Safety sections of INDs, and regulatory briefing books.
Clinical Development Support
- Provide clinical input into safety aspects of clinical trial protocols, informed consent forms, and investigator brochures.
- Collaborate with clinical development, regulatory affairs, medical affairs, and other stakeholders to ensure a consistent global safety strategy.
- Governance and Cross-Functional Collaboration
- Serve on safety governance committees, supporting strategic decision-making for risk mitigation and benefit–risk evaluation
Requirements
- Medical degree (MD) is required
- Clinical experience preferred
- 10+ years of experience in pharmacovigilance/ drug safety within the pharmaceutical or biotechnology industry
- Demonstrated expertise in aggregate safety analysis and benefit–risk evaluation
- Strong knowledge of global pharmacovigilance regulations and guidance (ICH, FDA, EMA, MHRA)
- Experience supporting early and late-stage clinical development, regulatory submissions, and product launch
- Experience in post-marketing safety surveillance and risk management
- Experience interacting with global health authorities on safety matters
- Familiarity with signal detection and safety surveillance tools and databases
- Strong communication, collaboration, and cross-functional leadership skills
- Ability to interpret complex clinical and safety data and translate insights into regulatory and business strategy
- Ability to work effectively and collaboratively in a fast‑paced, growing organization
- This is an onsite position located in Brisbane, CA .
Fit with Nurix Culture and Values
- Strong team orientation; highly collaborative
- Solutions and results-oriented focus
- Hands‑on approach; resourceful and open to diverse points of view
Salary Range
307K - 351K plus bonus & equity
Nurix is an Equal Opportunity Employer offering a competitive salary and benefits package. Applicants should be legally entitled to work for any employer in the US.
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