Johnson & Johnson

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Originele vacaturetekst

Medical Therapeutic Area Lead Cell & Gene Therapy Benelux

Job Description

At Janssen, we are dedicated to addressing and solving some of the most substantial unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.

Motivated by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen is a pharmaceutical company of Johnson & Johnson.

Janssen is looking for a Medical Therapeutic Area Lead Cell & Gene Therapy Benelux based in either Breda, Netherlands or Beerse, Belgium.

The Medical Affairs Therapeutic Area Lead is the medical leader within the assigned therapeutic area (TA) and manages the TA’s Medical Affairs team. Acts as the proactive strategic partner within the Cluster Value Team (CVT) for medical excellence in his/her assigned TA. In this role the Medical Affairs Therapeutic Area Lead acts as a bridge between the Benelux and the EMEA Medical Affairs organization in building the CVT’s strategy and providing Benelux level insights for the EMEA Medical Affairs strategy. MDs will also be involved in patient related issues, both for in label as trial compounds (see addendum).

The Medical Affairs Therapeutic Area Lead reports to the the Medical Director Benelux, who is a member of the Management Board. The Medical Affairs Therapeutic Area Lead has people management responsibilities, leading one (or more) Medical Advisors (MAs) and Medical Science Liaisons (MSLs). The Medical Affairs Therapeutic Area Lead is the scientific partner to the business, thus supporting the overall company business goals. The Medical Affairs Therapeutic Area Lead is expected to lead changes in organizational behaviors to successfully implement a medical deployment for a specific therapeutic area in line with the Cluster Value Team’s expectations.

Tasks and responsibilities

The function of Medical Affairs Therapeutic Area Lead contains the following main tasks & responsibilities:

Shape CVT Planning & Strategy, based upon medical insights and data gathered in the field

• Translate information and insights of the relevant TA treatment framework from internal and external stakeholders into strategy and plan for implementation

• Build a wide network internally and thus contribute to multi-disciplinary (research & development, marketing, health economics/market access/reimbursement (HEMAR)) strategies

• Proactively explore needs for evidence generation, make strategic choices for delivery of evidence (outcomes, methods, internal & external collaborations) and apply insights for new value propositions for the therapeutic area and the business

• Take on role of Study Responsible Physician/Scientist (SRP/SRS) where applicable

• Represent the full medical domain (including Q&C, RA, PV, QA, Medical Information) within the CVT for his/her TA

• Ensure that CVT strategy is aligned with regional (EMEA) and adapted in the local strategy

Develop and ensure execution of MAF contribution to CVT strategic plan

• Responsible for the management of the Benelux TA Medical Affairs (MAF) team and the delivery on target

• Responsible for continuous learning programs internally

• Shape the CVT strategic plan in line with the overall MAF strategy.

• Implement activities and measure performance based upon the predefinied KPIs and matrix of Medical Affairs

• Discuss and align the Medical Affairs contribution to the CVT plan, EMEA Medical Affairs Functional Network and MAF mission and priorities

• Manage MAF budget for his/her TA, including resource allocation

• Take personal actions to ensure that medical affairs function is a valued partner of commercial teams through effective internal communication, participation in senior management meetings, engagement and promotion of medical contributions

• Ensure high quality medical input is provided to regional brand teams to ensure appropriate strategies are developed for the region

Build & maintain TA leadership and stakeholder network

• Build and maintain a strategic overview of the external health care environment

• Build an external network as a strategic representative to external bodies

Keep abreast of medical and scientific knowledge

• Continuously update knowledge of products, patient treatment trends and clinical activities and studies within the TA and patient treatment trends in the region

• Identify evolving scientific concepts with future clinical implications

• Considered and recognized as a trusted scientific counterpart and a partner

Ensure medical quality & consistency

• Final responsibility for the quality and consistency of medical content within TA

• Ensure the correct use of products within his/her TA

Ensure team compliance

• Maintain compliance with local and EMEA standard operating procedures (SOPs); document training and maintain personal binder according to SOPs

• Ensure compliance with regulatory requirements and with company policy on business integrity

• Ensure safety reporting requirements (timely AE/PQC reporting) as set out in company policies and SOP’s (Standard Operating Procedures) are met and appropriately managed when planning projects, developing materials, executing projects and contracting vendors

• Ensure HCC and legal requirements are fully understood, appropriately managed and complied with when planning projects, developing materials, executing projects and contracting vendors.

