MEDICAL DIRECTOR – ONCOLOGY CLINICAL DEVELOPMENT – #2473
Our client company is a rapidly expanding global clinical stage biopharma company focusing on the discovery, development, and commercialization of innovative targeted Oncology therapies. The company has multiple assets in clinical development and a growing pipeline of innovative early-stage assets entering clinical trials globally, including multiple Phase I/II clinical trials in the US.
The Medical Director – Oncology Clinical Development (may be at the VP level) is responsible for providing the medical input and oversight for Oncology clinical development programs to advance the company’s clinical portfolio. Strategic responsibilities include designing and executing clinical development plans for oncology products from preclinical research, First in Human studies through Phase I/II/III Clinical Trials; engaging in medical dialogues with scientific and medical leaders for clinical data generation/interpretation/publication, managing effective relationships with Key Opinion Leaders and supporting Business Development activities.
Note: This position is home-based with a flexible work schedule and limited travel requirements.
- Collaborate with physicians, scientists, clinical trial operations, regulatory professionals, biostatisticians and others as necessary to plan and execute clinical trials from beginning to end to ensure speedy initiation and timely completion.
- Assume medical responsibility for clinical trials including active participation in real-time medical monitoring of studies, patient eligibility assessment, study design questions and safety data review.
- Conduct safety monitoring in collaboration with CRO pharmacovigilance group of active clinical studies.
- Analysis, interpretation, presentation and publication of clinical study data.
- Collaborate with colleagues in Regulatory Affairs, CMC, Toxicology, Research, Pharmacology to respond to health authority and ethics committee queries.
- Participate in clinical study report writing and review, using medical expertise to identify ways to best analyze and present data
- Contribute clinical expertise and content to regulatory documents (e.g. briefing books, INDs, NDAs, etc.) and represent Clinical team in discussions with Health Authorities
- Collaborate with Principal Investigators in the evaluation and assessment of publications (abstracts, posters, manuscripts) associated with clinical data.
- Network extensively to develop long-term strategic partnerships with thought leaders both internally and externally, in support of the company’s vision.
- Represent the company at medical meetings, advisory boards and outreach meetings as needed/appropriate
- Support Business Development activities.
- MD (or equivalent) with board certification or board qualifications in medical oncology.
- At least 5 years of clinical development experience within the pharmaceutical or biotechnology industry with focus and strong track record of experience with leading oncology clinical trial design and execution.
- Academic oncologists with clinical and research experience will be considered.
- Experience in protocol development, medical review, oversight of study conduct, running trials, key stakeholder engagement, data quality, and safety are strongly preferred.
- Strong working knowledge of the clinical drug development process in the conduct/participation in clinical trials and their subsequent publications.
- Successful academic research publication history or history of medical practice in Oncology
- Solid personal and professional relationships with key opinion leaders (KOLs) in medical oncology. Strong credibility within the US medical community which includes the ability to reach out to key thought leaders in academia.
- Fluent in written and spoken English with excellent communication skills is required.
*Resume Submission: You may apply online (click on the “Apply Online” box below) or contact the recruiter for additional information at: email@example.com Please reference job #2473. Thank you.