POSITION SUMMARY:
The Vice President, Translational Medicine & Clinical Pharmacology is a senior scientific leader responsible for integrating translational medicine, clinical pharmacology, drug metabolism/pharmacokinetics, bioanalytical, toxicology and pharmacodynamic / biomarker strategy across Rigel's portfolio. Reporting to the Chief Medical Officer, this role provides strategic and functional leadership from development candidate selection and IND-enabling activities through clinical development, regulatory submission, and life-cycle management. The Vice President will connect preclinical and clinical data to inform program strategy, dose and schedule selection, patient selection, proof-of-mechanism and proof-of-concept decisions, and the overall probability of technical and regulatory success.
Salary Range:$306,000 to $365,000
Employees designated as onsite or hybrid are expected to be onsite at Rigel’s South San Francisco headquarters during business hours on Wednesdays and Thursdays each week. Employees designated as remote are not subject to the weekly onsite requirement but are expected to be onsite at least quarterly and as business needs require.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Define and lead an integrated translational medicine and clinical pharmacology strategy across the portfolio, aligning scientific plans with clinical development, regulatory, and corporate objectives.
- Lead clinical pharmacology strategy and development plans for Rigel assets, including ADME, drug-drug interactions (DDIs), pharmacokinetics/pharmacodynamics (PK/PD), exposure-response, bioavailability/bioequivalence, and other studies required to characterize dose, regimen, safety, and efficacy.
- Oversee drug metabolism, pharmacokinetics, bioanalysis, and related DMPK activities supporting drug discovery, development candidate nomination, IND-enabling development, clinical programs, and regulatory filings.
- Integrate translational and quantitative pharmacology approaches, including population PK, PK/PD, pharmacometrics, modeling and simulation, to inform first-in-human strategy, dose escalation, dose optimization, go/no-go decisions, and late-stage dose justification.
- Develop and oversee translational and biomarker strategies, including target-engagement, pharmacodynamic, predictive, prognostic, and safety biomarkers, to support indication selection, patient enrichment, mechanism-based endpoints, and clinical proof-of-concept.
- Partner with Research, Clinical Development, Clinical Operations, Biostatistics/Data Science, Regulatory Affairs, Pharmacovigilance, CMC, Project Management, and other functions to translate preclinical biology and pharmacology into executable clinical development strategies.
- Provide scientific leadership for translational medicine and clinical pharmacology content in study protocols, Investigator Brochures, clinical study reports, INDs/CTAs, NDAs/BLAs/MAAs, briefing documents, responses to health authority questions, scientific presentations and abstract/manuscript writing.
- Represent the function in interactions with FDA and other global health authorities and ensure that development strategies reflect current regulatory guidance and scientific standards in clinical pharmacology and translational medicine.
- Evaluate, select, and manage external consultants, bioanalytical laboratories, biomarker laboratories, and academic collaborators; ensure scientific quality, timely execution, budget accountability, and appropriate GxP compliance.
- Build, lead, and develop a high-performing team; establish functional capabilities, resource plans, budgets, operating standards, and priorities appropriate to Rigel's portfolio and stage of development.
- Serve as a senior scientific contributor to program governance, portfolio review, business development diligence, and external scientific engagement, clearly communicating complex data and recommendations to executive and cross-functional stakeholders.
KNOWLEDGE AND SKILL REQUIREMENTS:
- Advanced scientific degree (PhD, PharmD, MD, or equivalent) in pharmacology, pharmaceutical sciences, drug metabolism, toxicology, translational medicine, or a related discipline; PhD or PharmD strongly preferred for a clinical pharmacology-focused role.
- Typically 15+ years of progressive biopharmaceutical industry experience in drug development, translational medicine, DMPK and/or clinical pharmacology, including substantial senior leadership and people-management responsibility.
- Deep expertise in clinical pharmacology, pharmacokinetics, pharmacodynamics, drug metabolism/ADME, bioanalysis, DDIs, exposure-response relationships, and quantitative approaches to dose selection and optimization.
- Demonstrated experience integrating preclinical pharmacology, translational biomarkers, PK/PD, and clinical data to advance programs from candidate selection and IND through proof-of-concept and later-stage development.
- Strong understanding of biomarker strategy and assay development, including target-engagement, pharmacodynamic, predictive, prognostic, and safety biomarkers; experience with patient-selection or precision-medicine approaches is preferred.
- Extensive experience preparing and supporting regulatory submissions and health authority interactions, including INDs/CTAs and marketing applications; strong working knowledge of FDA, ICH, GLP, and GCP requirements.
- Demonstrated ability to build and lead scientific teams, manage budgets and external partners, and deliver high-quality work on schedule while maintaining scientific rigor and compliance.
- Strong cross-functional leadership, judgment, and executive communication skills, with the ability to influence decisions in a matrixed environment and translate complex scientific information into clear development recommendations.
COMPENSATION AND BENEFITS:
The anticipated salary range for this position is $306,000 to $365,000. 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.