VP, Clinical Science & Drug Safety

Rigel Pharmaceuticals, Inc. South San Francisco , CA 94080

Posted 2 months ago

POSITION SUMMARY:

Reporting to the Chief Medical Officer (CMO), the VP, Clinical Sciences & Drug Safety manages the clinical development of drug candidates and oversees the pharmacovigilance (post-marketing) and drug safety (phase I-III) functions. The VP, Clinical Science and Drug Safety will have a strong understanding of all phases of pharmaceutical drug product development, including clinical trial management, NDA submissions, post-launch marketing, post-approval studies, regulatory affairs and GCP, including extensive collaboration with Clinical Operations, Medical Affairs and Regulatory Affairs and other key stakeholders.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Responsible for clinical programs and trial development process. Provide leadership for clinical strategy and oversight to ensure excellence in clinical trial conduct, data analysis and interpretation to enable regulatory filing activities.

  • Manage and mentor Senior and Executive Medical Directors

  • Accountable for quality and timely preparation of clinical sections of all relevant regulatory filings (BLA, Marketing Applications, IND, study reports, etc.)

  • Interact with key opinion leaders to assure latest clinical thinking and guidelines are incorporated into the clinical development plan

  • Serve as key medical and technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contract resources

  • Represent the company at scientific, commercial and financial community meetings and presentations, as well as other public relations opportunities

  • Attend and provide science support for investigator and consultant meetings and other study implementation workshops

  • Participate in management of studies and serve as expert on clinical and medical issues to other colleagues and study site staff

  • Provide oversight and leadership in the development of publications, abstracts, and presentations

  • Develop protocols to execute clinical development strategies and oversee drug safety, collaborating with Clinical Operations and Data Science Solutions

  • Work cooperatively with Clinical Operations and designated CROs to execute the programs (e.g. oversee or perform Medical Monitoring responsibilities; review safety monitoring plans; establish and/or coordinate use of consistent ICF safety language; perform initial data review studies; draft/present clinical slides for Investigators Meeting and therapeutic/monitor training; review draft CRFs, etc.)

  • Key contributor to life cycle management of all clinical programs

  • Assess project/program needs, plan for internal and external resources and act accordingly to ensure adequate and timely support

  • Assure the Clinical Sciences & Drug Safety department works closely with Research, Medical Affairs and Commercial as appropriate for effective execution of various programs (specifically, responsible for life cycle management, new studies, and compassionate-use program)

  • Oversee pharmacovigilance (post marketing) and drug safety (for clinical trials) functions including reporting and ensuring compliance to regulatory guidelines

  • Work with project team to initiate preclinical models to expand the respective clinical programs

KNOWLEDGE AND SKILL REQUIREMENTS:

  • M.D. with 10 years' industry experience, or comparable experience in the management and execution of phase II/III trials with credible compounds/established companies; additional PhD preferred

  • Proven leadership and management experience with 3-5 years' experience managing other clinicians; strong people management skills; willingness to help others be successful, act both at a strategic and execution level.

  • Board certified or eligible in either immunology, hematology or oncology preferred

  • Demonstrated ability to evaluate, interpret and present complex scientific data

  • Demonstrated ability to critically evaluate complex drug development programs

  • Demonstrated ability to work within a multi-disciplinary team of peers and outside experts

  • Excellent communication, presentation, and influencing skills within and cross-functionally; success influencing executives and senior level scientific management as well as external representation of company.

  • Outstanding leadership qualities, both technically as well as personally; passion for setting standards of excellence

  • Prior success working with/influencing cross functional teams including driving and holding team members to decisions/outcomes. Collaborative, team-focused, consistently looks for win-win solutions to problems

  • Flexibility to adjust, to change quickly; sound decision-making 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.

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VP, Clinical Science & Drug Safety

Rigel Pharmaceuticals, Inc.