Executive Medical Director, Ta Lead

**Purpose & Scope**:
The Executive Medical Director, TA Lead for MA International (MA-INT) is accountable for medical and scientific strategy across the assigned Therapeutic Area (TA) for products that are approved or in Phase 3 and targeted for the International Markets (INT-M) region. Responsible for ensuring medical strategy and tactics are in place for the Therapeutic Area as well as for the individual compounds in the portfolio.

Accountabilities include supervision of Medical Directors responsible for development and execution of an overall medical strategy for the individual products. Responsible for working closely with key stakeholders across the company to achieve business objectives for the INT-M Region through support of MA colleagues in the International affiliates.

**Essential Job Responsibilities:
Technical Experience and Clinical TA knowledge
- Has in-depth knowledge of TA and is considered an internal expert of the TA, diseases and products.
- Ensure the development of INT Region MA strategies to be included in the Core Medical Plans (CMP) (including HEOR activities and Phase 3b/4 studies) for products in the TA.
- Has a thorough understanding of the regulatory environment and is able to contribute to regulatory strategies internally and externally.
- Effective in communication of knowledge to major internal and external stakeholders.
- Represent the TA in medical activities at medical and scientific conferences.
- Build the reputation of Astellas as a centre of research excellence and a leader in research and treament of diseases in TA.
- Conduct late-stage scientific due diligence for in-license opportunities when requested. - Analyse, present and defend benefit/risk assessments for products in TA. Clinical Research
- Lead data gap analyses and drive strategy to fill gaps through the options available to MA.
- Review and critique effectively study protocols in the TA. Handle challenges in execution of studies proactively, being accountable for around 2-5 MA sponsored studies.
- Oversee planning and execution of data dissemination strategies and ensure alignment of all key stakeholders.

**Business Acumen and Strategic Thinking
- Provide external medical and business environment perspective and TA knowledge in the development of Core Medical Plans and the brand plans; and Phase 3 clinical development plans when requested.
- Has advanced understanding of pharmaceutical industry and role of MA; provides guidance and expertise within Astellas.
- Lead cross-functional teams effectively and identify and resolve conflicts within a complex matrix organization.
- Analyze, identify and proactively mitigate project, budget and timelines at risk and propose solutions before delays occur. - Build and maintain relationships with global experts and be able to obtain important key scientific insights to support the TA.
- Manages multiple projects with a high degree of efficiency. Legal/Compliance Skills - Proactively engage legal and/or Ethics & compliance for guidance on TA projects/initiatives and to monitor/investigate/audit issues.
- Provide professional guidance on MA projects (including HEOR activities) based on knowledge of company, industry, regulatory and legal environment.
- Act as Subject Matter Expert and Trusted Advisor to equip and enable personnel to understand and strictly adhere to the Astellas’ Code of Ethics and associated policies and procedures and other applicable laws and regulations. To include all relevant Standard Operating Procedures (SOPs) and relevant Ethics and Compliance (E&C) policies.
- Fully understand, comply with, and challenge as appropriate. Raise any concerns in a timely manner with the relevant manager(s) including reference to the E&C team and/or the EthicsPoint Hotline.
- Regularly undertake and refresh mandatory E&C training in order to maintain knowledge and expertise to enable informed consent and personal accountability.
- Be aware of, and comply with, the Astellas Way and Astellas Competences, in terms of expected values and behaviours, Astellas’ HR policies, procedures and guidelines.”

**Leadership
- Create a culture of “One Astellas” through effective leadership of matrix teams of global and functional colleagues assigned to products or TA to advance complex Products/TA Goals.
- Represent Astellas and may co-lead the Medical Plan creation with alliance partners companies, as required.
- Sought-out by key internal and external leaders for consultation on leading projects and initiatives that come from personal expertise and experience.
- In partnership with the International affiliate MA Heads and Operational Excellence, be accountable for ISRs.
- Serves as a key force in enhancing cohesion and effectiveness of Medical Affairs and HEOR by fostering cross team collaboration.
- Has direct management responsibilities for 1-3 medical/scientific reports.