Medical Affairs Therapeutic Area Leader (H/F) - Oncology

Johnson & Johnson

1mo ago

Job
Full-time
Senior Level
Research & Development
Healthcare
Madrid

AI generated summary

You need 5+ years in medical affairs, team management experience, a relevant degree, fluency in English and Spanish, deep therapeutic knowledge, strategic vision, and strong leadership skills.
You will lead Medical Affairs strategy, oversee evidence generation and educational programs, manage budgets, ensure compliance, and cultivate relationships with key specialists in oncology.

Requirements

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

Responsibilities

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.
Responsible for the design, approve 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.
Ensures the adequate management of Investigator Initiated Studies (IIS) in the designed area.
Ensures the development and implementation of a publication plan.
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 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.
Responsible for the design, approve 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.
Responsible for hiring, training, development, management and performance evaluation of direct reports.
Maintains collaborative working relationship between medical affairs and internal stakeholders to deliver timely and expert support to product development.
Manages and delegates work of direct reports and establishes accountability for assignments.
Manages budget, contract negotiation and oversight of vendor activities.
Manages the design and implementation plan of Medical Affairs program, including identification of critical paths, budget management and control and tracking of all projects.
Development and maintenance of a contact network with national and international thought Leaders.
Manages creation of educational, promotional and reporting materials for use by internal stakeholders.
Ensures review of promotional material.
Ensure collaboration with external companies in co-promoting our products.
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.
Ensures that every evidence generation activity is conducted according to all applicable guidelines, regulations, company procedures and high ethical/quality standards.
Ensures design and implementation of a publication plan, including preparation and review.
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.
Represent the local strategy and participate or ensure participation as member of the EMEA Medical Affairs Product Team (EMAPT) and co-create team.
Observe and promote 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.
Complies with own training requirements to perform duties of own job. Assure that all assigned personnel have the appropriate training and qualifications to perform all duties and responsibilities and ensure inspection readiness with respect to personal training compliance, and availability of recent CV and individualized job description.
Participates in the company's drug surveillance/product safety programs which includes following up on adverse reaction reports and Risk Management Plans.
Report 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 communicate it to the Pharmacovigilance Department.
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.
Set clear performance standards, provide feedback and coaching, and hold direct reports accountable for key deliverables.
Conduct annual performance reviews with direct reports to help support the creation of a diverse, high performing team.
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.
Be accountable for the development of succession plans for their Area.
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.
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.
Ensure inspection readiness with respect to personal training compliance, and availability of recent CV and individualized Job Description.

FAQs

What are the primary responsibilities of the Medical Affairs Therapeutic Area Leader in Oncology?

The primary responsibilities include developing and implementing medical affairs strategy, overseeing evidence generation activities, managing educational programs, collaborating with thought leaders, and leading the MSL plan.

What qualifications do I need to apply for this position?

Candidates should have a minimum of 5 years of experience in medical affairs or related roles, a university degree in medicine, science, or related fields, and fluency in English and Spanish.

Is there an emphasis on team management in this role?

Yes, successful experience in managing and developing teams while driving performance is essential for this position.

What type of evidence generation activities will I be responsible for?

You will be responsible for overseeing the design and implementation of evidence generation activities, including Phase IIIb, Phase IV trials, non-interventional studies, and real-world evidence projects at both local and regional levels.

Will I need to develop relationships with external specialists?

Yes, establishing and reinforcing professional relationships with national and international leading specialists is a key component of this role.

What languages are required for this job?

Fluency in both English and Spanish is required.

Is experience in oncology necessary for this position?

While deep knowledge of the therapeutic area is essential, the job description does not explicitly state prior oncology experience as mandatory. However, it is highly beneficial.

What is the importance of compliance in this position?

Compliance with regulatory requirements, company procedures, and ethical standards is crucial to ensure that all activities are conducted properly and safely.

Will I be involved in budgeting and financial management?

Yes, you will be responsible for managing the budget, contract negotiation, and oversight of vendor activities related to medical affairs programs.

How does this role contribute to the overall company goals?

This role supports the development and implementation of innovative healthcare solutions, aligning the medical affairs strategy with the company’s objectives in oncology and enhancing the impact on patient health.

Johnson & Johnson

Hospitals and Health Care

Science & Healthcare

Industry

10,001+

Employees

Mission & Purpose

Profound Change Requires Boldness. Johnson & Johnson is the largest and most diversified healthcare products company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world.