Job Description

OVERALL PURPOSE OF THE JOB:

• To develop an Asia Pacific (AP) Medical Strategy for the Solid Tumour Therapeutic Area (TA) in line with Global TA and Disease Area Strongholds and Regional Integrated Value Team (IVT) strategies, including the needs of AP markets and input from local thought leaders and the external scientific community
• To drive implementation of the AP Medical Affairs Plan by Medical Directors and Advisors, Medical Education Specialists and Coordinators, on time and within budget
• To co-lead the IVT to develop and drive a regional TA strategy, ensuring effective communications between key regional and global teams
• To represent AP MAF for the relevant TA at the Global level (GMAT, CDT, 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 and drive the 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 medical strategy reflects the external environment
• 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 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 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 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:
  • 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 study 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 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

• To maintain and leverage relationships with experts and other important stakeholders related to the activities in the TA to gain input into the development of the product strategy, to specific protocols, and to services ensuring 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 and provide input to 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 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 update process and where appropriate ensure development and approval of clinical overviews

Study Planning and Execution

• Drive data gap analysis, data generation and data dissemination plans
• Ensure that all AP MAF protocols (Regional AP and single country) are in alignment with, and support, the medical strategy for the TA
• For regional studies, ensure there is a Study Responsible Physician (SRP), and oversee the SRP 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 for the TA (as part of the MAF Strategy and Plan for allocated product(s), in alignment with the Global publication strategy)

Medical Education

• 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

JOB LOCATION: 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 the AP Region as long as easy access to travel/transportation and local hosting is available at a J&J office.

Qualifications
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

CORE COMPETENCIES REQUIRED FOR THIS ROLE: Candidates must demonstrate a high level of expertise in each of the following core competencies - the competencies are ranked in order of importance for this role.

• Therapeutic Area Knowledge

• People Management Experience

• Customer & Market Insight

• Adaptability and Flexibility

• Product Development Expertise

• Organisation and Project Management

• Publications and Scientific Presentations

SPECIAL REQUIREMENTS:

• Fluency in English language required
• Fluency in additional AP languages an advantage
• Able to accommodate substantial travel

Primary Location
Singapore-Singapore-Singapore-
Organization
Johnson & Johnson Pte. Ltd. (8435)
Job Function
R&D
Requisition ID
2206009576W