Executive Director, Clinical Development

POSITION SUMMARY:

The Executive Director, Clinical Development leads the clinical and medical work for assigned hematology and oncology programs, reporting to Vice President, Clinical Development. This role develops program recommendations, translates approved strategies into study plans, and provides hands-on medical leadership from study design through data interpretation and reporting. The Executive Director works within agreed program priorities and budgets, bringing significant benefit-risk findings, changes in development direction, and resource needs to the Vice President for review.

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 expected to be onsite during business hours on Wednesdays and Thursdays at least twice per month, and more frequently as business needs require.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Develop clinical development plans for assigned assets, defining the patient population, treatment rationale, endpoints, and evidence needed to support development milestones; recommend options to the Vice President.
• Lead protocol and amendment development, including eligibility criteria, dose selection, stopping rules, and assessment schedules, with input from Biometrics, Clinical Operations, Drug Safety, and Translational Medicine.
• Serve as the medical lead or medical monitor for assigned trials. Address investigator questions, review eligibility and protocol deviations, and support consistent clinical decisions across sites.
• Review emerging safety and efficacy data with Drug Safety and Biometrics; evaluate clinical relevance, identify concerns promptly, and recommend appropriate study actions through established review processes.
• Guide medical review of study data, including case narratives, response assessments, and clinically significant discrepancies; support database readiness and accurate interpretation of results.
• Partner with Clinical Operations and CRO medical teams to resolve issues affecting patient care, enrollment, data quality, and timelines. Provide clinical input to risk mitigation and vendor performance discussions.
• Lead or review the clinical content of Investigator's Brochures, clinical study reports, briefing materials, and submission documents; ensure that conclusions accurately reflect available evidence.
• Contribute to health authority preparation and responses with Regulatory Affairs; present clinical analyses at meetings when delegated by the Vice President.
• Build relationships with investigators and external clinical experts; gather practical feedback on study feasibility and clinical relevance, and support investigator meetings and scientific advisory discussions.
• Present program findings and recommendations to internal teams. Escalate material safety issues, milestone risks, and proposed changes in scope, budget, or strategy to the Vice President.
• Draft and/or provide clinical input to publications, scientific presentations, lifecycle planning, and selected business development assessments in coordination with the responsible functions.
• Mentor clinical colleagues, oversee CRA training and oversee assigned clinical deliverables. Supervise staff or consultants when assigned and contribute to their development and performance feedback.
• Apply GCP, applicable requirements, and Rigel procedures to clinical activities; support inspection readiness, documentation quality, and timely resolution of identified issues.

KNOWLEDGE AND SKILL REQUIREMENTS:

• MD or equivalent medical degree with advanced knowledge of hematology and oncology. Board certification in hematology or oncology preferred.
• Typically at least 8 years of relevant clinical research or drug development experience, including at least 5 years in pharmaceutical or biotechnology clinical development; depth of program responsibility will be considered alongside years of experience.
• Experience independently leading clinical work for an oncology or hematology program, including protocol development, medical monitoring, data review, and interpretation of trial results.
• Working knowledge of early and later phase development, clinical trial methodology, statistical principles, and disease-specific response criteria; experience supporting regulatory submissions or health authority interactions preferred.
• Sound medical judgment and the ability to assess benefit-risk, prioritize patient safety, and communicate recommendations and unresolved questions clearly.
• Ability to lead matrix teams, collaborate with investigators and CRO partners, and manage competing program deliverables in a growing biotechnology organization.
• Strong scientific writing, presentation, and problem-solving skills; experience mentoring clinical scientists or physicians preferred.

COMPENSATION AND BENEFITS:

The anticipated salary range for this position is $285,000 to $335,000. 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.