Company Overview:

Otsuka is a global healthcare company driven by our purpose “to defy limitation, so

that others can too.” Patients are at the center of our purpose as we seek to discover and deliver innovative healthcare solutions. Otsuka is a leader in the CNS therapeutic area (TA), which is comprised

of a strong portfolio of individual development and marketed assets. As we continue to develop innovative medicines for those with CNS disorders, we are seeking a skilled and experienced Medical Director of CNS Early Assets, Global Medical Affairs, responsible for certain assets within the broader CNS TA portfolio Medical Affairs (both US and Global), with a specialization in Psychiatry and/or Neurology. Accountable for a subset of assigned assets within the CNS TA which align to the broader overall TA strategy determined by the Sr. Director, Franchise Lead CNS Early Assets.

Position Summary:

The Medical Director, Global Medical Affairs, CNS Early Assets will be responsible for supporting and executing the strategic vision for a select group of assigned assets within our CNS TA (encompassing Psychiatry and emerging Neurology portfolio). This role will report to the Sr. Director, Global Medical Affairs, Franchise Lead CNS Early Assets. Assets under this person’s responsibilities may include treatments for several serious illnesses with unmet needs in various stages of early development. This role will involve collaborating with cross-functional teams, key opinion leaders (KOLs), and stakeholders to ensure the successful implementation of asset level medical affairs strategies and tactics, ultimately driving the development and commercialization of treatments in the CNS space. The position consists of both US and Global Medical TA and asset level strategies and plans.

Key Responsibilities:

• Align to the therapeutic strategy, support the strategic vision for the respective assigned assets or TA portfolio.
• Contribute to the development and execute the medical strategic plans and initiatives for assigned assets based on unmet needs and medical value proposition that is aligned with and compliments the overall TA strategy.
• May represent Medical Affairs at certain US and Global governance meetings. The Director will work closely with other US and Global franchise or asset specific cross functional leads and will pull through the CNS TA strategy.
• Ensure insights into and contribute to the development and optimization of TRPPs (target reimbursable product profiles) for any assigned assets in development.

• Support lifecycle management initiatives and planning for assigned assets as applicable.

• Stakeholder engagement: Establish and maintain strong relationships with key opinion leaders, academic institutions, and medical/advocacy societies within the assigned disease areas within the CNS TA.
• Act as a company representative and advocate in relevant medical and scientific communities for specific assigned areas within the TA.
• Engages with a network of international scientific leaders and other key stakeholders (therapeutic guideline committees, payers, public groups, government officials, medical societies) about Our Company’s emerging science.
• Ensure peer relations within Otsuka across functions at appropriate leadership levels (Clin Dev, Translational Medicine, Global and US Marketing, Global Value and Real-World Evidence, etc.).

• Scientific and Medical Affairs Expertise: Experienced in US and global healthcare landscape for assigned areas. Knowledge and strong competency with the US healthcare system and regulatory landscape is required for this role.
• Stay abreast of the latest advancements, research, and publications within the assigned disease areas in psychiatry and neurology. Act as a subject matter expert, providing medical and scientific insights to internal teams and external stakeholders.
• Be up to date on latest evolutions in Medical Affairs trends and help franchise and department to continuously adapt and stay ahead.

• Cross-Functional Collaboration: Collaborate closely with other key functions, including regional medical leads, clinical development, global value and real-world evidence, US and global commercial teams, market access, and regulatory affairs, to ensure integrated global strategies and cohesive medical affairs strategies and input into cross functional leadership meetings and plans.

Requirements:

• Medical Doctor (MD), PhD or PharmD candidates with demonstrated experience in CNS Psychiatry or Neurology (preferably neuroinflammatory) conditions.
• Must have US Medical Affairs experience in addition to Global Medical Affairs experience (preferred) and knowledge of applicable US regulations.
• Relevant experience in translational medicine (T0 – T1) or early development (phase 1) assets either within Medical Affairs, Regulatory Affairs, or Clinical Development is preferred.
• Minimum of 7+ years of relevant experience in the pharmaceutical industry or biotechnology setting. Product launch experience preferred, especially in US.
• Clinical or academic practice in CNS preferred.
• Strategic mindset with the ability to translate insights into actionable plans.
• Strong communication and presentation skills, with the ability to interact effectively with internal and external stakeholders, including KOLs.
• Ability to work in a fast-paced, dynamic environment, with a proactive and problem-solving mindset.