Senior Medical Director
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Job Location:
South San Francisco, CA - USA
Monthly Salary:
$ 363900 - 394000
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
PURPOSE OF JOB: The Senior Medical Director reports to the VP of Clinical Development and will initially be responsible for planning and implementing the clinical strategy for RPT904 an extended half-life anti-IgE monoclonal antibody in chronic spontaneous urticaria. This physician-scientist will serve as the subject-matter expert and medical lead in this therapeutic area to provide clinical and drug development expertise to the cross functional team. The role includes serving as the medical lead responsible for the execution and reporting of Phase II/III clinical studies as well as supporting the regulatory and commercial/medical affairs strategies in alignment with the overall development strategy.
MAJOR DUTIES AND RESPONSIBILITIES:
Serve as Clinical Development Lead in Chronic Spontaneous Urticaria eg:
- Provide strategic and design input for clinical trials and clinical development plans
- Participate in/and or lead preparation design and/or review of clinical documents e.g. protocols investigators brochures DSUR
- Contribute to clinical sections of relevant regulatory filings (IND study reports NDA PIP briefing packages etc.)
- Represent the company at scientific meetings and presentations
- Develop and maintain collaborative relationships with key opinion leaders for clinical programs
- Contribute to the medical affairs strategy through the development of the publication plan including authoring and / or reviewing abstracts presentations and manuscripts for medical accuracy and content
- Represent RAPT and provide medical support during investigator and consultant meetings (e.g. investigator meetings clinical advisory boards)
- Oversee internal clinical development team members and be responsible for clinical trials (e.g. Sponsor medical monitors clinical scientists) to ensure patient safety and data integrity
EDUCATION REQUIREMENTS:
- M.D. or M.D./Ph.D. with board certification in Allergy and Immunology or Dermatology or related field required
EXPERIENCE REQUIREMENTS:
- Minimum of 8 years mid-to-late stage (Phase II/III/IV) global clinical trial experience in pharmaceutical or biotech industries preferred or equivalent academic and clinical experience
- Clinical development or clinical practice experience in the field of Allergy/Immunology or Dermatology preferred.
- Experience with successful Health Authority (eg FDA EMA PMDA) interactions (eg NDA EOP2 Scientific Advice)
- Minimum of 2 years experience managing a team
- Be well connected within the medical and scientific community and have a proven successful track record
- Hands-on experience with clinical trial strategy methods and designs
- Ability to work proactively and effectively with exceptional creative problem-solving skills
- Excellent strategic planning organizational and communication skills
- Up to 20% travel
Required Experience:
Director
Key Skills
- EMR Systems
- Post Residency Experience
- Occupational Health Experience
- Clinical Research
- Managed Care
- Primary Care Experience
- Medical Management
- Utilization Management
- Clinical Development
- Clinical Trials
- Leadership Experience
- Medicare
About Company
RAPT Therapeutics is a clinical-stage biopharmaceutical company driven by our mission to treat inflammatory and immunologic diseases. Our cutting-edge science is fully focused on developing therapeutics that intelligently target key drivers of the immune system to transform the treatm ... View more
