The Opportunity:

This is an exciting opportunity to advance first-in-Class RAS(ON) Inhibitors through clinical development.  The ideal candidate is a strategic program management professional with deep experience leading cross-functional Companion Diagnostics (CDx) development activities supporting targeted oncology therapies. This individual will drive alignment across internal functions and external diagnostic partners to enable successful clinical development, regulatory execution, and commercialization readiness. The successful candidate will draw on their experience to:

• Lead cross-functional Companion Diagnostics development programs supporting clinical-stage oncology assets from assay strategy through clinical and regulatory execution.

• Work closely with CDx Leads and other clinical development team members to facilitate science-based CDx decision making and drive the execution of the CDx development strategy.

• Develop and maintain integrated cross-functional program plans, timelines, milestones, dependencies, and critical path analyses across internal teams and external diagnostic partners.

• Drive cross-functional alignment and coordinate CDx operational activities across Translational Medicine, Clinical Development, Regulatory Affairs, Biomarker Sciences, Clinical Operations, Alliance Management, and external diagnostics partners and vendors.

• Proactively identify program risks, resource constraints, and operational bottlenecks, and lead mitigation planning to ensure program execution and delivery.

• Facilitate program governance activities, including preparation of executive-level updates, program status reporting, risk escalation, and decision tracking.

• Partner with diagnostic partners and vendors and study teams to monitor execution against timelines, deliverables, and key milestones.

• Lead implementation of program management best practices, operational processes, and scalable planning tools to support growing Companion Diagnostics capabilities.

• Oversee implementation of clinical trial assays at reference labs and centralized testing vendors.

• Support strategic planning activities related to Companion Diagnostics portfolio execution, regulatory readiness, and commercialization planning.

• Influence cross-functional teams through data-driven recommendations, transparent communication, and structured problem-solving.

Required Skills, Experience and Education:

• B.A. or BSc. In Life Sciences with 8+ years of biotechnology, pharmaceutical, diagnostics, or clinical development experience, including 5+ years leading cross-functional drug development or Companion Diagnostics programs.

• Strong understanding of oncology drug development, biomarker strategy, assay development, clinical validation, and companion diagnostics regulatory pathways.

• Demonstrated success in leading complex cross-functional initiatives in matrixed environments with internal and external stakeholders.

• Strong strategic planning, risk management, and program governance skills.

• Ability to influence stakeholders and drive alignment across multiple functions and organizational levels.

• Excellent communication and executive presentation skills with the ability to synthesize complex information into actionable recommendations.

• Experience developing integrated timelines, managing dependencies, and driving execution across multiple workstreams.

• Strong motivation, attention to detail, ability to think independently and fully integrate into a high achieving team environment.

• Highly proficient using MS Office, Lucid Charts and Project Management software to manage project timelines and resources (e.g. MS Project, Smartsheet, Office Timeline, etc.).

Preferred Skills:

• MSc., MBA or advanced degree in related field preferred.

• Experience managing Companion Diagnostics or biomarker-driven development programs.

• PMP (Project Management Professional) or other PM certification or equivalent.

• Experience in Oncology therapeutic area and clinical stages of drug development. 

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