POSITION SUMMARY: The Drug Safety Physician in Drug Safety & Pharmacovigilance department will serve as a subject matter expert and thought leader for drug safety activities across Rigel's portfolio. This role requires broad expertise in oncology drug development, precision medicine biomarkers, and global regulatory frameworks. The position leads the application of existing principles while guiding development of new safety approaches for novel therapeutic modalities.
ESSENTIAL DUTIES AND RESPONSIBILITIES: - Medical Review of Individual Case Safety Reports (ICSRs)
- Perform comprehensive medical review of Individual Case Safety Reports (ICSRs) from clinical trials and post-marketing sources.
- Assess the clinical significance, seriousness, expectedness, and causality of adverse events using medical judgment.
- Provide the company's medical causality assessment for serious adverse events (SAEs), SUSARs, and post-marketing cases.
- Review medical narratives and ensure the medical accuracy and consistency of case documentation.
- Analyze similar cases and perform case series evaluations to support signal detection and regulatory decision-making.
- Provide medical guidance to case processing teams and ensure compliance with global pharmacovigilance regulations.
- Perform medical review of aggregate safety data in standardized regulatory reports, including Investigator Brochures, Developmental Safety Update Reports, Periodic Benefit Risk Event Reports, Periodic Safety Update Reports, to confirm a balanced and medical driven presentation and to assist in the identification of potential medicinal product risks, associated with signal detection.
- Ensure appropriateness of MedDRA and WHO-DD coding in collaboration with by CRO DSPV staff with input from Medical Reviewer.
- Coordinate the submission of expedited and periodic safety reports to regulatory authorities and distribution to partner companies and other organizations as required.
- Oversee the set-up of new safety projects, including development of study-specific Safety Management Plan and set-up of study-specific safety systems and processes (as needed).
- Expert Safety Data Analysis & Signal Management
- Lead evaluation of complex drug safety data to identify safety signals and evaluate signals for evidence of causal association with precision oncology products, applying advanced analytical techniques and clinical judgment
- Conduct sophisticated signal detection activities using advanced tools and methodologies, integrating preclinical, clinical, and literature data sources
- Advanced Safety Document Authoring & Review
- Lead preparation of complex summary drug safety evaluations including IND Annual Reports, PADERs, DSURs, PSURs, and integrated safety summaries for precision oncology programs
- Author and review safety sections of clinical study reports, protocols, and regulatory submissions with advanced understanding of biomarker-driven safety considerations
- Strategic Department Operations & Policy Development
- Lead department operations including procedural strategies, advanced training programs, service provider oversight and management, and regulatory audit preparations
- Drive establishment of departmental policies, business strategies, and procedural compliance with corporate and regulatory requirements across multiple jurisdictions
- Cross-Functional Leadership & Stakeholder Management
- Serve as primary liaison with therapeutic leads, safety physicians, biostatisticians, and key stakeholders on critical projects requiring advanced safety expertise
- Represent the Drug Safety Department in cross-functional clinical team meetings, providing expert guidance on complex safety matters
- Complex Problem Solving & Innovation
- Apply extensive knowledge of drug safety, disease-specific clinical knowledge, and business objectives to solve significant problems in creative and effective ways
- Lead innovative approaches to safety monitoring for novel therapeutic modalities including ADCs and precision medicine products
KNOWLEDGE AND SKILL REQUIREMENTS: - MD or equivalent advanced degree required
- Minimum 8-12 years of progressive drug safety and pharmacovigilance experience in biopharmaceutical industry
- Minimum 3-4 years in leadership roles with safety team management responsibility
- Demonstrated expertise in oncology drug development and precision medicine approaches
- Experience with novel therapeutic modalities including targeted therapies and biomarker-driven development
- Deep knowledge of global pharmacovigilance regulations (ICH, FDA, EMA, GVP) and precision medicine guidance
- Extensive experience with regulatory submissions for complex oncology products
- Advanced expertise in safety signal detection methodologies and benefit-risk assessment frameworks
- Experience integrating biomarker data into safety monitoring and risk management strategies
- Proven ability to influence and collaborate with cross-functional stakeholders
- Excellent written and verbal communication skills with ability to present complex safety concepts
- Experience interfacing with regulatory authorities on safety matters
- Previous biotech/pharmaceutical industry experience with marketed products
COMPENSATION AND BENEFITS: The anticipated salary range for this position is National $210,000 to $250,000 and, Premium Market (SFBA/NYC/Boston Area) $225,000 to $270,000. The actual salary offered will depend on several factors, including experience, qualifications, geographic location, internal equity, and business needs.
This position is eligible to participate in Rigel's annual bonus program and is eligible for equity incentive awards, subject to the terms of the applicable plans. This position is not commission-based.
Rigel offers eligible employees a comprehensive benefits package, including medical, dental, and vision coverage; life and disability insurance; flexible spending accounts; a 401(k) plan; paid time off; paid company holidays; and other benefits.
