Medical Director I - Oncology - Remote
Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.
We’re looking for an exceptional Medical Director I to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.
At Premier Research, we are science-minded and heart-centered. Join us.
We are looking for the best of the best!
The Medical Director – Oncology is responsible for providing the medical and ethical input and oversight for Oncology studies conducted by Premier Research. Strategic responsibilities include design and execution of clinical development plans for oncology products, from preclinical research through Phase I/II/III/IV clinical trials; engaging in medical dialogue with scientific and medical leaders for clinical data generation/interpretation/publication, managing effective relationships with Key Opinion Leaders and supporting Business Development activities.
This position offers an opportunity to learn the ways of the Pharmaceutical industry for oncologists without such experience.
Note: This position is home-based with a flexible work schedule and limited travel requirements.
You'll be doing:
- Collaborate with other physicians, scientists, clinical trial operations, regulatory group, 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
- Prepare/present educational materials for internal and external customers
- Support Business Development activities.
- MD with board certification or board -eligible in medical oncology, hematology or radiation oncology
- Academic oncologists with clinical and research experience are preferred, industry experience is not necessary, but appreciated.
- Experience in protocol development, medical review, oversight of study conduct, running trials, key stakeholder engagement, data quality, safety as well as good working knowledge of the clinical drug development process are desired.
- Successful academic research publication history or history of medical practice in Oncology
- Fluency in written and spoken English with excellent communication skills is required.