Asia Pacific Solid Tumour Therapeutic Area Leader

**OVERALL PURPOSE OF THE JOB**:

- To develop an Asia Pacific (AP) Medical Strategy for the Solid Tumour Therapeutic Area (TA) in line with Global TA and Disease Area Strongholds and Regional Integrated Value Team (IVT) strategies, including the needs of AP markets and input from local thought leaders and the external scientific community
- To drive implementation of the AP Medical Affairs Plan by Medical Directors and Advisors, Medical Education Specialists and Coordinators, on time and within budget
- To co-lead the IVT to develop and drive a regional TA strategy, ensuring effective communications between key regional and global teams
- To represent AP MAF for the relevant TA at the Global level (GMAT, CDT, etc.), on strategic and tactical matters
- To support and guide New Business Development activities regarding opportunities for Licensing and Acquisition in the franchise

**CORE ACTIVITIES**:
**AP Medical Affairs Franchise Leadership**
- Represent AP MAF as the TA expert
- In partnership with co-lead(s) of IVT, develop and drive the TA strategy
- Represent the consolidated medical voice for AP markets in the TA
- Represent AP to regional and global teams for building the TA and brand strategy and provide input into the development plans of products included in the TA
- Develop and maintain expertise in products, market trends, competitor’s activities, etc.
- Build and maintain a network with key external thought leaders to ensure clear understanding of external thinking and to ensure the Company medical strategy reflects the external environment
- Provide scientific leadership for Medical Directors / Advisors, Medical Education Specialists and Coordinators and other AP functions in the TA
- Be accountable for the execution of the AP Medical Plan and budget for regional activities for the TA and brands
- Provide support to the AP Medical TA team to deliver the AP MAF Strategy and Plan:

- Work with the Medical Directors/Advisors and Medical Education Specialists to gather input for the AP Medical Affairs Plan(s) for designated product(s)
- Approve the AP Medical Affairs Plan for allocated product(s)
- Work with the TA teams in AP to proactively identify and provide medical input into opportunities for new indications or lifecycle extensions for allocated product(s)
- Work with the other functions to develop approaches to support successful market access for allocated product(s) in partnership with Health Economics, the CDT (Compound Development Team) and lifecycle management teams
- Leverage product(s) expertise, medical and market insight to shape and direct implementation of product(s) strategies and plans
- Ensure effective and regular communications between Global, Regional and local MAF teams, including regular communications to help minimise duplication of clinical, advocacy and access programmes across countries, and facilitate co-ordination between AP Medical Affairs, CDT, Strategic Marketing, Health Economics and the individual countries in AP
- A member of the GMAT:

- To represent the unified AP voice for the TA
- To shape AP MAF Strategy for the TA
- To ensure timely and reliable input from AP into the Compound Development Team (CDT), including input into phase II/III study designs, and country and site selection for the respective TA
- To ensure input into the Global Clinical Program with the aim to have representation from appropriate AP countries
- To provide input on breakthrough research in line with the unmet medical/social needs in AP region
- Accountable for line management of AP Directors / Medical Advisors, and dotted line for Medical Education Specialists and Coordinators
- Allocation of responsibilities for product ownership and other activities
- Clear articulation of goals and objective setting
- Performance management and performance evaluation
- Additional coaching and feedback for direct reports as required
- Development plans and requisite training
- A core member of the AP Medical Affairs Leadership Team

**External Relationships**
- To maintain and leverage relationships with experts and other important stakeholders related to the activities in the TA to gain input into the development of the product strategy, to specific protocols, and to services ensuring high-quality patient care

**Product Safety and Regulatory Requirements**
- As per the J&J guidance and SOPs:

- Ensure that medical Directors/Advisors manage product-related medical safety issues and provide input to AP Pharmacovigilance & Medical Compliance, Janssen AP Medical Affairs and Global Safety Management Teams (SMTs)
- Work with Regulatory Affairs & Product Issue Management Team to coordinate and manage product-related issues and support major quality incidents / recalls throughout Janssen AP
- Escalate issues and enquiries to VP MAF AP Region as appropriate
- Ensure adequate clinical input is provided to Company Core Data Sheet and Patient Information by the MAF Director / Advisor update process and wher