Executive Medical Director
Our client is a clinical stage biopharmaceutical company. They have asked us to assist them in a search for an Executive Medical Director
The Executive Medical Director will provide clinical leadership within the company in critical projects and will be a crucial link with investigators and key opinion leaders in the external oncology community. The incumbent will work closely with these experts, developing the clinical trial strategy and designing clinical trials. This individual will serve as a key strategic and medical point person during the conduct of the trials, monitoring safety of ongoing trials and leading efforts to analyze and present data from clinical studies. The successful candidate will work closely with other physicians, scientists, regulatory professionals, statisticians and internal stakeholders to carry out these responsibilities. This individual will respond to inquiries by practitioners and investigators, IRBs, regulatory bodies, and vendors.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Provides clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program.
- Collaborates with physicians, scientists, regulatory professionals, biostatisticians, regulatory, executive staff and others as necessary to develop and execute clinical trials from beginning to end.
- Drives clinical trial execution to achieve timely completion of clinical studies in collaboration with clinical teams.
- Assumes medical responsibility for clinical trials including active participation in real-time medical monitoring of studies, including patient eligibility assessment, study design questions and safety data review.
- Conducts safety monitoring in collaboration with CRO pharmacovigilance group of active clinical studies.
- Ensures consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations, and laws.
- Collaborates with colleagues in Regulatory Affairs, CMC, Toxicology, Research, and Pharmacology to respond to health authority and ethics committee queries.
- Participates in clinical study report writing and review, using medical expertise to identify ways to best analyze and present data.
- Designs and develops clinical study protocols and associated clinical study documents and contributes to program level documents such as Investigator Brochures and Clinical Development Plans.
- Performs functions in compliance with GCP, and good medical practice.
- Collaborates with Principal Investigators in the evaluation and assessment of publications (abstracts, posters, manuscripts) associated with clinical data.
- Networks extensively to develop long-term strategic partnerships with thought leaders both internally and externally, in support of the company’s vision.
- Medical degree (or equivalent) with board certification or board qualifications in medical oncology is required.
- Board certification/eligibility and clinical experience in oncology or hematology/oncology highly preferred.
- Must have a minimum of 3 years of clinical development experience within the pharmaceutical or biotechnology industry with a focus and strong track record of experience leading oncology clinical trials.
- Academic oncologists with clinical and research experience relative to the oncology platform will be considered.
- Strong working knowledge of the clinical drug development process is required.
- Must have a solid understanding of the clinical landscape relevant to oncology patients and health care practitioners in the field.
- Requires a track record in the conduct of/participation in clinical trials (investigator initiated, company sponsored or cooperative group trials) and their subsequent publications.
- Requires strong credibility within the US medical community including the ability to reach out to key thought leaders in academia.
- The demonstrated ability to work in a matrix environment with cross-functional teams is required.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.