EMEA Therapeutic Area Leader, Haematology/Oncology Job

Job description

EMEA Therapeutic Area Leader, Haematology/Oncology-00000UYBDescriptionTo develop the EMEA medical strategy for the Haematology / Oncology Therapeutic Area and oversee the development and implementation, by the designated EMADs, of individual EMEA Medical Affairs Product Strategies and Plans (MAP Plan), ensuring close co-operation with other EMEA functions (Strategic Marketing, Health Economics, Regulatory) and alignment with the Global TA strategy.
To lead the Haematology / Oncology EMEA Therapeutic Area team (ETAT) of EMEA Medical Affairs Directors (EMADs) and Medical Advisors and be responsible for coordinating Medical Affairs (MA) activities within EMEA for the Therapeutic Area (TA) ensuring coordination and communication between Operating Companies, EMEA and Global organisations in all medical matters for the TA.To present a unified Medical EMEA voice and provide input into the Global TA strategy towards the VP Global Medical Affairs and R&D senior leadership for a given TA.To represent the TA medical voice at the Therapy Area Strategy Team (TAST) and to input into the portfolio optimisation and prioritisation recommendation for the Market Access Leadership Team (MALT) and EMEA Leadership Team (ELT).To represent the TA within the EMEA Medical Affairs Leadership Team (EMALT).To act as the EMEA Medical Affairs expert for the TA, including support for other EMEA functions (e.g. Strategic Marketing, Regulatory Affairs (RA), Health Economics etc.)MAIN ACTIVITIES/TASKS:Therapeutic Area EMEA Medical Strategy
- responsible for the Haematology / Oncology TA
- Responsible for developing the EMEA Medical Strategy for the TA in alignment with the Global TA strategy and based on feedback from operating companies
- Responsible for coordinating input from the ETAT (based on individual MAP Plans) to develop and champion the EMEA medical strategy and vision for a given TA including full lifecycle management, and encompassing pre-marketing activities
- Responsible for validating EMEA TA strategy with key EMEA thought leaders
- Responsible for reviewing and approving the individual MAP Plans for the TA
- 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 EMEA requirements are represented
- Responsible for ensuring cascade of relevant TA information (e.g. Global and EMEA plans and strategies) through EMEA Medical Affairs Directors (EMADs), EMEA Medical Advisors, Medical Affairs Product Teams and Country Medical Directors
- Accountable for developing and maintaining annual TA budget requests and overseeing the TA budget
- Responsible for maintaining open communication and cooperation with EMEA Therapeutic Area Leaders (ETALs) within other TAs to ensure knowledge exchange and sharing of good practice
- Develop and maintain detailed knowledge in product portfolio, market trends, competitor activities etc.
- Build up/maintain network with external thought leadersETAT Team Leadership
- Accountable for line managing the EMADs:
- Allocation of responsibilities for product ownership and other activities, such as diligence of licensed and acquired products, within the ETAT
- Goals and Objective setting
- Performance management and performance evaluation
- Coaching and feedback outside of the formal performance management processes
- Career development
- Ensuring that appropriate training (e.g. internal TA seminars) in TA, Medical Affairs, functional skills, Good Clinical Practice (GCP) and required SOPs is undertaken
- Responsible for coaching and supporting the TA EMADs in their role in the Integrated Brand Value Teams (IBVTs), the Medical Affairs Product Teams (EMAPTs) and the Medical Affairs Functional Network.
- Responsible for identifying and managing the integration points across the EMAP Teams within the TA and with other functions and geographies to ensure alignment, minimise risk and eliminate duplication (e.g. coordination of EMEA studies, interactions with external customers and stakeholders)
- Coordinate input from the ETAT to other EMEA functions such as Regulatory Affairs (RA), Health Economics, Strategic Marketing, Pharmacovigilance 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 EMALT, Global Medical Affairs, R&D etc. to EMADs
- Accountable for effective budget and resource management (headcount, travel, TA activities, etc.) within the TA setting and managing priorities as appropriateEMEA Medical Affairs Leadership Team Membership
- Member of the EMEA Medical Affairs Leadership Team led by the VP Medical Affairs Janssen EMEA
- Responsible for representing the TA at the EMALT and communicating relevant decisions and discussions back to the EMADsEMEA Haematology / Oncology Therapy Area Strategy Team (TAST)
- Member of the EMEA TAST
- Responsible for representing the TA medical voice on the TAST, and working closely with other TAST members (including Regional Commercial Strategy Leader (RCSL), Health Economics Market Access and Reimbursement TA Lead and Regulatory TA lead) shaping the portfolio strategy and delivering portfolio optimisation and prioritisation recommendations to the MALT and ELT.Therapeutic Area Representation
- Build internal / external reputation as a credible MA expert and advocate for the TA. Act as an EMEA 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 EMEA business development initiatives as appropriate
- Provide EMEA medical expertise and input into Global Medical Affairs and R&D and ensure EMADs deliver appropriate input into the IBVTs and Global Medical Affairs and R&D
- Provide medical input into relevant clinical components of EMEA regulatory submissions as necessary, and support IBVTs in collaboration with EMADs where appropriate
- Responsible for overseeing major medical safety and product issues, collaborating with EMAD to provide appropriate input to Global Medical Safety (GMS).
