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:
Multi-Family Medical Affairs
Job Category:
People Leader
All Job Posting Locations:
Singapore, Singapore
Job Description:
ABOUT INNOVATIVE MEDICINE
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
OVERALL PURPOSE OF THE JOB:
- To develop an Asia Pacific (AP) Medical Affairs Strategic Plan for the Solid Tumours Therapeutic Area (TA) in line with Global TA and Disease Area Strongholds and the Regional Integrated Value Team (IVT) strategies, to include the needs of AP markets with input from key APAC thought leaders and the APAC external scientific community
- To drive implementation of the AP Medical Affairs Strategic Plan through Medical Directors and Advisors, Medical Education Specialists and Coordinators, on time and within budget
- To co-lead the IVT to drive effective representation, communication and support for the AP Medical Affairs Strategic Plan between key regional and global teams
- To represent AP MAF for the relevant TA at the Global level (GMAT, CDT, IEGP/EG, 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, drive and advocate for the APAC 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 TA medical Affairs Strategy reflects the external environment and HCP and patient needs
- 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 Affairs Strategic 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 Strategic 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, education 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:
- Represent the unified AP voice for the TA
- Shape AP MAF Strategy for the TA
- Ensure timely and reliable input from AP into the Compound Development Team (CDT), including input into phase II/III study designs, and advocate for APAC country and site selection for the respective TA
- Ensure input into the Global Clinical Program with the aim to have representation from appropriate AP countries
- 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
- Maintain and leverage relationships with experts and other important stakeholders across APAC related to the activities in the TA to gain input into the development of the product strategy, specific protocols, and services that ensure 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 such as RMP, ARMA and CARMA requirements and provide input to AP Pharmacovigilance, , and Global Safety Management Teams (SMTs)
- Work with Regulatory Affairs, Commercial Quality and Product Issue Management Teams to coordinate and manage product-related issues and support major quality incidents / recalls throughout Janssen AP
- Work with AP compliance functions, such as HCC, to ensure all activities are fully compliant with J&J HCBI guidelines
- 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 and where appropriate ensure development and approval of clinical overviews
Study Planning and Execution
- Drive data gap analysis, data generation and data dissemination plans in line with the Medical Strategic Plan for assigned products
- Ensure that all AP MAF protocols (Regional AP and individual market) are in alignment with, and support, the AP Medical Affairs Strategy for the TA and product
- For AP regional studies, ensure there is an assigned Study Responsible Physician (SRP) / Study Responsible Scientist (SRS), and ensure they follow AP Medical Affairs Study Planning and Execution SOPs
- Provide Medical Directors/Advisors and local TA teams with scientific support regarding clinical study design, statistical analysis plans, CSRs, publications, etc.
- Actively participate as a core member of the AP Protocol Review Committee
Publications and communications
- Develop the AP MAF publication and communication strategy and plans in line with the AP Medical Affairs TA and product Strategy for allocated product(s), and in alignment with the Global publication strategy
Medical Education
- Review and approve Regional AP Medical Education activities as part of the MAF plans for the products in the TA
- Drive the medical education strategy and content in support of the TA
Other Activities as Required
- Provide input to AP business development initiatives for allocated product(s) when requested
- Partner with the late lifecycle management group to provide proactive medical input for lifecycle extension opportunities as appropriate
ACCOUNTABILITIES:
- Development of AP Medical Affairs TA Strategy
- Development of the MAF Annual Business Plan for the TA including data generation projects (clinical studies, registries, etc.) and data dissemination projects (Medical education, publications, etc.)
- Development and management of product and T&E budget for Regional MAF activities
- Line Management of Medical Directors and Advisors; oversight of contractors and consultants as required according to the needs of the business
ESSENTIAL KNOWLEDGE & SKILLS:
- Excellent knowledge of the TA in general and a working knowledge of products in the TA
- In-depth knowledge of and hands-on experience with clinical trial design and execution, data analytics (e.g. statistical techniques) and communication of results
- Good knowledge of the drug development process, MAF specific activities and GCP requirements including pharmacovigilance
- Awareness of AP Regulatory and reimbursement environment
- Skilled presenter of study results with medical writing experience and awareness of good publication practices
- Customer and market place focused with a patient centric and Big Picture orientation
- Innovative and highly collaborative with the ability to coordinate and drive change in a complex matrix environment
- Strong leadership skills, capable of driving a diverse, multi-cultural, virtual team
- Very strong and demonstrable communication and influencing skills that can deliver at cross-functional, Regional and Global levels
- Awareness of and adherence to Johnson & Johnson Credo values
EXPERIENCE:
- Medical Degree or equivalent (e.g. Ph.D., Pharm.D.) qualification essential
- 5+ years experience in clinical medicine in an area relevant to the TA
- 8+ years industry / business experience with a minimum of 3 years experience in a relevant area for this function (e.g. Medical Affairs or Clinical R&D)
- Experience managing a team of high performing professionals
- Previous work in a matrixed environment and experience in the AP region
- Project management, team leader or functional line management experience
