Senior Director, Medical Affairs
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Job Location:
South San Francisco, CA - USA
Monthly Salary:
$ 303800 - 335700
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
PURPOSE OF JOB:
The Senior Director Medical Affairs is a foundational leadership role responsible for building the Medical Affairs function and developing the integrated medical strategy for RAPT Therapeutics pipeline. This role reports into the VP of Commercial and Medical Affairs. This role operates with a high degree of autonomy and strategic independence receiving general direction from senior leadership and the cross-functional team. The main responsibilities include establishing medical affairs processes leading evidence generation driving scientific exchange and providing medical expertise to cross-functional teams to support the development and commercialization of assets with an initial focus on RPT904.
MAJOR DUTIES AND RESPONSIBILITIES:
- Develop and lead the integrated Global Medical Affairs strategy for the companys pipeline.
- Serve as the primary Medical Affairs representative on cross-functional teams (Clinical Development Commercial Regulatory Market Access).
- Build the Medical Affairs function from the ground up including establishing processes SOPs and budget management.
- Conceive and lead the Integrated Evidence Generation Plan (IEGP) including Phase 3b/4 trials Real-World Evidence (RWE) studies and Investigator-Sponsored Research (ISR).
- Provide medical and scientific input into the design of late-stage clinical trials and collaborate on data analysis and interpretation.
- Establish and nurture relationships with global Key Opinion Leaders (KOLs) academic institutions and patient advocacy groups.
- Oversee the development and execution of the global Medical Communication and medical education strategy.
- Provide strategic medical guidance to Commercial Health Economics and Outcomes Research and Market Access teams to support the product value story and evidence needs for payers.
- Represents the company and its science at major international congresses.
- Makes decisions that have a significant impact on the department and the business.
- Interfaces with senior-level internal and external personnel.
- Develops strong internal and external collaborative relationships.
EDUCATION REQUIREMENTS:
- PhD or PharmD from an accredited institution is required. MD or DO is desired.
- A PhD in Immunology or a closely related field is also highly valued.
EXPERIENCE REQUIREMENTS:
- A minimum of 12 years of progressive experience in Medical Affairs within the biopharmaceutical industry.
- A minimum of 5 years experience directly managing employees.
- Direct experience leading the Medical Affairs strategy for a product from Phase 3 through to and including launch.
- Proven track record of building and executing Integrated Evidence Generation Plans that include Phase 4 and RWE studies.
- Deep and established relationships with KOLs in the allergy/immunology and/or dermatology communities.
- Expert knowledge of global regulatory requirements (FDA EMA) GCP and industry compliance guidelines.
- Comprehensive understanding of pharmaceutical product development lifecycle management and commercialization processes.
- Proven ability to lead and influence in a matrixed environment.
- Thorough knowledge of the healthcare systems in the US and EU.
OTHER QUALIFICATIONS:
- Demonstrated focus on inflammation and immunology specifically allergic diseases (e.g. food allergies atopic dermatitis urticaria) is highly desirable.
- Experience building or significantly scaling a Medical Affairs function in a small-to-mid-sized biotech company is highly desirable.
- Strategic agility with the ability to think critically and develop a long-term vision.
- Deep scientific acumen in the clinical landscape for inflammation.
- Patient-centricity with a genuine understanding of the burden and unmet needs faced by patients.
- Exceptional influential communication and presentation skills.
- Entrepreneurial self-starter mindset comfortable with ambiguity and a fast-paced environment.
- A collaborative and team-oriented approach to leadership.
Required Experience:
Exec
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
