PART 1: ROLE DESCRIPTION
Asia Pacific Regional Franchise Associate Medical director
Medical Affairs Director, J-C AP (solid)
DIRECT REPORTS YES/NO:
Asia Pacific SKILL TRACK AND SPECIALTY:
Therapeutic Area Medical Affairs
OVERALL PURPOSE OF JOB:
To lead and be responsible for coordinating Medical Affairs (MA) activities within AP for the Therapeutic Area (TA) ensuring coordination and communication between Operating Companies, AP and Global organisations in all medical matters for the TA.
To develop the AP medical strategy and oversee the development and implementation, by the country medical directors, of individual Medical Affairs Product Plans for a given TA, ensuring close co-operation with Marketing and alignment with Global strategy.
To drive the development and presentation of a unified Medical AP voice on the Compound Development Team (CDT) and within other AP functions (e.g. Commercial, Regulatory Affairs (RA), Health Economics etc.)
To act as the AP Medical Affairs expert for the TA
Therapeutic Area Medical Strategy
Responsible for coordinating input from the country MAF plans to develop and champion the AP medical strategy and vision for a given TA including full lifecycle management, and encompassing pre-marketing activities
Responsible for validating AP TA strategy with key AP Key Opinion Leaders (KOLs)
Responsible for reviewing and approving the individual MAP Plans for the TA and managing the final sign off process
Responsible for ensuring alignment of local, regional and Global Medical Affairs strategy, plans and activities within the TA
Responsible for providing input to Global TA strategy to ensure AP requirements are represented
Responsible for ensuring cascade of relevant TA information (e.g. Global and AP plans and strategies) through AP Medical Affairs Directors
Accountable for developing and maintaining annual TA budget requests and ensuring that individual product budgets are being managed and tracked
Responsible for maintaining open communication and cooperation with AP Therapeutic Area Leaders within other TAs to ensure knowledge exchange and sharing of good practice
Close collaboration with AP commercial lead and active participation in AP commercial team meetings to ensure alignment and drive future regional development plans.
Medical affairs leadership in Regional Therapeutic Area Teams (RTATs)
Regional medical affairs leadership role in planning and implementation of patient access programs.
MAF Team Leadership
Responsible for coaching and supporting the Country medical affairs teams in developing and executing their MAP Plans
Responsible for identifying and managing the integration points across the MAF Teams and with other functions and geographies to ensure alignment, minimise risk and eliminate duplication (e.g. coordination of AP studies, interactions with external customers and stakeholders)
Coordinate input from the MAF teams to other AP functions such as Regulatory Affairs (RA), Pharmacovigilance / Benefit Risk Management (PV/BRM) etc.
Act as a role model with respect to adherence to, and tracking compliance with, relevant Standard Operating Procedures (SOPs), and ensure similar adherence among direct reports
Accountable for communicating relevant decisions from the GMAB, CDT etc. to appropriate MAF staff
Accountable for effective budget and resource management (headcount, travel, TA activities, etc.) within the TA setting and managing priorities as appropriate
AP Medical Affairs Leadership Team Membership
Member of the AP Medical Affairs Leadership Team led by the Medical Directors, J-C AP
Therapeutic Area Representation
Build internal / external reputation as a credible MA expert and advocate for the TA. Act as an AP TA point of contact (e.g. for coordination of relationships with external alliances/ licensing business partners, and for facilitating interactions with interfacing functions)
Provide medical insight and support to AP business development initiatives as appropriate
Provide AP medical expertise and input into Global MAF plan and ensure appropriate input into CDTs via Project MARDI
Provide medical input into relevant clinical components of AP regulatory submissions as necessary, and support AP Commercial and New Product Teams where appropriate
Responsible for overseeing major medical safety and product issues, collaborating with countries to provide appropriate input to BRM
Internal & External Network/ KOL Management
Develop TA KOL management strategy and plan in collaboration with LOCs, facilitating the allocation of responsibility for managing specific KOL relationships along clearly defined lines
Provide MA oversight and support for market development activities (e.g. Global and AP KOL development strategies, communications plans)
Liaise with PRD TA, CDT, GCO and LOCs where appropriate to establish and manage an external network of agencies, investigators, KOLs, and patient groups in order to further the TA strategy
Responsible for engaging and influencing top tier KOLs within AP
Develop a pan-AP and Global network across Medical Affairs, Regulatory, BRM and Marketing functions to ensure unified AP voice
Build an internal and external reputation as TA expert participating in appropriate professional organisations and meetings, symposia and medical education programmes to maintain and improve knowledge and expertise
Product Safety and Regulatory Requirements
Work with the local countries MAF to manage Product-related medical safety issues and provide input to the regional compliance person
Support the countries and work with Regulatory Affairs to coordinate and manage Product-related Issues and support major quality incidents / recalls throughout AP
Respond to issues and enquiries escalated by the EMADs as appropriate
Provide, where designated as the Study Responsible Physician, requested information as specified in the Call For Information (CFI) distributed by BRM, during the initiation of Periodic Safety Update Reports (PSUR)
Responsible, where designated as the Study Responsible Physician, for the writing and the quality of the Study Specific Safety Summary for pan-AP studies, per ASR guidance and the J&J template. Also responsible for ensuring that ASR reporting to the Competent Authorities and IECs for IMPs with existing ASR schedules is compliant with the procedures described in BRM SOPs
Provide clinical input to CCDS or sMPC update process and where appropriate ensure development and approval of clinical overviews
Study Planning and Execution
Work with the country MAF teams to ensure that all protocols are in alignment with, and support, the medical strategy:
Give guidance on the development of study concepts and scientific content for protocols
Accountable for approving study concepts according to defined timelines
Accountable for the final approval of study protocols, ensuring that all comments have been incorporated
Be responsible for putting together the One Package Plan for the TA and manage the plan with the help of the Project Manager
Accountable for the internal approval of the Final Study Report for all studies in the TA
Work with the country MAF teams to ensure that Clinical Studies are published and in accordance with the regional and global publication strategy
Responsible for ensuring that Project Managers are accountable for appropriate tracking and reporting of data (e.g. entering accurate study information and data into Clinical Trial Management System)
Develop and conduct lectures/educational sessions for appropriate healthcare audiences.
