Senior Director, Medical Affairs

Role Summary

Senior Director, Medical Affairs is responsible for leading the development of the Medical Affairs plan for leniolisib in activated PI3K delta syndrome (APDS), representing the US healthcare environment with internal teams and external customers involved in APDS research and patient treatment. This role requires deep subject matter expertise in APDS and immunology clinical trials, along with strong leadership skills. This is a fully remote opportunity.

Responsibilities

• Demonstrate deep subject matter expertise in APDS/immunology clinical trials, clinical use, pipeline, and competitive products.
• Develop strategies and implement plans to address unmet research and medical needs within US patient populations.
• Engage US customer segments, including traditional Opinion Leaders and healthcare professionals, integrated medical systems/hospitals, and formulary decision makers.
• Prepare presentation materials and present scientific data at internal meetings and external advisory boards.
• Serve as an information resource and trainer to Pharming colleagues, including medical education activities, grants, and investigator-sponsored/collaborative studies.
• Support data generation activities through critical review of phase 3b and phase 4 study proposals and Investigator-Initiated Trials (IITs).
• Review abstracts and/or manuscripts.
• Communicate Pharming’s commitment to scientific excellence through research and education.
• Provide medical and scientific leadership and support at key scientific meetings (US and international).
• Provide strategic input to Global/Regional Medical Affairs Plan and Life Cycle Team activities.
• Assist medical and scientific review of US promotional materials for submission to PRC, MRC, and SMGC.
• Engage in other activities as assigned to support rare disease Medical Affairs initiatives.

Qualifications

• Minimum: Advanced degree in a healthcare field; MD or PhD required.
• 8+ years’ experience in clinical practice and/or industry, with preference for immunology/rare disease/genetic diseases.

Preferred Qualifications

• Industry experience in Medical Affairs, Clinical Development, or Research; success in a similar role outside biotech/pharmaceutical industry preferred.
• Experience in product launch, regulatory filings, and FDA communications.
• Ability to cultivate and maintain relationships with internal and external customers.
• Strong leadership and management skills.
• Robust presentation and communication skills for professional and non-professional audiences; can provide succinct, strategic, actionable insights to senior leadership.
• Proactive self-starter who can lead workstreams independently.
• Experience managing multiple projects concurrently.
• Ability to work effectively in a remote environment.
• Commitment to Pharming’s mission, core values, and behaviors.

Skills

• Subject matter expertise in APDS/immunology clinical trials
• Strategic planning for medical affairs in US markets
• Medical education program development
• Scientific writing and presentation
• Cross-functional collaboration and stakeholder management

Education

• MD or PhD required; advanced healthcare degree.

Additional Requirements

• Travel up to 30% domestically and internationally.
• Remote work capability.