Senior Medical Director – Rigel Pharmaceutical – South San Francisco, CA

POSITION SUMMARY:
Reporting to the VP, Clinical Science & Drug Safety, the Senior Medical Director manages the clinical development of drug candidates including phase I-IV studies and across multiple therapeutic areas. The successful candidate will have a strong understanding of pharmaceutical drug product development including clinical trial management, IND and NDA submissions, medical monitoring and GCP principles. In addition, this individual will have extensive experience collaborating with Clinical Operations, Research and Clinical Pharmacology, Regulatory Affairs, Publication Planning and other key stakeholders. The Senior Medical Director may work closely with Medical Affairs in review of investigator-initiated and post-approval studies. This role will combine strategic capability with hands on execution.

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ESSENTIAL DUTIES AND RESPONSIBILITIES*:

• Develop protocols to execute clinical development strategies
• Work cooperatively with Clinical Operations and designated CROs to execute the programs (e.g. lead study start up and database lock medical monitoring activities; address medical monitor inquiries from sites or Operations; perform data and coding reviews; draft/present clinical slides for Investigators Meeting, Advisory Boards and therapeutic/monitor training; review draft CRFs, etc.)
• Participate as a key member in portfolio management and clinical program planning
• Ensure that the Clinical Science department works closely with Research and Clinical Pharmacology, Medical Affairs and Regulatory as appropriate for effective execution of various programs
• Work with academic leaders/advisers to develop clinical strategy
• Write/edit clinical reports, investigator brochures and clinical aspects of Regulatory submissions; support all other Regulatory activities and NDA related questions
• Other duties commensurate with position as assigned
• Ability to travel may be required

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KNOWLEDGE AND SKILL REQUIREMENTS*:

• M.D. degree with a minimum of 5 years’ industry experience, or comparable experience in the management and execution of phase I or II-III trials with credible compounds/established companies
• Board certified or eligible in either immunology, inflammatory diseases, hematology or oncology
• Demonstrated ability to independently evaluate, interpret and present complex scientific data
• Demonstrated ability to critically evaluate complex drug development programs
• Medical monitoring experience
• Experience managing consultants and outside vendors
• Demonstrated ability to work cross functionally with a multi-disciplinary team of peers and outside experts
• Experience participating in FDA document preparation, ideally with FDA interaction
• Excellent communication (verbal and written) and presentation skills
• Results oriented, entrepreneurial and self-motivating
• Proactive and persistent
• “Hands-on” style with a strong sense of urgency, discipline and commitment
• Strong team player and team leader with excellent interpersonal skills and a focus on collaboration and teamwork
• Intellectual curiosity and energy, and a strong work ethic
• Innovative mindset with strategic capability and the ability to implement with strong attention to detail
• Ability to think ahead to identify issues related to successful achievement of the identified goals and objectives, and proactive in heading off problems before they occur
• Rigel requires all employees to be vaccinated against COVID-19 (subject to any legally required exemptions)

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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.

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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._*

Job Type: Full-time