Conduct training for internal audiences.
Review and approve educational and sales materials for medical and scientific accuracy.
Consult in the selection and development of expert speakers.
Fluency in English language required
Sign off on Regional Medical Affairs Strategy and individual Country MAF Plans for the TA
Resource management within the TA
Communication of relevant decisions from global and regional levels
Approval of TA study concepts
Final approval of study protocols
Approval of Final Study Report for all Studies within the TA
Approval of TA Medical Education plans
1.4 JOB LOCATION:
The role is regional and is likely to involve regional and International travel.
The role holder will be expected to be based in their current country of residence.
PART 2: ROLE REQUIREMENTS
2.1 ESSENTIAL KNOWLEDGE & SKILLS:
Exceptional leadership, people management and development skills, motivated to develop, guide and reward high performance teams
Excellent knowledge of the TA in general including main competitors
Good knowledge of all compounds in TA with in depth knowledge of at least one compound
In-depth knowledge of study methodology, study data review and analysis
Excellent knowledge of study publication processes and publications within the relevant TA
Good knowledge of study execution, benefit risk management and regulatory affairs
Very strong and demonstrable communication and influencing skills that can impact at a Global and regional level
Highly innovative with the ability to drive a complex and changing environment and effectively manage and resolve issues within the TA
Highly customer and market place focused with an awareness of the importance of business results
Awareness of and adherence to Johnson & Johnson Credo values
Board-certified specialist in therapeutic field or equivalent experience
Academic background with a medical degree and higher medical qualification essential
Experienced in clinical medicine in an area relevant to the TA
At least 3 years industry/business experience with a minimum of 4 years experience in a relevant area for this function (e.g. Medical Affairs or Clinical R&D, academic or hospitals)
2.3 CORE COMPETENCIES REQUIRED FOR THIS ROLE:
Change Management and Innovation
Promotes Innovation and Continuous Learning, Implements Positive Change Adjusts priorities and demonstrates adaptability, identifies and implements new or different ways to achieve goals.
Clinical Business Knowledge
Executes Against the Plan Uses knowledge of the drug development process in the planning and management of clinical studies. Develops forecasts for study budgets.
Clinical Resource Studies
Cultivates a Results-Driven Environment, Forges a Vision of the Future Ensures appropriate supervision of medical safety for study subjects. Influences the development of clinical strategy and directs the execution of clinical strategies and programs. Provides clinical and scientific input and key design elements in the development of protocols.
Builds Interdependent partnerships. Develops and delivers information in a clear and concise manner. Listens actively and shares relevant information with others.
Develops and Coaches Others
Develops People for Optimal Performance, Creates an Achievement Environment Provides consistent and timely feedback and coaching to team and facilitates this process. Proactively evaluates and develops individuals; business partners with team to facilitate the development planning process.
Partnership and Collaboration
Builds Interdependent Partnerships Develops effective working relationships with business partners.
Problem Solving and Decision Making
Manages Complexity Identifies and analyzes complex problems. Develops and implements effective solutions to complex multi-faceted problems and issues.
Focuses Externally Demonstrates an in-depth understanding of the relevant drugs products and the disease states. Remains current with market knowledge and trends.
Project and Resource Management
Manages Complexity Develops project plans and manages multiple projects to achieve goals established within established metrics and timelines. Evaluates and manages time and resources.
Self-Development and Continuous Learning
Personal Accountability Collaborates to identify strengths and developmental areas; creates, owns, and implements professional development plan.