Scientific AVP, Oncology Diagnostics

Job Description

The Associate Vice President (AVP)/ Oncology Diagnostics will be responsible for leading the oncology 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.

• Conceive and develop CDx strategies for clinical development programs and obtain endorsement from various governance bodies

• 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:

• PhD required

• MD or MD/PhD is a plus

Required Experience and Skills:

• 10+ years of industry experience in clinical biomarker testing and CDx development.

• Deep understanding of scientific concepts, clinical development processes, clinical testing guidelines, and the regulatory requirements for diagnostic products and CDx.

• Ability to identify key information and make data driven decisions.

• Ability to use critical and strategical thinking to handle complex or ambiguous situations.

• Ability to articulate facts, ideas, and strategies in all communication formats.

• Ability to set and manage stakeholder expectations, ability to influence without authority.

• Ability to work effectively in a matrixed environment, ability to manage cross-functional teams.

Travel:  up to 25 %

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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