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.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Lead the development and execution of the clinical program strategy, including formulation of clinical development plansDesign, 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 stakeholdersLead 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 activitiesSupport 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 TeamsMember of IST Review CommitteeProvide ad hoc support for Medical Affairs scientific publicationsWork 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)

QUALIFICATIONS: 

M.D. degree; advanced knowledge in hematology/oncology required. Board certification in hematology or oncology preferredMinimum 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) settingExperience with health authoritiesDemonstrated ability to evaluate, interpret and present complex scientific data Thorough knowledge of Good Clinical Practice, statistics, trial designProven leader in driving towards clinical solutions; has demonstrated leadership and management skills with a track record of delivering high quality outputsSignificant 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)

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.