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United States
Remote only
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Executive Director, Global Medical Affairs Companion Diagnostic Lead based in the United States.
This senior leadership role will shape and execute global medical affairs strategies for companion diagnostics (CDx) supporting oncology programs.
You will work across Global Medical Affairs, Clinical Development, Commercial, Biometrics, Clinical Operations, and Translational Research.
The position offers the opportunity to influence CDx strategy from clinical development through launch and post-launch evidence generation.
You will lead evidence-generation initiatives, including clinical and real-world studies, while helping optimize diagnostic adoption and utilization.
The role also involves engaging leading oncologists and pathologists to inform strategy, address barriers, and identify future evidence needs.
As a global cross-functional leader, you will contribute to launch readiness, scientific communications, training, publications, and external partnerships.
The position is remote within the United States, with approximately 25% travel and substantial collaboration across global teams.
Develop and execute a global Medical Affairs strategy for companion diagnostics, aligning it with broader medical and clinical development strategies.
Lead cross-functional planning for successful CDx development, launch readiness, and ongoing program execution.
Generate and oversee clinical and real-world evidence, including investigator-initiated studies, testing-utilization studies, diagnostic accuracy studies, and clinical utility studies.
Partner closely with disease-area medical leads to integrate CDx strategies into broader medical strategies.
Lead data-generation activities involving laboratory-developed tests (LDTs) and follow-on CDx testing, ensuring alignment with global strategy.
Provide global and regional insights on pipeline programs requiring companion diagnostics and help inform future development strategies.
Establish and maintain relationships with key opinion leaders in oncology and pathology to support CDx strategy, launch preparation, evidence generation, and utilization.
Collaborate with Commercial and other functions to support market-launch readiness and ensure alignment across CDx activities.
Gather external expert feedback on barriers to CDx adoption and opportunities to optimize testing and companion-drug utilization.
Identify and validate future evidence-generation priorities through engagement with oncologists, pathologists, and other experts.
Develop and deliver appropriate CDx training for medical and field teams.
Support scientific publications and provide medical review of diagnostic materials and communications.
Represent Global Medical Affairs in relevant alliance partnerships when appropriate.
Establish, track, execute, and report against program goals, objectives, budgets, timelines, and deliverables.
Support budget planning and management while maintaining compliant business practices.
Contribute to the development and implementation of relevant standard operating procedures and policies.
Advanced scientific or medical degree such as MD, PharmD, PhD, or equivalent, with subspecialty training in oncology.
Extensive pharmaceutical or biotechnology experience in solid tumors, including at least 8 years of relevant industry experience.
Clinical experience in solid-tumor oncology combined with prior companion diagnostic medical experience.
Previous Medical Affairs experience involving companion diagnostics is strongly preferred.
Demonstrated expertise in biomarker incorporation and companion diagnostic development within global clinical studies.
Deep understanding of laboratory-developed tests and the evidence requirements supporting CDx launches and companion-drug utilization.
Strong knowledge of GCP and ICH guidelines and familiarity with industry-standard clinical development technology solutions.
Experience developing or supporting relevant SOPs, policies, and compliant processes.
Exceptional written and verbal scientific communication skills, with the ability to translate complex scientific information clearly for diverse audiences.
Strong interpersonal, organizational, problem-solving, risk-mitigation, and cross-functional collaboration capabilities.
Executive presence with the ability to influence stakeholders, build alignment, and lead through complex global initiatives.
Demonstrated strategic leadership and, preferably, experience building, managing, and developing individuals or teams.
Results-oriented approach with strong analytical and data-analysis capabilities.
Ability to work effectively with geographically distributed, multicultural teams and adapt to changing priorities.
Collaborative, proactive, entrepreneurial, and continuous-learning mindset.
Willingness to travel approximately 25% of the time.
Annual base salary range of $296,600–$376,600, with actual compensation determined by factors such as experience, qualifications, skills, education, and work location.
Eligibility for an annual bonus plan for non-commercial roles.
Potential discretionary equity awards and access to an employee stock purchase plan.
Comprehensive medical, dental, and vision coverage.
401(k) retirement plan.
Flexible Spending Account (FSA) and Health Savings Account (HSA) options.
Life insurance coverage.
Paid time off.
Wellness benefits and programs.
Remote work arrangement within the United States.
Opportunity to work in a global, cross-functional oncology environment with approximately 25% travel.
