Medical Expert, Clinical Development*
- Cambridge (Boston)
- Work experience
- Research, development, teaching
Medical Expert, Clinical Development*
Based in Cambridge, MA, BioNTech US serves as BioNTech’s North American headquarters and is an important part of our global effort to pioneer the development of next-generation immuno-oncology therapies. BioNTech US is a fully integrated subsidiary with a strong foundation in Europe and a focus on the development of novel neoantigen-targeted T cell therapies, complementing BioNTech’s highly innovative scientific approach and diversified pipeline of transformative cancer medicines. As a key research and clinical development hub, BioNTech US will enable BioNTech’s growing presence in the US.
The Medical Expert, Clinical Development (MECD) is responsible for conduct of one or more assigned programs within the BioNTech oncology pipeline, including medical aspects of clinical study design, medical review of study data, and related data cleaning. The MECD will contribute to overall clinical study timelines and key deliverables. Additionally, the medical expert will have an important role as first Sponsor contact with study centers for a variety of site questions which may arise during the course of trial conduct. The MECD will also work closely along with BioNTech Medical Directors to execute the program development strategy.
Here, you’ll achieve greatness.
- Function as the key member of the clinical study team and lead the medical aspects of the study
- Develop, review and edit essential study documents such as protocols, medical monitoring plan, and medical data reviewing plan, case report forms, database specifications, statistical analysis plan, and clinical study reports including tables, listings and figures
- Provide medical input in all essential documents, including, investigator brochure, IND and NDA summary documents as well as safety annual reports
- Perform routine stringent medical data review, approve study enrollment, monitor the safety of the patients enrolled to the study, communicate with the investigators and site study teams on medically related issues
- Collaborate in safety monitoring of clinical trials, and provide support in preparation/review of SAE narratives or narratives for adverse events of special interest
- Ensure that Clinical Development Standard Operating Procedures (SOPs) facilitate the development of effective clinical study protocols and are compliant with clinical, medical, and industry standards as well as GCP
What you have to offer.
- MD, PhD or equivalent
- At least three years of experience with industry or academic clinical research or development in a medical expert/medical monitor or similar function
- Experience in oncology clinical trial design and execution, preferably phase I and first-in-human, including medical review
- Experience with regulatory submissions and health authorities
- Experience in clinical stage development, preferably with focus on phase I and first-in-human trials, with strong understanding of the medical oncology aspects of clinical trials
- Ability to effectively manage multiple priorities and deliverables according to approved timelines and budget
- Excellent research, analytical and problem solving skills as well as excellent verbal, written communication and presentation skills
- Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements
Benefits for you.
- Medical, Dental and Vision Insurance
- Life, AD&D, STD and LTD Insurance
- HSA & FSA Spending Accounts
- Health & Wellness, including free onsite gym access
- Adoption & Surrogacy Assistance
- Vacation and Unlimited Sick Time
- Holidays and Floating Holidays, including discretionary winter shutdown
- 401(K) Plan with Significant Company Match
- Tuition Reimbursement and Professional Development
- Commuting Assistance and free onsite parking
- Discounted Home and Auto Insurance
- Pet Insurance
Have we kindled your pioneering spirit?
For those who require assistance due to disability, or have questions prior to applying, please email email@example.com.
*BioNTech does not differentiate on the basis of gender, race, religion, color, origin, sexual orientation, disability, age and other protected status as required by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer.
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