Medical Director, Global Strategy Lead Rare Diseases

3 weeks ago


Augusta, United States Maine Staffing Full time

Medical Director, Rare DiseaseThe Medical Director, Rare Disease is a critical role responsible for shaping the strategic processes and planning for assets 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.Key Responsibilities Include:Medical Strategy & NarrativeProvide 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 NarrativeLead 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 spaceServe 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 stakeholdersLead the Strategy and Tactical Planning Process, identifying critical data needs for the emerging portfolioEvidence Generation ProcessOversee 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 initiativesSupport the planning and execution of Medical Affairs evidence generation activities relevant to the Rare Disease portfolioExternal Stakeholder EngagementIdentify 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 opportunitiesDevelop Key Intelligence Topics & Questions (KITs/KIQs) for relevant assets, serving as the blueprint for insight collection from Key Opinion LeadersLead the strategic planning, content development, and successful facilitation of consulting activities including Advisory Boards, ensuring objectives align with data gap analyses and asset/portfolio strategyLead the scientific exchange with key opinion leaders (KOLs) to gather insights and validate development hypothesesSupport the development of scientific publications, abstracts, and presentations related to the Rare Disease portfolioCross-functional Integration & PlanningCollaborate within the Rare Disease Medical Business Unit with the Rare Disease Medical Communications and Field Medical Affairs sub-teamsPartner 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 AccessSupport indication prioritization and portfolio planning for early assetsManage 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 regulationsConsider technology and AI to support workflow improvementQualificationsEducation and Experience:Advanced scientific degree is required (PharmD, MD, PhD, or equivalent) with extensive expertise in Rare DiseaseMinimum of 5+ years of relevant experience in the pharmaceutical industry, with strong preference for experience in Clinical Development, Research, or Medical AffairsExperience supporting BD evaluations for potential acquisitionsExperience contributing to the integration and strategic planning for newly acquired or in-licensed assetsProven experience managing Evidence Generation processes and executing scientific Advisory BoardsSkills and Competencies:Strong leadership presence and ability to present to executive leadership teamSkilled in cultivating strong relationships with global medical partners through proactive communication and strategic prioritizationMotivated and solution-oriented with the ability to work collaboratively across the organization, particularly with R&D and Clinical teamsStrategic agility required to build and adapt scientific strategy for an emerging portfolioExcellent communication and interpersonal skills, including experience presenting complex development strategies to large internal groups and engaging a limited number of highly specialized external expertsFull understanding of rules and regulations in pharma, with the ability to apply knowledge of guidelines and regulations to early-stage Medical Affairs activitiesAbility to work in a fast-paced, dynamic environment, with a proactive and problem-solving mindsetStrong understanding of drug development processes, especially early-stage developmentOpenness to travel up to ~25% for 3 6 conferences in US and globallyCompetenciesAccountability 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.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).Statement Regarding Job Recruiting Fraud Scams: At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address


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