Location: Woodcliff Lake, NJ
The Sr. Director, GV&A – Oncology is a key role with client and provides strategic evidence generation, pricing/reimbursement and HEOR input to the Oncology Business Unit Leadership Team to ensure patient and payer-centric product development alignment.
The Snr. Director GV&A - Oncology will drive the development and alignment of value proposition strategies with clinical, regulatory, medical affairs, and commercial teams.
They will be responsible for the direction and the generation of evidence development to support reimbursement submission & decisions globally.
This responsibility extends to the Value and Access Strategies for all client oncology products, all indications (Halaven MBC &STS, Lenvima RRDTC, RCC, HCC) as well as all potential new products and indications in the client pipeline. In collaboration with Global Market Access Director; the Snr Director GV&A - Oncology will support reimbursement activities for all oncology products in all markets.
The Sr. Director GV&A - Oncology will report to the Executive Director of GV&A with a dotted line reporting to the Chief Clinical Officer.
The Sr. Director GV&A - Oncology will also have managerial responsibility for direct reports within the Oncology GV&A team and have oversight of their direct reports’ roles, responsibilities and deliverables
- Drive alignment across complex matrix of clinical, medical affairs, commercial and value & access functions as well as local country affiliates to deliver an integrated global payer perspective.
- Serve as the subject matter expert on HEOR, PRO, pricing and reimbursement at the leadership team and provide key input the clinical development plan and global regulatory plans.
- Collaborate internally with clinical development, biostatistics, and medical affairs to ensure that strategically appropriate payer- and patient- relevant endpoints are include in phase 2-4 trials. Critically assess every protocol and provide recommendations on study designs, comparator selection and outcomes measures.
- Create and implement Patient Reported Outcomes strategy: recommendation for PRO selection in clinical trials, PRO SAP, FDA/EMA PRO submissions, utility analyses and publications.
- Provide HEOR and P&R input to development and launch teams.
- In collaboration with Clinical, Medical Affairs and Regulatory Affairs, develop clinical strategy early in product development that support leveraging knowledge of the external policy and decision maker environment, enabling more efficient evidence development and /or optimizing demonstration of differentiation for both discovery assets and later medicines in development broad market access.
- Work with commercial areas and clinical affairs to gather feedback from key opinion leaders and understand global reimbursement pathways; Lead cross functional initiatives and collaborate with Medical Affairs, Clinical, R&D, local Market Access and Affiliates to ensure solid understanding of global payer markets and emerging stakeholders in the reimbursement area and translate reimbursement requirements into product specifications and assess potential reward and risk.
- Provide estimates of pricing & reimbursement expectations and necessary future HEOR investments for business development reviews and existing products.
- Monitor healthcare legislative changes and proactively modify product reimbursement and market access plans to manage; communicate impact and recommendations to the leadership team
- Drive high quality evidence generation methodologies and execution of timely deliverables for the Oncology BU, in collaboration with Clinical Development.
- Develop comprehensive outcomes research plans to identify and address evidentiary gaps for pricing and reimbursement submissions, patient-reported outcomes submissions, and health policy submissions.