We have a current opportunity for a Executive Medical Director, Oncology on a permanent basis. The position will be based in Seattle.
Key Responsibilities
Provides medical/scientific, strategic and operational expertise and support for the planning and execution of IND filings, early and late stage clinical trials.
Provides expert opinion on the pathophysiology and diagnosis of disease, existing and emerging treatments and unmet medical needs to inform key medical and business decisions.
Conducts medical monitoring of clinical trials; writes protocols, informed consent documents; responds to questions from regulatory agencies, institutional review boards and ethics committees; reviews clinical data, case report forms and ensures final accuracy of clinical trial data for clinical study reports.
Conducts safety monitoring, oversees conduct of clinical sites for adherence to both company standards, and government/industry regulations (GCP/ICH); supports development of investigator brochures; trains investigators and travels to clinical sites to build relationships with investigators and study teams in support of study enrollment.
Institutes and continuously improves operating procedures ensuring best practices.
Establishes appropriate strategic partnerships with centers of excellence, advocacy groups and KOLs in the areas of scientific interest.
Collaborates closely with key stakeholders to ensure tight strategic integration of product development plans and strategies. Plans and develops content for advisory meetings with opinion leaders and for medical symposia.
Participates in review of medical materials to ensure content is medically appropriate and compliant with internal and external requirements.
Keeps up to date on current relevant therapeutic areas through familiarity with literature, attendance at meetings, conventions and professional associations.
Qualifications and Experience
MD or equivalent, with a minimum of 8 years of biotech or pharmaceutical experience in oncology drug development. Oncology fellowship training and Oncology certification preferred.
For further information about this position please apply.