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J&J Family of Companies Associate Director/Director, Health Technology Assessment (HTA) & Decision Support (DS) (2 positions) in Beerse, Belgium

Associate Director/Director, Health Technology Assessment (HTA) & Decision Support (DS)

The Associate Director/Director, Health Technology Assessment (HTA) & Decision Support (DS) will be part of a team that is responsible for ensuring the successful design of clinical trials and clinical development programs across the Janssen portfolio to meet the needs of increasingly evidence-driven and cost-conscious HTA agencies around the world.

The role involves a broad understanding of clinical trial methodology and regulatory requirements (e.g. International Conference on Harmonization), HTA requirements (e.g EUNETHTA Core requirements), for both relative effectiveness (endpoint relevance, systematic reviews, meta analyses, and use of observational studies) as well as cost-effectiveness (QALYs & modelling). Job responsibilities cover a number of key related activities:

  • Formal Early Scientific advice with HTA agencies: Formal early scientific HTA advice is increasingly used by Janssen to inform clinical development, evidence generation and submission decisions. The Associate Director/Director HTA & DS supports the Early Scientific HTA Advice Committee (ESHTAC), a cross-organizational, cross-functional committee that ensures timely, consistent and high-quality approaches to early HTA advice across Market Access, Regulatory Affairs and R&D. Activities include:

  • Practical support to teams with preparation of briefing books, contingency planning, meeting rehearsals, debriefs and minutes

  • Maintaining organizational infrastructure including inventory of agencies’ early advice submission guidance’s and templates, and internal institutional memory of teams’ submissions and advices.

  • Helping ensure organizational learning with cross-organizational structured dissemination of key learnings.

  • Protocol Review Committees: The Associate Director/Director provides technical and scientific review to ensure the robustness of the overall study designs and the optimal inclusion of patient and payer relevant elements in protocols (inclusion & exclusion criteria, comparator choice, endpoint battery, and other aspects of study design). The Associate Director works alongside other independent expert functional reviewers for one or more Protocol Review Committees organized by Janssen’s R&D organization.

  • Structured tools and processes: Ensuring strong Product Profiles and structured assessment of likely HTA outcomes is necessary for Janssen’s Design for Access strategy. The Associate Director/Director will support the evaluation of possible areas of uncertainty for payers with clinical development programs using structured tools. This support includes advice, assistance with template completion, ensuring consistent use and thoughtful assessments, and internal institutional memory of teams’ evaluations.

  • Health Technology Assessment Capability Support: The Associate Director/Director helps maintain an up-to-date inventory of key HTA agencies’ submission requirements and identifies key trends in HTA methods, submission requirements and decisions. This includes partnering with global, regional and operating company market access colleagues to consolidate key insights and best practices for existing and emerging value frameworks. The role also supports benchmarking, development of relevant strategic briefings, externally facing position documents and responses to external agency initiatives.

Critical attributes for the role: The Associate Director/Director will work closely with Global Compound Market Access leaders and the R&D clinical development teams as required. Strong insights into international HTA standards, strategy development, intellectual curiosity, creativity as well as the ability to collaborate across diverse cross-functional and cross-regional teams are critical attributes for the role.

Additional responsibilities include: supporting the infrastructure and processes to support market access teams working in a matrixed environment and capability development through tools, communities of practice, etc.

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Qualifications

Required Minimum Education: A postgraduate degree (e.g., MSc, PhD, MD, PharmD) in a relevant discipline (Epidemiology, Biostatistics, Health Economics, Economics/Commerce, Medicine, Public Health) is required.

Required Years of Related Experience: Level is dependent on skills and experience. A minimum of 4+ years for Associate Director and 7+ years for Director of relevant experience in a pharmaceutical organization or external agency is preferred.

Required Knowledge, Skills and Abilities: Balancing an expert understanding of the reimbursement requirements and HTA review processes for key international markets with strong understanding of regulatory authority processes (e.g. International Conference on Harmonization), and drug development is required.

The successful candidate will have strong written and oral communication skills with the ability to communicate complex material and be able to demonstrate collaboration and teaming skills while working within cross-functional international teams.

Preferred Related Industry Experience: Experience with applied work in one or more of the following therapeutic areas: Oncology, Infectious Diseases & Vaccines, Neuroscience, Immunology, Pulmonary Hypertension, Cardiovascular & Metabolism, and Ophthalmology is preferred.

Experience with preparing and supporting HTA and reimbursement submissions is an advantage.

Knowledge of and experience with systematic reviews, cost-effectiveness modelling and observational studies (RWE) respectively are advantages.

Experience with working closely with R&D, Regulatory Affairs and other colleagues for early as well as late stage assets in global drug development is an advantage.

A global mindset and cross-functional and cross-regional team collaboration is a must.

Location(s)

Raritan (NJ) and Beerse (Belgium). Some international travel is required

Primary Location

Belgium-Antwerp-Beerse-

Other Locations

North America-United States-New Jersey-Raritan

Organization

Janssen Pharmaceutica N.V. (7555)

Job Function

R&D

Requisition ID

00001G24

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