Senior Director, Medical Affairs

Role Summary

The Senior Director, Medical Affairs is a foundational leadership role responsible for building the Medical Affairs function and developing the integrated medical strategy for the company’s pipeline. This role reports into the VP of Commercial and Medical Affairs, operates with a high degree of autonomy, and focuses on establishing medical affairs processes, leading evidence generation, driving scientific exchange, and providing medical expertise to cross-functional teams to support development and commercialization, with an initial focus on RPT904.

Responsibilities

• Develop and lead the integrated Global Medical Affairs strategy for the company's 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.
• Represent 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.

Qualifications

• Required: A minimum of 12 years of progressive experience in Medical Affairs within the biopharmaceutical industry.
• Required: A minimum of 5 years‚Äô experience directly managing employees.
• Required: Direct experience leading the Medical Affairs strategy for a product from Phase 3 through to and including launch.
• Required: Proven track record of building and executing Integrated Evidence Generation Plans that include Phase 4 and RWE studies.
• Required: Deep and established relationships with KOLs in the allergy/immunology and/or dermatology communities.
• Required: Expert knowledge of global regulatory requirements (FDA, EMA), GCP, and industry compliance guidelines.
• Required: Comprehensive understanding of pharmaceutical product development, lifecycle management, and commercialization processes.
• Required: Proven ability to lead and influence in a matrixed environment.
• Required: Thorough knowledge of the healthcare systems in the US and EU.

Education

• Required: PhD or PharmD from an accredited institution. MD or DO is desired.
• Desirable: PhD in Immunology or a closely related field.

Skills

• Demonstrated focus on inflammation and immunology, specifically allergic diseases, 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 an understanding of patient burden and unmet needs.
• 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.

Additional Requirements

• None specified.