Medical Director, Medical Affairs (Oncology)
Description
Premier Research is looking for an Medical Director, Medical Affairs - Oncology to join our Medical Management team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
- We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- We are Built by You. Your ideas influence the way we work, and your voice matters here.
- We are Built with You. As an essential part of our team, you help us deliver medical innovation that patients are desperate for.
Together, we are Built for BiotechSM. Join us and build your future here.
What you'll be doing:
- Provides medical leadership, medical/safety monitoring, and pharmacovigilance tasks for assigned projects and therapeutic areas
- Provides expert advice and detailed clinical development strategies and consultation for allocated projects, including protocol development, study design, marketing materials, investigator brochure development, regulatory strategy and submission, and study execution strategies
- Reviews Medical/Scientific Data as requested from Premier Departments e.g. CTM, Biometrics and provides coverage for other colleagues within Medical Affairs as needed.
- Offers mentoring as well as, both general scientific and therapeutic training, including preparation of training materials for account managers and other relevant personnel.
- Liaises with both internal and external experts, including attending client meetings, scientific/industry meetings and leveraging strategic collaborations as needed, to serve the best interest of the client and produce high quality clinical development programs and other deliverables.
- Provides expert input on RFP/RFI, including (but not limited to) therapeutic overview, executive summary, patient recruitment, strategy and protocol considerations and study execution strategy as needed.
What we are searching for:
- Degree of Medicine; MD, MBBS, DO or equivalent with Board Certification in Oncology area preferred.
- 8+ years, Oncology/Hematology experience preferred, including experience with solid tumor studies, basket studies, and complex studies
- Previous CRO experience preferred.
- Expert level of knowledge in the main field of interest and/or assigned therapeutic area, together with a thorough working knowledge in pharmaceutical medicine or medical device fields, clinical development, GCP and regulations pertinent to clinical research.
- Fluency in English is essential and working of a second language is preferable.
Why choose Premier Research?
- Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability, or veteran status.
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