Vice President, Clinical Development

at  Rigel Pharmaceutical

POSITION SUMMARY:

Reporting to the Chief Medical Officer (CMO), the Vice President, Clinical Development manages the clinical development of drug candidates, creating integrated clinical development strategies and plans reflecting specific needs for registration and commercial success. The Vice President, Clinical Development will have a deep understanding of all phases of pharmaceutical drug product development, regulatory experience and will collaborate efficiently with other key stakeholders (Biometrics, Research, Medical Affairs, Regulatory Affairs, etc), providing strategic and operational leadership to the clinical project teams.

QUALIFICATIONS:

• M.D. degree; advanced knowledge in hematology/oncology required. Board certification in hematology or oncology preferred
• Minimum of 8 years experience in clinical research or drug development (Phase 1 through 4) in an academic or industry environment; =6 years in an industry (pharmaceutical or biotech) setting
• Experience with health authorities
• Demonstrated ability to evaluate, interpret and present complex scientific data
• Thorough knowledge of Good Clinical Practice, statistics, trial design
• Proven leader in driving towards clinical solutions; has demonstrated leadership and management skills with a track record of delivering high quality outputs
• Significant experience working cross-functionally with a multi-disciplinary team of peers and establishing scientific partnerships with external experts
• Excellent communication (verbal and written) and presentation skills
• Rigel requires all employees to be vaccinated against COVID-19 (subject to any legally required exemptions)

• Lead the development and execution of the clinical program strategy, including formulation of clinical development plans
• Design, plan, execute, interpret and communicate clinical trials/research and results, according to appropriate medical/scientific and regulatory/quality standards, in close collaboration with the CMO.
• Support the creation/updates of clinical trial protocols/protocol amendments, Investigator’s Brochures, clinical study reports, statistical analysis plans, regulatory documents (e.g. registration dossiers, briefing books) with key internal stakeholders
• Lead interactions and create a network with external stakeholders, such as academic leaders/KOLs, safety/data monitoring committees, patient advocacy groups and manage advisory boards
• Support Business Development, due diligence and potential in-licensing activities
• Support pharmacovigilance (post marketing); perform safety monitoring of clinical studies, ensuring continuous evaluation of drug safety profile and compliance with regulatory guidelines (together with Drug Safety)
• Represent clinical development on the Project Teams
• Member of IST Review Committee
• Provide ad hoc support for Medical Affairs scientific publications
• Work cooperatively with Clinical Operations and designated CROs to execute the clinical programs (e.g. oversee or perform Medical Monitoring responsibilities; review safety monitoring plans; establish and/or coordinate use of consistent ICF safety language; perform routine data review; chair Investigators meetings, perform training where needed; review draft CRFs, etc.)
• Manages, forecasts and allocates resources for the clinical program with the support of the Head of Clinical Operations and Finance.
• Collaborate with Research, Regulatory Affairs and Medical Affairs as appropriate for effective execution of various programs (specifically, responsible for life cycle management, new studies, and compassionate-use programs)