In this role as the Asia Pacific (AP) Medical Director Oncology, 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 (DAS) 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, represent AP Medical Affairs 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 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).
This role is open to an experienced Associate Medical Director who has strong strategic leadership and a proven track record in execution.
Core Activities:
AP Medical Affairs Franchise Leadership
• Act as the AP MAF expert for Lung Cancer
• In partnership with Solid Tumor Medical TA Lead, develop and drive the strategy for the DAS
• Articulate the consolidated medical voice for AP for the DAS
• Represent AP voice at regional and global teams for building the DAS 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 strong collaborations between regional and local MAF teams
• Be accountable for the execution of the AP Medical Plan and budget for regional activities for DAS 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)
o 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
o Leverage product(s) expertise, medical and market insights to shape and direct implementation of product(s) strategies and plans
o 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 coordination between AP Medical Affairs, CDT, Strategic Marketing, Health Economics and individual countries
o Provide Medical and Scientific training for internal and external stakeholders, especially to work with AP Medical Customer Excellence Team and countries TA to provide MSLS trainings
o 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 DAS and input global Medical Affairs Strategy
o To shape AP MAF Strategy for the DAS
o 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 DAS, new Assets in the DAS and new indications
o To ensure input into the Global Clinical Program with the aim to have representation from appropriate AP countries
o 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 DAS, 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:
o Manage Product-related medical safety issues and provide input to the PV AP Pharmacovigilance & Medical Compliance, J&J AP Medical Affairs and Global Safety Management Teams (SMTs).
o Work with Regulatory Affairs & Product Issue Management Team to coordinate and manage product-related Issues and support major quality incidents / recalls throughout J&J AP
o 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 Solid Tumor TA Lead
• Coordinate and execute AP regional data generation activities within budget and timelines
• Ensure that all AP MAF protocols (Regional AP and single country) are in alignment with, and support, the medical strategy for the DAS and new indications of the asset
• 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, publications as appropriate etc.
• Review and approve single country concepts (intervention, Real World Evidence, Investigator Initiated Studies etc.) in ReCAP
• Participate as a member of AP Protocol Review Committee for assigned TA products
Publications and communications
• Develop the AP MAF publication and communication strategy and plans for assigned DAS (as part of the MAF Strategy and Plan for allocated product(s), in alignment with the regional and Global publication strategy).
Medical Education
• Develop the Regional AP Medical Education activities for assigned DAS as part of the MAF Annual plans for the products
• Manage and execute the regional Medical Education strategy and events, including company standalone program, scientific symposia, publications, speaking engagements, webinars, advisory boards and steering committees etc.
Other Activities as Required
• Provide input to AP business development initiatives for allocated product(s) when requested
• Medical review and approval of market research materials
QUALIFICATIONS
• PhD or Medical degree qualification essential
• 10+ years industry (8+ years for an Associate Medical Director) / business experience with a minimum of 3 years experience in a relevant area for this function (e.g. Medical Affairs or Clinical R&D)
• 5+ years experience in clinical medicine in an area relevant to the DAS is a plus
• Working in a matrix system
• Asia Pacific specificity awareness
• Excellent knowledge of solid tumor (especially Lung Cancer) with a good knowledge of all products within the DAS
• In-depth knowledge and hands-on experience of clinical trial design and study data analysis (e.g. statistical analysis)
• Good knowledge of Drug development process, MAF specific activities and GCP requirements
• Awareness of AP Regulatory and reimbursement environment
• Good knowledge of study execution, pharmacovigilance
• Sound knowledge of study publication processes and publications
• Highly customer and marketplace focused with a Big Picture orientation
• Innovative with the ability to coordinate and drive a complex and changing environment
• Ability to work effectively in a matrix environment and cross-functionally
• Strong leadership skills, capable of driving a multi-cultural, virtual team
• Very strong and demonstrable communication and influencing skills that can impact at a Regional and Global level
• Awareness of and adherence to Johnson & Johnson Credo values
The role is AP based and is likely to involve extensive AP and International travel. The role holder will be expected to be based in Singapore or his/her current country of residence in AP Region as long as easy access to travel/transportation and local hosting is available at a J&J office.
