Director Hta

**Director, Health Technology Assessment (HTA) & Decision Science (DS)**

We are currently recruiting for an Director HTA & Decision Science, within the Global Commercial Strategy Organization (GCSO), to be located in Raritan, NJ or Beerse, Belgium. This role will be in the HUB (Global Market Access & Commercial Strategy Operations) team and will support Health Technology Assessment & Decision Support across GCSO.

Janssen Global Services, L.L.C. (JGS) is a legal corporate entity encompassing a unique group of departments/organizations/teams that provide leadership across business-critical areas for J&J Innovative Medicine.

**Main deliverables for the role**
- **Development, implementation and consistent use of structured market access tools and processes **to ensure strong Target Product Profiles & “fit-for-purpose” clinical trial designs and to inform internal decision making.
- **Review of Clinical Trial Protocols at Protocol Review Committees **to ensure the robustness of the overall study designs and the optimal inclusion of patient, HTA and payer relevant PICOs elements (Population, Intervention, Comparator, Outcome) in protocols.
- **Maintain & further develop existing infrastructure and processes **to enable work and collaboration in a matrix organization.

**Job responsibilities**:

- **Development, implementation, and consistent use of structured market access tools and processes**: The Director HTA & DS will:

- be responsible for leading the continued development and further methodological evolution of existing market access tools as well as for exploring novel approaches, tools and instruments to assess and evaluate main areas of uncertainty & market access risks for key HTA markets and other critical markets including the US and Japan
- be responsible for evaluating likely HTA and payer outcomes based on anticipated evidence packages.
- be responsible for leading and driving the implementation & consistent use of internal processes and their adaptation to changing business requirements and for ensuring linkage to related relevant processes in the regions and Operating Companies, in collaboration with key business partners. He/ she will be responsible for ensuring clarity on roles & responsibilities of internal stakeholders.
- be responsible for developing & rolling out an internal training and certification program for the above-mentioned tools and processes.
- provide guidance and support for the evaluation of possible areas of uncertainty and risks for HTA agencies/ payers when using these structured tools. This guidance includes internal advice, assistance with consistent usage of tools & template completion and best practice sharing.
- lead the formal review of team’s assessments and evaluations.
- be responsible for setting up and for maintaining a system for institutional memory of teams’ evaluations.
- be responsible for developing internal metrics and key performance indicators and for setting up an internal reporting system/ dashboard.
- **Review of Clinical Trial Protocols at Protocol Review Committees**
- The Director HTA & DS will lead the technical and scientific expert functional Market Access review at designated PRCs to ensure the robustness of the overall study designs and the optimal inclusion of patient, HTA and payer relevant PICOs elements in protocols. The Director HTA & DS will work alongside other independent expert functional reviewers for at least two Protocol Review Committees organized by JJIM’s R&D organization.
- **Additional responsibilities include**:

- Maintain/ develop/ support the infrastructure and processes to support market access teams working in a highly matrixed environment.

**Critical attributes for the role**:
The Director HTA & DS will work closely with Global and Regional Compound/ Therapy Area Market Access leaders and the R&D clinical development teams as required. Expert insights into international HTA standards, the US and Japan healthcare system, R&D acumen, analytical and critical thinking, as well as the ability to lead and collaborate across diverse cross-functional and cross-regional teams are critical attributes for the role.

**Qualifications**:
**Experience, qualifications, skills and capabilities**:

- A postgraduate degree (e.g., MSc or PhD, PharmD, MD) in a relevant discipline (Epidemiology, Biostatistics, (Health) Economics, HTA, Medicine, Public Health) is required.
- A minimum of 7+ years of relevant experience in a pharmaceutical organization and/or external agency is required.
- Pharmaceutical Industry Experience: Experience with applied work in at least two of the following therapeutic areas: Oncology, Neuroscience, Immunology, Pulmonary Hypertension, Cardiovascular, and Ophthalmology is required.
- A strong R&D and Regulatory acumen, and experience with working closely with R&D incl. Regulatory Affairs for early and late-stage assets in global drug development is required.
- Balancing an expert understanding of the