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The AP Associate Medical Director Neuroscience and Cardiopulmonary medicine 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 (OpCo), AP and Global organizations in all medical matters for the Therapeutic Area.
Therapeutic Area Medical Strategy
- Coordinate 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 pre-marketing activities.
- Review and approve the individual MAP Plans for the TA and managing the final sign off process.
- Ensure alignment of local, regional and Global Medical Affairs strategy, plans and activities within the TA.
- Provide input to Global TA strategy based on AP unmet needs and external stakeholders Insights to ensure AP requirements are represented.
- Ensure cascade of relevant TA information (e.g. Global and AP plans and strategies) through OpCo Medical Affairs counterparts.
- Develop and maintain annual TA budget requests and ensuring that individual product budgets are being managed and tracked.
- Maintain open communication and cooperation with AP TA Leaders within other TAs to ensure knowledge exchange and sharing of good practice.
- Collaborate with AP commercial lead and participate 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
- Coach and support the Country medical affairs teams in developing and executing their MAP Plans.
- Identify and manage the integration points across the MAF Teams and with other functions and geographies to ensure alignment, minimize 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.
- Communicate relevant decisions from Global Medical Affairs, Compound Development Teams, etc. to appropriate MAF staff.
- Effective budget and resource management (travel, TA activities, etc.) within the TA setting and managing priorities as appropriate.
Therapeutic Area Representation
- Build internal / external reputation as a credible scientific 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.
- Oversee 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 to further the TA strategy.
- Engage and influence 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.
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 Scientist, requested information as specified in the Call For Information (CFI) distributed by BRM, during the initiation of Periodic Safety Update Reports (PSUR).
- Provide clinical input to CCDS or sMPC update process and where appropriate ensure development and approval of clinical overviews.
Study Planning and Execution
- Lead the development of regional IEGP evidence generation plans and activities to address data gaps to achieve better patient outcomes & aligned overall brand strategy. Coordinate AP and country IEGP proposals and plans with global IEGP process so AP views are represented,
- 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
- 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.
- Ensure 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).
Medical Education
- Develop and conduct lectures/educational sessions for appropriate healthcare audiences and measure the impact.
- 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.
RELATED EXPERIENCE:
- Academic background with a Medical Degree and/or PhD or 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
- Fluency in English language required
- Awareness of and adherence to Johnson & Johnson Credo values