- Work with the EMALT, EMADS and Country MDs to identify TA skills / resource gaps on an EMEA and Country level and develop EMEA succession plans for key TA staff. Where TA skills / resource gaps are identified at a Local level, ensure this is communicated effectively, and handed over to Country MDs for review/ actionInternal & External Network/ KOL Management
- Develop TA KOL management strategy in collaboration with OpCos, 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 EMEA KOL development strategies, communications plans)
- Liaise with R&D TA, CDTs, EMADs and OpCos where appropriate to establish and manage an external network of agencies, investigators, thought leaders, and patient groups in order to further the TA strategy
- Responsible for engaging top tier thought leaders
- Develop a pan-European and Global network across Medical Affairs, Regulatory, GMS and Marketing functions to ensure unified EMEA 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 expertiseProduct Safety and Regulatory Requirements
- As per the J&J guidance and SOPs:
- Work with the designated EMAD to manage Product-related medical safety issues and provide input to the EMEA Head Pharmacovigilance & Medical Compliance.
- Support the designated EMAD to work with Regulatory Affairs to coordinate and manage Product-related Issues and support major quality incidents / recalls throughout Janssen EMEA
- Respond to issues and enquiries escalated by the EMADs as appropriateStudy Planning and Execution
- Work with the EMADs to ensure that all EMEA MA protocols (pan EMEA and single country) are in alignment with, and support, the medical strategy:
- Give guidance on the development of pan-EMEA study concepts and scientific content for pan-EMEA protocols
- Accountable for approving TA pan-EMEA study concepts according to defined timeline
- Accountable for the final approval of pan EMEA study protocols, ensuring that all comments have been incorporated after review by the appropriate Protocol Review Committee (PRC)
- Review and approve single country interventional protocols
- Provide oversight to the EMADs to support them in the timely study concept and protocol development of pan
- EMEA studies in accordance with current SOPs
- Accountable for the internal approval of the Final Study Report for pan-EMEA studies
- Work with the EMADs to ensure that Clinical Studies are published and in accordance with the Global Publication SOP
- Ensure that the EMADs work closely with Global Clinical Operations (GCO) and the Regional Therapeutic Area Expert (RTAE) to deliver on medical affairs study timelines and support R&D studies via engagement of the medical affairs functional network.#JNJPhysiciansQualificationsESSENTIAL 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 valuesEXPERIENCE:
- Board-certified specialist in therapeutic field or equivalent experience in TA highly desirable
- Academic background and higher medical/scientific qualifications essential
- Preference for a medical degree
- 8 + 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)
- 3 – 5 years team leadership or functional line management experience essential with project management experience desirableCORE COMPETENCIES REQUIRED FOR THIS ROLE:
- Leadership
- Adaptability and Flexibility
- Managing Internal and External Relationships
- Product Development Expertise
- Product/Brand Awareness
- Organisation & Project Management
- Customer & Market InsightSPECIAL REQUIREMENTS:
- Fluency in English language requiredFluency in additional EMEA languages an advantage
- Able to accommodate substantial travelJOB LOCATION:The role is EMEA based and is likely to involve extensive EMEA and International travel. The role holder will be expected to be based in their current country of residence as long as easy access to travel/ transportation and local hosting is available in a Janssen office.
Primary Location:Europe/Middle East/AfricaOrganization: Janssen Pharmaceutica N.V. (7555)Travel:Yes, 50 % of the TimeJob Function: Medical Affairs