Medical Director, PH-ILD (Europe)
Medical Director, PH-ILD (Europe)
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Job Description
Summary:
The Medical Director PH-ILD Europe serves as a strategic medical and scientific expert within the organization responsible for shaping and executing medical affairs strategies that drive therapeutic value scientific leadership and enrolment in clinical trials. This role provides medical expertise across key medical affairs activities including healthcare professional engagement evidence generation (clinical and real-world) scientific communication medical education and support of safe and appropriate product use. The Medical Director partners closely with cross-functional teams including Commercial Market Access Regulatory Safety and Clinical Development to support the development of Seralutinib in pulmonary hypertension associated with interstitial lung disease.
Responsibilities:
- Provide strategic medical and scientific leadership for Seralutinib in PH-ILD supporting the development and execution of Medical Affairs plans.
- Serve as the medical lead for cross-functional product teams ensuring medical strategy alignment with brand objectives and unmet patient needs.
- Develop the clinical landscape for PH-ILD in Europe gain insights into the patient journey referral patterns treatment and diagnostic patterns and implement medical
- Drive medical evidence generation strategies including real-world evidence (RWE) observational research investigator-initiated studies (IIS) and medical affairs-sponsored studies aligned to strategic priorities.
- Support the dissemination of scientific data through publications congress presentations advisory boards and medical education programs.
- Provide medical review and approval of promotional and non-promotional materials ensuring scientific accuracy fair balance and compliance with regulatory and ethical standards.
- Assist in the development of scientifically accurate marketing materials medical education programs advisories and symposia. Assist with the scientific review development approval execution and communication of affiliate/area/global medical affairs-sponsored or supported clinical research activities.
- Partner with Commercial Market Access Clinical Operations Safety and Clinical Development teams to provide medical insights and support product development phase 3 clinical trials launch readiness and pre-market activities.
- Provide medical input into market access and health economics & outcomes research (HEOR) strategies including value propositions and payer engagement.
- Coordinate appropriate scientific and medical activities with internal stakeholders (i.e. commercial clinical operations discovery statistics regulatory etc.) as they relate to ongoing medical affairs projects. Serve as the scientific team interface for key regulatory discussions.
- Serve as a therapeutic area expert and resource for internal stakeholders and to the MSL team.
- Ensure budgets timelines and compliance requirements are factored into programs scientific activities.
Qualifications:
- Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D). Relevant therapeutic specialty in an academic or hospital environment preferred. Completion of residency and/or fellowship is preferred.
- In-depth understanding of the ILD landscape is a strong preference.
- Minimum of 2 years of medical affairs experience in the pharmaceutical industry or academia or equivalent. 5 years of experience is preferred.
- Ability to translate complex scientific information into clear concise and impactful medical and strategic guidance is preferred.
- Knowledge of clinical trial methodology data analysis and interpretation regulatory requirements governing clinical trials and experience in development strategy and the design of protocols.
- Proven leadership skills in a cross-functional global team environment.
- Ability to interact externally and internally to support global business strategy.
- Excellent oral and written English communication skills.
- This role reports through Gossamer Bio Dublin Ireland office and can be remote within Europe.
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Required Experience:
Director
Employment Type
Full Time
