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Role Summary
Global Medical Lead LC-FAOD
Responsibilities
Lead the Global Medical Sub Team (GMST), ensuring regional medical affairs are involved in and inform the development of global medical strategy
Develop and drive the timely execution of the Global Medical Plan for LC-FAOD and triheptanoin in the pre-launch, launch, and post-launch phases
Serve as the strategic medical leader on the Program Core Team and key sub-teams, shaping development, commercialization, and lifecycle strategies through deep scientific and clinical expertise. Work decisively to overcome challenges and drive program priorities forward
Lead advisory boards, steering committees, and investigator meetings to gather key insights that inform program strategy and activities
Lead updates to the Integrated Evidence Generation Plan (IEP), ensuring alignment with HEOR and clinical development to address global/regional evidence gaps
Lead and successfully complete global medical affairs data generation activities, including real-world evidence (RWE), investigator-sponsored trials (ISTs), and other strategic evidence initiatives
Accountable as the medical affairs lead for Disease Monitoring Programs for LC-FAOD, providing strategic medical leadership on all aspects of the study and accountable for leading data generation and publication activities aligned to the IEP
Provide deep disease area and product expertise, ensuring accurate and consistent communication of clinical and scientific data
Lead global publication strategy and congress planning activities, ensuring timely, high-impact dissemination of data and other education initiatives
Lead training and provide strategic guidance and tools toregional medical affairs teams to ensure launch readiness and consistent scientific exchange
Build and maintain relationships with global key opinion leaders, societies, and advocacy groups to inform strategy and amplify scientific reach
Accountable for the medical assessment of the competitor environment and providing direction on strategic implications
Collaborate effectively across the business e.g. clinical development, HEOR, diagnostics, scientific communications and publications, regulatory, market access, commercial, training, and patient advocacy
Qualifications
Medical Doctor (MD, PhD strongly preferred) with Board Certification in Clinical/Biochemical Genetics
Proven expertise in the management of patients with inborn errors of metabolism, preferably mitochondrial disease
Recognized scientific authority with the ability to engage in advanced scientific and clinical discussions with both internal and external experts
Proven leadership skills including a passion for collaboration and understanding all stakeholder perspectives to drive alignment and decision-making
High aptitude for attention to detail, commitment to high-quality work, and a sense of passion and urgency to achieve goals and improve the lives of patients
Proven ability to take initiative and drive successful execution of complex projects
Highly analytical and strategic thinker with the ability to identify interdependencies, consider medical implications, and understand the broader goals of a program and the organization
Excellent communication skills, with the ability to effectively articulate scientific and strategic concepts in both written documents and verbal presentations
Demonstrated success leading cross functional or multidisciplinary teams, ideally in both academia and biotech
Willingness and ability to travel up to 15%, including domestic and international engagements
Education
Medical Doctor (MD) or PhD with Board Certification in Clinical/Biochemical Genetics