Director, Precision Medicine and Companion Diagnostics

The Opportunity:

To aid in this mission, the Translational Medicine (TM) team at RevMed is seeking a highly motivated, scientifically creative, and collaborative Director to work in a fast-paced environment within a cross-functional team. This role will be the Translational Medicine lead for precision medicine and companion diagnostic (CDx) development for RAS(ON) inhibitors across different solid cancer types. Activities will be centered around analytical and clinical validation of CDx tests to support global regulatory submissions.

Responsibilities:

• Drive the development and implementation of CDx strategies to support early and late-stage development of portfolio assets through registration and launch for individual clinical studies and/or molecule program.

• Lead or participate in joint project teams (JPTs) with diagnostic partners and internal cross-functional team members to ensure successful execution of analytical and clinical validation studies.

• Effectively collaborate with biomarker scientists, biomarker operations, clinical development, and clinical operations, to ensure successful collection and CDx testing of clinical trial samples.

• Collaborate closely with diagnostic partners and internal functions, including biostatistics, data management, medical writing, regulatory, and project management to enable analytical and clinical validation required for regulatory submissions and CDx approvals in global market.

• In working with functional head and finance, manage contracts, budgets, and timelines of key milestones associated with CDx development.

• Collaborate with clinical development and medical affairs to develop plans for publication of diagnostic test results in identifying biomarker-positive patient populations.

• Collaborate with commercial colleagues to develop patient identification strategies (e.g. access to diagnostic tests) for launch readiness.

Required Skills, Experience and Education:

• Highly experienced biomarker or diagnostics professional, PhD with 6+ years or MS with 10+ years of relevant industry experience with expertise in companion diagnostic development and/or clinical oncology biomarker.

• 3+ years of experience in CDx development is required.

• Direct the development, outsourcing and validation of clinically applicable in vitro diagnostic assays through the development lifecycle of molecules, including design, implement and oversee diagnostic testing and registration strategy and timely communication with key internal and external stakeholders.

• Provide expertise to development project team to ensure access to stat-of the-art approaches on fit for purpose diagnostic technologies employed in clinical development (e.g. NGS-based tissue and ctDNA assays, PCR, immunohistochemistry) are required.

• Experienced and serve as subject matter expert in diagnostic regulation and support the interactions with global health authorities regarding companion diagnostics development and submissions.

• Excellent scientific and business communication skills, strong interpersonal/collaboration and planning skills including influencing without authority.

• Ability to think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems in a fast-pace innovate environment.

• A great teammate, who listens effectively and invites response and discussion.

• Commitment to Revolution Medicines’ Core Values: Tireless Commitment to Patients, Transformative Science, Exceptional Together, Total Integrity, Inclusiveness and Fairness.

Preferred Skills:

• Experience in oncology drug development in the biopharmaceutical industry is preferred.

• Cross-functional experience in commercial and or medical aspects of companion diagnostics is a plus.

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