
Medical Director, Global Strategy Lead Rare Diseases - ALS
Otsuka Pharmaceutical Co., Princeton, NJ, US, 08540
Duration: Full Time
Job Summary
The Medical Director, Rare Disease is a critical role responsible for shaping the strategic processes and planning for assets in across phases of development within the Rare Disease portfolio.
This position manages the unique challenge of establishing an emerging portfolio, incorporating newly acquired assets, which requires significant scientific and strategic agility and a strong ability to balance competing priorities. This position reports directly to the Rare Disease Medical Business Unit (BU) Lead.
Job Description
Key Responsibilities Include:
Medical Strategy & Narrative
- Provide key medical input into the initial development of the Target Reimbursable Product Profile as well as early development plans ensuring scientific consistency and alignment across functions (e.g., R&D, Clinical, Global Medical Affairs)
- Provide high-quality scientific/clinical input and review of early asset plans, ensuring content aligns with the overarching Medical Narrative
- Lead and nurture strategic partnerships with stakeholders by ensuring clear, consistent communication and aligning initiatives with partner priorities to strengthen collaboration and drive shared success in the rare disease space
- Serve as a primary scientific resource, providing guidance on the disease state and mechanism of action for the Rare Disease portfolio helping to translate science into value for patients and stakeholders
- Lead the Strategy and Tactical Planning Process, identifying critical data needs for the emerging portfolio
Evidence Generation Process
- Oversee the Medical Evidence Generation Process in partnership with GIE&I, translating strategic data gaps into clear research priorities and providing expert input into the design and feasibility of innovative clinical trials and data generation initiatives
- Support the planning and execution of Medical Affairs evidence generation activities relevant to the Rare Disease portfolio
External Stakeholder Engagement
- Identify and engage a wide variety of stakeholders, including KOL experts and patient advocacy groups to support collection, curation and communication of clinical Medical and methodological insights to inform understanding of unmet medical needs, emerging standard of care and development opportunities
- Develop Key Intelligence Topics & Questions (KITs/KIQs) for relevant assets, serving as the blueprint for insight collection from Key Opinion Leaders
- Lead the strategic planning, content development, and successful facilitation of consulting activities including Advisory Boards, ensuring objectives align with data gap analyses and asset/portfolio strategy
- Lead scientific exchange with key opinion leaders (KOLs) to gather insights and validate development hypotheses
- Support the development of scientific publications, abstracts, and presentations related to the Rare Disease portfolio
Cross-functional Integration & Planning
- Collaborate within the Rare Disease Medical Business Unit with the Rare Disease Medical Communications and Field Medical Affairs sub-teams
- Partner with and serve as a scientific and clinical resource for cross-functional colleagues including Clinical Development, Global Integrated Evidence & Innovation, Regulatory and Global Marketing and Market Access
- Support indication prioritization and portfolio planning for early assets
- Manage assigned Rare Disease medical program budgets in partnership with the Rare Disease Medical BU lead, ensuring accurate forecasting, responsible resource utilization, and compliance with internal policies and external regulations
- Consider technology and AI to support workflow improvement
Qualifications
Education and Experience:
- Advanced scientific degree is required (PharmD, MD, PhD, or equivalent) with extensive expertise in Rare Disease
- Minimum of 5+ years of relevant experience in the pharmaceutical industry, with strong preference for experience in Clinical Development, Research, or Medical Affairs
- Experience supporting BD evaluations for potential acquisitions
- Experience contributing to the integration and strategic planning for newly acquired or in-licensed assets
- Proven experience managing Evidence Generation processes and executing scientific Advisory Boards
Skills and Competencies:
- Strong leadership presence and ability to present to executive leadership team
- Skilled in cultivating strong relationships with global medical partners through proactive communication and strategic prioritization
- Motivated and solution-oriented with the ability to work collaboratively across the organization, particularly with R&D and Clinical teams
- Strategic agility required to build and adapt scientific strategy for an emerging portfolio
- Excellent communication and interpersonal skills, including experience presenting complex development strategies to large internal groups and engaging a limited number of highly specialized external experts
- Full understanding of rules and regulations in pharma, with the ability to apply knowledge of guidelines and regulations to early-stage Medical Affairs activities
- Ability to work in a fast-paced, dynamic environment, with a proactive and problem-solving mindset
- Strong understanding of drug development processes, especially early-stage development
- Openness to travel up to ~25% for 3 – 6 conferences in US and globally