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Job Description - Medical Director/Senior Medical Director

Description: We are seeking a Medical Director or Senior Medical Director who will be based in our San Francisco office and primarily responsible for providing clinical oversight and interpretation of OXiGENE’s Phase 3 clinical trial in anaplastic thyroid cancer and Phase 2 trial in lung cancer. This individual would also play a key role in establishment and implementation of pharmacovigilance and safety monitoring. Reporting to the Chief Medical Officer, this position has responsibility for helping develop clinical strategy for oncology as well as implementation of the program. Specific responsibilities include designing and writing clinical protocols, medial monitoring of on-going trials, leading clinical and safety study report writing for regulatory submissions, and being a liason with opinion leaders in the field of oncology.

Responsibilities:

• Provides medical monitoring for ongoing clinical trials.
• Reviews and interprets clinical data on a real-time basis in collaboration with Oxigene clinical staff and vendors.
• Reviews and contributes to serious adverse event reporting.
• Participates in design and implementation of pharmacovigilance system.
• Responsible for the proper conduct of Safety Review Meetings for investigational drugs.
• Provides internal expertise in oncology to support strategic program planning.
• Leads and contributes to development of new clinical protocols.
• Serves on assigned project/product teams to provide guidance regarding medical/safety-related issues.
• Interact with various key opinion leaders in the field to support strategic planning and to identify appropriate investigators.

Qualifications: A MD degree is strongly preferred. Board certified or board eligible in oncology is desirable. At least 3-5 years clinical development experience in industry is strongly preferred, which should include some relevant oncology experience. Candidate must have fundamental understanding of drug clinical development, regulatory approval process, ICH and FDA GCPs, and US IND and NDA regulations. Candidate must have a working knowledge of pharmacovigilence; clinical safety regulations and guidelines, and clinical research trials methodology, design, implementation and analysis. The individual must possess outstanding communication skills with both in-house staff, outside physicians and external opinion leaders. Demonstrated leadership and problem solving skills, particularly in the field of clinical drug development, is critical.

To apply, please send your resume and cover letter to recruiting@oxigene.com.