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Asia Pacific Medical Director

2 weeks ago

Singapore Johnson & Johnson Full time

In this role as the Asia Pacific (AP) Hematology Director, you will develop the AP Medical Strategy and AP Medical Affairs Product Plan for assigned Multiple Myeloma products in line with Global TA/Disease Area Stronghold and Regional Cross-Functional Therapeutic Area Team(s) (RCFT) strategies, 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 Multiple Myeloma Medical Affairs Plan for assigned products across AP on time and within budget and support the Hematology Therapautic 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. You will be required to represent AP MAF for the assigned Global Medical Affairs Teams (GMAT, CDT ad hoc), on strategic and tactical matters, as delegated by the Hematology TA Lead and act as the medical affairs expert and drive a unified Medical AP voice for a specific product or group of products.

Core Activities:

- AP Medical Affairs Franchise Leadership
- Act as the AP Medical Affairs expert especially for Multiple Myeloma
- In partnership with Hematology 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 communication 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 Hematology TA Lead
- Provide support to the AP Medical TA team to deliver AP MA Strategy and Plan:

- 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 Multiple Myeloma compound GMATs:

- 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 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

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 Execution
- Drive data gap analysis and data generation plan in support of the Hematology TA Lead
- Ensure that all AP MA protocols (Regional AP and single country) are in alignment with, and support, the medical strategy for the TA
- Act as Study Responsible Physician on regional AP studies and ensure all relevant SOPs are followed
- Provide scientific support for regional AP studies regarding clinical studies design, statistical plans, CSR, publ