Asia Pacific Medical Director
4 days ago
In this role as the
- **Asia Pacific (AP) Oncology Medical Director, **you will develop the AP Medical Strategy and AP Medical Affairs Product Plan for assigned Lung cancer products and new indications in line with Global TA/Disease Area Stronghold and Regional Therapeutic Area strategy, taking into account both weighted needs of the AP countries and feedback from the external scientific communities/thought leaders. You will drive the implementation of the AP Lung Cancer Medical Affairs Plan for assigned products across AP on time and within budget, support the Solid Tumor Therapeutic Area Lead as required in leading the AP Integrated Value Team (AP IVT) to develop and drive regional TA strategy, ensuring effective communications between the key regional and global groups and represent AP MAF for the assigned Global Medical Affairs Teams (GMAT, CDT ad hoc), on strategic and tactical matters, as delegated by the Solid Tumor TA Lead. You will also be required to act as the medical affairs expert and drive a unified Medical AP voice for a specific product or group of products (including pipeline in Lung Cancer and new indications of the products).**Core Activities**:
**AP Medical Affairs Franchise Leadership**
- Act as the AP MA expert especially for Lung Cancer
- In partnership with Solid Tumor Medical TA Lead, develop and drive the strategy for the TA
- Articulate the consolidated medical voice for AP for the TA
- Represent AP voice at regional and global teams for building the TA and brand strategy and provide input into the development plans of the products included in the TA
- Develop and maintain expertise in products, market trends, competitor activities etc.
- Build /maintain network with key external thought leaders to ensure clear understanding of external thinking and ensure the Company Medical strategy reflects the external environment
- Provide scientific leadership for AP cross functional and country MAF teams and ensure regular exchanges between regional and local MA teams
- Be accountable for the execution of the AP Medical Plan and budget for regional activities for TA and brands, as delegated by the Solid Tumor TA Lead
- Provide support to the AP Medical TA team to deliver AP MA Strategy and Plan: o Collaborate with internal stakeholders to gather input for the AP Medical Affairs Product Plan(s) for designated 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 insights to shape and direct implementation of product(s) strategies and plans
- Ensure effective and regular communications between Global, Regional and local MA 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 individual countries
- Provide Medical and Scientific training for internal and external stakeholders
- 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)- A member of the relevant Lung Cancer compound GMATs: o To represent the unified AP voice for the TA and input global Medical Affairs Strategy
- 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 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 the breakthrough research in line with the unmet medical/social needs in AP region**External Relationships**
- To build, maintain and leverage relationships with experts and other important stakeholders related to the activities in the Lung Cancer TA, new indications of the products and pipeline to gain input into the development of the product strategy, to specific protocols, and to services ensuring high-quality disease care.
**Product Safety and Regulatory Requirements**
- As per the J&J guidance and SOPs:
- Manage Product-related medical safety issues and provide input to the PV 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 as appropriate- Ensure adequate clinical input is provided to Core Compound Data Sheet or Patient Information by the MAF Director/ advisor update process and where appropriate ensure development and approval of clinical overview.
**Study Planning and Executio
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