Jobs · Healthcare · California

Medical Director, Drug Safety

BioSpace · Brisbane, CA · 4 wk ago
HealthcareFull-time

Responsibilities

  • 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.
  • 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.

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 pharmacovigivalence 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

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

Pay

$307K - $351K plus bonus & equity

Application Process

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.

About the Role

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 clinicaldevelopment, 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.

Discipline

Administration, Clinical, Manufacturing & Production

Required Education

Doctorate/PHD/MD

Position Type

Full time

Hotbed

Biotech Bay

Similar jobs

Medical Director

Sanitas Medical CentersRiverview, FL· 4 days ago
Healthcareapply on paycomonline.net

Medical Director

WPS—A health solutions companyMichigan, United States· 4 days ago
apply on recruiting2.ultipro.com

Medical Director

WPS—A health solutions companyMinnesota, United States· 4 days ago
apply on recruiting2.ultipro.com

Medical Director

WPS—A health solutions companyMissouri, United States· 4 days ago
apply on recruiting2.ultipro.com

Medical Director

Quest DiagnosticsPittsburgh, PA· 3 wk ago
Healthcare$11/hrapply on hdox.fa.us6.oraclecloud.com

Medical Director

Wexford Health SourcesIndustrial, WV· 6 mo ago
Healthcareapply on jobs.wexfordhealth.com