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
Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.
Minimum $205,368.00 - Maximum $307,050.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
Application Deadline : This will be posted for a minimum of 5 business days.
Company benefits: Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka .
Disclaimer:
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
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