Job Title Generic Careworkers & Health
Category Healthcare Support Workers, All Other
REGIONAL MEDICAL AFFAIRS DIRECTOR, SOLID TUMORS
Location: Any APAC location (no relocation provided)
The Regional Director, Medical Affairs will lead and be responsible for coordinating Medical Affairs (MAF) activities within Asia Pacific (AP) for the Therapeutic Area (TA) ensuring coordination and communication between Operating Companies, Asia Pacific and Global organizations in all medical matters for the Therapeutic Area.
As the regional lead of Solid Tumor, you will be reponsible for
1. Regional Therapeutic Area Medical Strategy
- 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.
- Validating AP TA strategy with key AP KOLs.
- Reviewing and approving the individual MAP Plans for the TA and managing the final sign off process.
- Ensuring alignment of local, regional and Global Medical Affairs strategy, plans and activities within the TA.
- Providing input to Global TA strategy to ensure AP requirements are represented.
- Ensuring cascade of relevant TA information (e.g. Global and AP plans and strategies) through AP Medical Affairs Directors.
- Developing and maintaining annual TA budget requests and ensuring that individual product budgets are being managed and tracked.
- Maintaining open communication and cooperation with AP Therapeutic Area Leaders within other TAs to ensure knowledge exchange and sharing of good practice.
- Collaborating 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
2. 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 Global Medical Affairs, Compound Development Teams, 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.
3. 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.
- 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
4. 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 organizations and meetings, symposia and medical education programs to maintain and improve knowledge and expertise.
5. 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).
6. Medical Education
- 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.
To be successful in this role you will have:
- Academic background with a Medical Degree and/or PhD essential and higher Medical Qualification desirable
- At least 5 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, academic or hospitals)
- Experienced in an area relevant to the TA, with ability to speak with authority in the TA
- Specialist in therapeutic field or equivalent experience
- 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
- Exceptional leadership, people management and development skills, motivated to develop, guide and reward high performance teams
- Highly customer and market place focused with an awareness of the importance of business results
- Awareness of and adherence to Johnson & Johnson Credo values
Asia Pacific-Philippines, Asia Pacific-Taiwan, Asia Pacific-South Korea, Asia Pacific-China, Asia Pacific-Malaysia, Asia Pacific-Japan, Asia Pacific-Thailand, Asia Pacific-Australia, Asia Pacific-Indonesia, Asia Pacific-India
Johnson & Johnson Pte. Ltd. (8435)