Executive Director, Global Medical Affairs – Companion Diagnostic Lead

This is a fully remote position, open to applicants in United States.

📋 Description

• Formulate a comprehensive Global CDx medical Affairs Strategy.

• Assist in the execution of a cross-functional plan aimed at successful CDx launch initiatives.

• Generate clinical and real-world evidence (e.g., IITs, testing utilization studies, diagnostic accuracy studies, clinical utility studies).

• Collaborate closely with the GMA disease lead to align the CDx strategy with the overarching Medical Strategy.

• Lead and supervise data generation efforts utilizing LDTs for follow-on CDx testing, ensuring alignment with the global CDx strategy.

• Provide global (including regional) insights into pipeline programs that require CDx.

• Engage key opinion leaders (KOLs) in pathology and oncology to facilitate the successful launch of CDx.

• Offer cross-functional support for market launch readiness, in sync with commercial CDx activities.

• Gather feedback and insights from KOLs (oncologists and pathologists) to reduce barriers and enhance the utilization of CDx, while validating future data generation requirements.

• Conduct internal training sessions for medical and field teams, ensuring appropriate training on CDx.

• Assist in the preparation of scientific publications.

• Provide medical review of diagnostic materials (e.g., PRC, MRC, etc.).

• Act as the GMA representative in Alliance partnerships when appropriate.

• Develop, monitor, execute, and report on goals and objectives.

• Aid in budget planning and management.

• Ensure adherence to compliant business practices.

⛳️ Requirements

• An advanced degree (MD, PharmD, PhD, or MD equivalent) with specialized training in oncology.

• Significant experience in the pharma/biotech sector focusing on solid tumors is required.

• Over 8 years of experience within another biotech/pharmaceutical organization.

• Clinical experience in solid tumor oncology and previous CDx medical experience is essential for this role.

• Prior experience in Medical Affairs in a CDx capacity is highly preferred.

• Expert knowledge of biomarker integration and CDx development in global clinical studies.

• Profound understanding of LDTs and the scope of data generation to support CDx launches and companion-drug utilization.

• Excellent communication (both written and verbal), interpersonal, organizational, and cross-functional collaboration skills.

• Familiarity with GCP and ICH Guidelines.

• Willingness to collaborate with colleagues in a global environment.

• Ability to undertake work-related travel approximately 25% of the time.

• Strategic leadership capabilities with a proven track record in building, managing, and developing individuals and teams are preferred.

• Experience in developing and supporting related SOPs and policies is expected.

• Knowledge of industry-standard Clinical Development IT solutions is anticipated.

🏝️ Benefits

• Medical

• Dental

• Vision

• 401(k)

• FSA/HSA

• Life Insurance

• Paid Time Off

• Wellness