Job Description - Medical Affairs Therapeutic Area Leader (M/F) - Oncology (2506234981W)
Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
For our pharmaceutical sector, we are currently looking for a Therapeutic Area Leader – Oncology to be based in our Madrid office on a permanent contract.
OVERALL PURPOSE OF JOB
Responsible for Medical Affairs strategy and plan, including evidence generation activities, Medical Education and MSL plan in the assigned therapeutic area/product(s) at national level.
Directs the operational function in Medical Affairs to achieve organizational objectives taking key decisions during the conduct.
1. Responsible for the design, approval and oversight of development and implementation of evidence generation activities, including Phase IIIb, Phase IV trials, non-interventional studies, registries, other RWE projects, etcetera at local and regional (EMEA) level. Responsible for the collaboration with Global Clinical Operations in the clinical development plan and site selection.
2. Ensures the adequate management of Investigator Initiated Studies (IIS) in the designed area.
3. Ensures the development and implementation of a publication plan.
4. Ensures the implementation of the Medical Educational program, in collaboration with the external Therapeutic Area Steering Committee (TASC).
Establish and reinforce solid professional relationships with national and international leading specialists.
To coordinate with the MSL manager, the successful development and implementation of the MSL plan at national and regional level.
Responsible for co-leading the strategy and providing scientific guidance in the Therapeutic Area/product with the Business Unit Manager and participating as a member of CVT for the decisions to be taken in the therapeutic area.
Responsible for the assigned personnel within Therapeutic Area, including recruitment, collaboration, development, retention and management of low performance and all people management related responsibilities.
Responsible for design and implementation of internal training plan.
Active participation in the co-create structure in each TA at EMEA level and member of Medical Affairs Steering Committee (MASC) at local level.
MAIN ACTIVITIES/TASKS
1. Responsible for the design, approval and oversight of development and implementation of the Medical Affairs strategy and plan in the assigned area/product(s), including evidence generation, Medical Education and MSL plan.
2. Responsible for hiring, training, development, management and performance evaluation of direct reports.
3. Maintains collaborative working relationship between medical affairs and internal stakeholders to deliver timely and expert support to product development.
4. Manages and delegates work of direct reports and establishes accountability for assignments.
5. Manages budget, contract negotiation and oversight of vendor activities.
6. Manages the design and implementation plan of Medical Affairs program, including identification of critical paths, budget management and control and tracking of all projects.
7. Development and maintenance of a contact network with national and international thought leaders.
8. Manages creation of educational, promotional and reporting materials for use by internal stakeholders.
9. Ensures review of promotional material.
10. Ensures collaboration with external companies in co-promoting our products.
11. Implements plans for clinical studies, including staffing and budgeting according to the EMEA and national strategy in coordination with Clinical Operations (GCO-MAO) and Project Management.
12. Ensures that every evidence generation activity is conducted according to all applicable guidelines, regulations, company procedures and high ethical/quality standards.
13. Ensures design and implementation of a publication plan, including preparation and review.
14. Implements policies and procedures for development and provision of medical information pertaining to the company's products for internal use by customer and by government.
15. Represents the local strategy and participates or ensures participation as a member of the EMEA Medical Affairs Product Team (EMAPT) and co-create team.
16. Observes and promotes all regulatory requirements as defined per applicable regulations, rules and procedures established by the Company, and notifies any violation or deviation to the immediate supervisor or appropriate authority.
17. Complies with own training requirements to perform duties of own job. Assures that all assigned personnel have the appropriate training and qualifications to perform all duties and responsibilities and ensures inspection readiness with respect to personal training compliance, and availability of recent CV and individualized job description.
18. Participates in the company's drug surveillance/product safety programs which includes following up on adverse reaction reports and Risk Management Plans.
19. Reports all suspected adverse reactions, serious or non-serious, I may be aware of within a maximum of 24 hours after being aware of it and communicates it to the Pharmacovigilance Department.
People Management
1. Conduct regular informal Career Conversations with all direct reports to ascertain their career and development aspirations in line with Janssen Talent approach at a frequency agreed between manager and line report/s.
2. Set clear performance standards, provide feedback and coaching, and hold direct reports accountable for key deliverables.
3. Conduct annual performance reviews with direct reports to help support the creation of a diverse, high performing team.
4. Seek input on performance of direct reports in activities on other teams and committees, and measure and reward staff based on contribution to Global, EMEA and Country functional activities.
5. Be accountable for the development of succession plans for their Area.
Additionally, for all employees involved in Research Related Activities (RRA):
1. Ensure safety reporting requirements (timely AE/PQC reporting) as set out in company policies and SOPs (Standard Operating Procedures) are met and appropriately managed when planning projects, developing materials, executing projects and contracting vendors.
2. Ensure HCC and legal requirements (Fair Market Value, Transfer of Value rules, Promotional Materials rules) are fully understood, appropriately managed and complied with when planning projects, developing materials, executing projects and contracting vendors.
3. Ensure inspection readiness with respect to personal training compliance, and availability of recent CV and individualized Job Description.
Qualifications
* Successful professional background of minimum 5 years in medical affairs or correlated functions.
* Successful experience in managing and developing teams while driving performance.
* University degree in medicine, science or related areas.
* Fluent in English and Spanish.
* Deep knowledge of the therapeutic area, scientific acumen and communication skills.
* Strategic business vision.
* Solid business acumen and pharmaceutical market experience.
* Leadership and management skills.
Primary Location
Europe/Middle East/Africa-Spain-Community of Madrid-Madrid
Organization
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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