Associate Vice President, Companion Diagnostics (Cheyenne)

Associate Vice President (AVP) / Companion Diagnostics

The Associate Vice President (AVP) / Companion Diagnostics will be responsible for leading the diagnostics strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development. The successful candidate will have an essential strategic and tactical role in overseeing the scientific direction of companion diagnostics (CDx). Specifically, the Diagnostics Lead will develop and execute diagnostic strategies and interact with various stakeholders to ensure alignment with clinical development timelines and regulatory requirements. Most importantly, the role requires overseeing CDx development, ensuring timely delivery of CDx solutions for pharmaceutical registration and launch. This individual is expected to stay up to date regarding industry trends and diagnostic regulatory requirements.

Essential Job Requirements :

• Develop end-to-end diagnostic strategy in collaboration with key stakeholders and ensure alignment with clinical development strategies and timelines.
• Interact early with Discovery to understand the predictive hypotheses to be tested for specific programs and develop assays to reflect these hypotheses. Collaborate with internal research capabilities or external vendors to develop a predictive assay if not already available.
• Interact at all stages with Early Development and Late-Stage stakeholders to ensure strategic alignment.
• Conceive and develop CDx strategies for clinical development programs and obtain endorsement from various governance bodies.
• Oversee the CDx team, ensuring coordination of strategy and execution as well as career development of team members.
• Therapeutic focus will initially predominantly be in the Oncology Therapeutic Area, with a plan to expand into other therapeutic areas such as immunology, neurology, cardiometabolic and others as needed by the pipeline.
• Work with Regulatory Affairs to ensure that regulatory documents (e.g., IDEs, PMAs, etc.) are delivered and communicate with health authorities when required.
• Oversee the CDx development and ensure timely delivery of CDx solutions for pharmaceutical registration and launch.
• Communicate updates to, and seek feedback from, cross-functional stakeholders surrounding the progress of the CDx program.
• Stay up to date with industry trends, technology advancements, and regulatory requirements for diagnostic assays.
• Drive diagnostic product innovation and improvement through both in-house R&D efforts and in collaboration with diagnostic partners.
• Participate in other training, supervisory and management activities as required by the company.

Education :

Other Qualifications :

Salary Range : $250,800.00 - $394,800.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https : / / jobs.merck.com / us / en / compensation-and-benefits.