People management

The Medical Affairs Therapeutic Area Lead manages one (or more) Medical Advisors (MAs) and (senior) Medical Science Liaisons (MSLs):

• Develop and manage performance, including goals & objectives through “5 conversations”

• Manage the MSL(s)/MA(s) and provide leadership support to MSL(s)/MA(s)

• Act as coach and ‘sounding board’ to individual MSL(s)/MA(s)

• Develop and review individual development plans of MSL(s)/MA(s)

• Build and develop one TA team with all individual professionals

• Lead effective succession planning and develop a talent pipeline for medical affairs functions

• Support and coach the team in preparing discussions with customers to develop studies that will fulfil global and local business strategies

Additional Chapter for MDs in the position of Medical Affairs Therapeutic Area Lead (see also addendum)

• Investigate side effects of individual patients reported for in label compounds but also in clinical research

• Respond to medical questions of HCPs related to use of medication of individual patients ( like off-label use, contra-indications, interactions etc)

• Evaluate individual patients profile before participating in a ‘ named patient program’ .

• Involved in clinical research

The Medical Affairs Therapeutic Area Lead will lead the Medical Affairs within his/her TA for the Benelux, and in this role can have ‘virtual’ people management responsibilities as an overall orchestrator of different medical disciplines

BIG registration

This section is only applicable to employees trained as physician which are registered in the Dutch BIG register. Employees trained as physician should be registered in the BIG register and need to make sure that their license is renewed every 5 years in line with the requirements of the Dutch government/BIG register. Janssen facilitates an average of 8 hours a week of individual patient care or equivalent activities to meet these requirements. The following tasks classify as execution of “individuele gezondheidszorg”, in line with the obligation set by the ministry of Health for qualification for the Dutch BIG register.

Business/customer support (pre and post launch support)

• Assessment of adverse events of individual patients, which are reported during the use of registered medication during daily practice.

• Answer of medical questions of Health Care Providers of patients about the use of medicines (off-label indications, dose adjustments, contra indications, precautions, warnings and interactions)

• Assess patient participation in SPRs, named patient programs and compassionate use programs

• Answer medical questions from patients and health care providers concerning products and discuss patient cases with Health Care Providers

• Discuss patient cases with Health Care Providers for individual patient treatment advice on appropriate use of medication

• 24-hour emergency call duty for urgent questions from patients and physicians

Clinical Research/Trial Execution and Support

• Assess patient or volunteer participant eligibility for participation in clinical research trials

• Conduct and treat patients or volunteer participants during clinical research trials

• Assessment of (serious) adverse event and observations during clinical research trials

• Advise about treatment of (serious) adverse events during clinical research trials

• assess clinical cases of individual patients or volunteer participants in clinical research trials reported in the clinical monitoring reports

• monitor patient safety during the conduct of clinical research trials and conduct the appropriate tracking and follow up of adverse events, in alignment with corporate patient safety policies and procedures

• Provide medical information to Health Care Providers, patients and volunteer participants in clinical research trials (protocol, patient and informed consent information)

• Investigator Initiated Trials: involvement to assess the patient eligibility according the entry criteria


Profile / Qualifications / Experience

For the function Medical Affairs Therapeutic Area Lead the following qualifications are required:

• Scientific degree: Medical Doctor, pharmaceutical or biomedical degree or equivalent by experience

• More than 4 years experience within Medical Affairs in the pharmaceutical industry

• Experience in managing the organization and business operation in the division/department

• Proven strong analytical, communication, influencing, decision-making and leadership skills for interaction with external and internal stakeholders

• Deep understanding of local regulatory policy and industry’s code of practice related to drug registration, pharmaceutical promotion and clinical studies

• Conceptual skills: able to have an integral view across different disciplines within the medical domain for the therapeutic area

• Able to represent the medical domain in its broadest sense (including Medical Education, Regulatory Affairs (RA), Pharmacovigilance (PV), Quality Affairs (QA); an orchestrator beside being an expert in his/her field

• People management and team leadership skills: stimulate and motivate to develop and execute medical excellence and medical leadership

• Conceptual skills: able to have an integral view across different disciplines within the medical domain for the therapeutic area

• Languages: Dutch, English: spoken & written; notion of French

The following qualifications are preferred:

• Experience in managing professionals in the pharmaceutical or related industries

• Preferred Business acumen and relevant experience/ training in business administration for translation into strategy

• Knowledge of the therapeutic area

• Understanding of Clinical Study operations and execution is preferred


Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location
Netherlands-North Brabant-Tilburg-
Other Locations
Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Janssen-Cilag Netherlands (8345)
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