Johnson & Johnson Careers

Regional TA Leader, Oncology Solid Tumor

Singapore, Singapore
Medical Affairs


Job Description

Requisition ID: 1905719912W

This role will report to Vice President Medical Affairs AP.

 

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.


OVERALL PURPOSE OF THE JOB:

  • To develop the AP Medical Strategy for the relevant Therapeutic Area 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 
  • To drive the implementation of the AP Medical Affairs Plan by the Medical Directors/Advisors, Medical Education Specialists and Coordinators, on time and within budget 
  • To co-lead the RCFT team to develop and drive regional TA strategy, ensuring effective communications between the key regional and global groups 
  • To represent AP MAF for the relevant TA at Global level (GMAT, CDT ad hoc), 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

  • Be the AP TA MAF expert
  • In partnership with co-lead of RCFT, 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 medical Directors/ Advisors, Medical Education Specialists and Coordinators and other AP functions in TA
  • Be accountable for the execution of the AP Medical Plan and budget for regional activities for TA and brands
  • Provide support to the AP Medical TA team to deliver AP MA Strategy and Plan:
    • Work with the Medical Directors/Advisors and Medical Education Specialists to gather input for the AP Medical Affairs Product Plan(s) for designated product(s)
    • Approve the  AP Medical Affairs Product Plan for allocated product(s) AP
    • 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 life cycle 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 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
  • 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 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
  • Accountable for line management of AP  Directors/Medical advisors, Medical Education Specialists and Coordinators
    • Allocation of responsibilities for product ownership and other activities
    • Objective setting
    • Performance management and performance evaluation
    • Coaching and feedback outside of the formal performance management processes
    • Development plans and training
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 disease 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 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 to VP MAF AP Region 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
  • Ensure that all AP MA 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 studies design, statistical plans, CSR, publications etc
  • Actively participate as core member of AP Protocol Review Committee
Publications and communications
  • Develop the AP MA publication and communication strategy and plans for the TA (as part of the MA 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 Annual plans for the products in the TA
  • Drive the medical education strategy and content to support the TA strategy
Other Activities as Required
  • Provide input to AP business development initiatives for allocated product(s) when requested
  • Partner with the late life cycle management group to provide proactive medical input for life cycle extension opportunities as appropriate


    Qualifications

    ESSENTIAL KNOWLEDGE & SKILLS

    • Excellent knowledge of the TA in general with a good knowledge of all products within TA.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 market place focused with an Big Picture orientation
    • Innovative with the ability to coordinate and drive a complex and changing environment
    • Ability to work effectively in a matrix environment
    • 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

    EXPERIENCE:

    • Medical degree and higher medical 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)
    • Management of people
    • Working in a  matrix system
    • Asia Pacific specificity awareness
    • 2 – 3 years 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. 

    1. Therapeutic Area Awareness 
    2. People management 
    3. Customer & Market Insight 
    4. Adaptability and flexibility
    5. Product Development Expertise 
    6. Organisation and Project Management 
    7. Publications and Scientific Presentations

    Primary Location
    Singapore-Singapore-Singapore-
    Organization
    Johnson & Johnson Pte. Ltd. (8435)
    Job Function
    Medical Affairs
    Requisition ID
    1905719912W