Medical Affairs Director, Colorectal and Head & Neck Cancer Closed

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Medical Affairs Group

Job Sub Function:

Medical Affairs

Job Category:

Scientific/Technology

All Job Posting Locations:

Singapore, Singapore

Job Description:

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 Colorectal & Head & Neck 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 Colorectal & Head & Neck 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 Colorectal & Head & Neck Cancer and new indications of the products).

 

This role requires strong Medical Affairs experience and a proven track record of strong strategic leadership, influence and execution. 

 

Core Activities:

AP Medical Affairs Franchise Leadership

• Act as the AP MAF expert for Colorectal & Head & Neck Cancer

• In partnership with Solid Tumor 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:

• • 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 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 markets

  • Provide Medical and Scientific training for internal and external stakeholders, especially for AP Medical Customer Excellence Team and market TA medical affairs to provide TA-specific MSL training

  • 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 Colorectal & Head & Neck Cancer compound GMATs:

• • To represent the unified AP voice for the DAS and input global Medical Affairs Strategy

  • To shape AP MAF Strategy for the DAS

  • 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

  • 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 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, J&J 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 J&J 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 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 or Study Responsible Scientist 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

• Participate as a member of AP Protocol Review Committee for assigned TA products

 

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 me