Director, Pharmacovigilance

POSITION SUMMARY:

The Director, Pharmacovigilance provides strategic and operational leadership for Rigel's Drug Safety and Pharmacovigilance function. The role is accountable for the safety strategy, governance, medical oversight, regulatory compliance, and continuous improvement of safety activities across Rigel's development and marketed-product portfolio.

Reporting to the EVP, Chief Medical Officer, this leader sets and executes pharmacovigilance strategy; establishes scalable safety processes and governance; and directs the assessment, communication, and management of product risk including safety surveillance and signal detection. The Director partners closely with Clinical Development, Regulatory Affairs, Medical Affairs, Quality, Biostatistics, Alliance Management and external stakeholders to ensure that safety decisions are scientifically sound, compliant, timely, and aligned with Rigel's corporate and patient-care objectives.

Regular onsite presence is required to support cross-functional collaboration, team engagement, and business operations. Employees designated as onsite or hybrid who reside within the local commuting area are expected to work onsite at Rigel’s South San Francisco headquarters during normal business hours each Wednesday and Thursday. Employees designated as remote are expected to work onsite during normal business hours for a minimum of two Wednesday/Thursday business-day periods per month, as scheduled with management, and more frequently as business needs require.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Pharmacovigilance Leadership

• Own the Pharmacovigilance operating model, including strategic planning, policies, procedures, systems, quality metrics, and continuous process improvement.
• Establish and lead safety governance, including escalation and resolution of significant safety issues, benefit-risk positions, and risk-management recommendations.
• Provide medical and scientific oversight of safety assessments, including individual and aggregate safety data, emerging signals, and product risk profiles.
• Lead and develop Pharmacovigilance staff and provide functional direction, coaching, and oversight to external service providers and CRO partners.
• Own vendor governance, including service delivery, performance management, compliance, and issue escalation.
• Lead inspection and audit readiness for Pharmacovigilance activities, including investigation, remediation, and CAPA oversight.
• Oversee business partner relationships, including attendance at Joint Steering Committee meetings and construction of Pharmacovigilance Agreements.

Oversee medical review of aggregate safety data in standardized regulatory reports, including Investigator Brochures, Development Safety Update Reports, Periodic Benefit-Risk Evaluation Reports, and Periodic Safety Update Reports, to ensure a balanced, medically sound presentation and timely identification of potential product risks. Annual review of Risks section of all Rigel product Informed Consents.

Oversee medical review of Individual Case Safety Reports (ICSRs), including causality, seriousness, expectedness, coding quality, narratives, and case-series evaluations, ensuring appropriate medical judgment and regulatory compliance.

Oversee preparation, review, and timely submission of expedited and periodic safety reports, aggregate reports, and safety content for protocols, clinical study reports, and regulatory submissions.

Direct the set-up of new safety projects, including study-specific Safety Management Plans and 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 oncology safety considerations

Strategic Department Operations & Policy Development

• Lead departmental operations, including procedural strategies, training programs, service-provider management, inspection readiness, and audit support.
• Establish and maintain departmental policies, business strategies, and procedural compliance with corporate requirements and global pharmacovigilance regulations.

Cross-Functional Leadership & Stakeholder Management

• Serve as the primary Pharmacovigilance liaison with therapeutic leads, Drug Safety physicians, biostatisticians, and other key stakeholders on critical programs and safety matters.
• Represent Pharmacovigilance in cross-functional and senior leadership forums, providing strategic guidance on complex safety, benefit-risk, and regulatory 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 required; active U.S. medical license preferred.
• Minimum 10 years of progressive drug safety and pharmacovigilance experience in the biopharmaceutical industry.
• Minimum 4 years in leadership roles with drug safety team-management and/or functional-leadership 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
• Demonstrated experience interfacing with regulatory authorities on safety matters and leading inspection or audit readiness activities.
• Previous biotech/pharmaceutical industry experience with marketed products, as well as demonstrated ability to lead and develop staff and external safety partners.

COMPENSATION AND BENEFITS:

The anticipated salary range for this position is $265,000 to $310,000. 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.

WORKING CONDITIONS:

• PHYSICAL DEMANDS: While performing the duties of this job, the employee is required to stand, walk; sit; talk and hear. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus.
• WORK ENVIRONMENT: The noise level in the work environment is usually moderate. Some travel may be required.

Rigel Pharmaceuticals, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.