Associate Medical Director, Clinical Development*
- Cambridge, Massachusetts
- Work experience
- Research, development, teaching
Associate Medical Director, 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 Associate Director Clinical Development will work hand-in-hand with the VP of Clinical Development to implement clinical strategies and operationalize in assigned clinical trials. He/ She will work on the design and execution of clinical trials from early to late stage development through regulatory approval, collaborating within a matrix team. This includes thorough data interpretation based on deep scientific and disease biology understanding, translational expertise and medical knowledge, including patient safety and data integrity.
- He/ She will be hands-on involved in design and execution of clinical trials of his/ her assigned programs, supporting the creation of the clinical development plan for new compounds and/ or indications.
- The Associate Director Clinical Development will work closely with VP Clinical Development, and represent BioNTech in collaboration projects with industry partners, as appropriate. He/ she also contributes to interactions with academic study investigators, advisory meetings with opinion leaders, and interactions with Health Authorities. He/ she will support the VP Clinical in the development of presentations to senior management and decision makers.
- A genuine interest and understanding of the science supporting the pipeline, an ability to lead and work collaboratively in a multidisciplinary team setting, and a commitment to develop new treatments to address unmet needs in Oncology, Immuno-Oncology and Infectious Diseases are critical for success.
- Works hand-in-hand with the VP of Clinical Development to support development of clinical strategies, plans and their operationalization especially on trial level.
- Drives the operational planning, content, execution and delivery for our programs and studies. Will manage day-to-day clinical activities for our clinical studies including management of protocol amendments, overseeing data review activities and communicating with investigator / sites where appropriate.
- Assumes Program Lead responsibilities if assigned as clinical lead for a program; working hand-in-hand with VP Clinical Development to develop and implement CDP. Supports translation of Target Product Profile into clinical strategy.
- Collaborates with other development functions (e.g. Regulatory, Pharmacovigilance, Statistics, etc.) to support clarity on clinical objectives, and drives alignment on objectives and expected outcomes especially on a protocol and clinical study level.
- Contributes to the trial medical/ safety aspects and risk-benefit assessments supported by the Clinical Trial Scientists and Pharmacovigilance. Collaborates closely with Pharmacovigilance on development of Risk Management Plans.
- Collaborates and gives guidance for the Clinical Trial Scientists, and works with them on day-to-day basis on clinical trials, driving overall progress of study implementation
- Supervises and gets involved in ongoing medical data review, ensures medical queries of running studies are resolved
- Ensures on program (where appropriate) and trial level, that the clinical development team works hand-in-hand with Clinical Operations team for patient centric drug development, ensuring balancing of high medical quality, trial complexity, as well as time and cost considerations
- Collaborates with other partner functions in Development on the acceleration of program and trial design and innovation for the patient (e.g. digital endpoints, synthetic control arms, RWE/ HEOR, PRO, Medical Affairs)
- Creates input for clinical sections of key documents, including Investigator's Brochures, IND summary documents, CTAs, responses to questions from regulatory authorities, IRBs and ethics committees, and NDAs.
- Writes/ co-writes Clinical Study Report (CSR) medical content and ensures it meets high quality expectations on medical standards.
- Manages relationships with key external stakeholders (industry partners, Key Opinion Leaders, health authorities), where appropriate.
- Represents the team to decision/ governance meetings, senior management, or advisory boards as applicable.
- Contributes to a collaborate culture within and outside Clinical Development and actively manages best practice sharing and capability building within the clinical team.
What you have to offer.
- M.D. with scientific and clinical background in Immuno-Oncology, Oncology or Infectious diseases
- Minimum of 3 years+ of experience within Immuno-Oncology, Oncology or Infectious diseases at the biotech/pharmaceutical and/or the academic setting, including management of clinical development activities.
- Good understanding of the clinical and scientific methods and approaches used in clinical development, from FIH to registration; experience with regulatory processes and registration a plus.
- Experience in contributing to trial designs and protocols.
- Hand-on experience in managing the clinical day-to-day work for the successful delivery of clinical trials.
- Experiences in preparing global health authority interactions (e.g. EMA, FDA).
- Experience in overseeing and interpreting safety and efficacy clinical trial data and ensuring appropriate contact for study medical and patient safety aspects.
- Ability to plan clinical activities based on a TPP and CDP guidance, and translating them into trial designs
- Experiences with working in a matrix environment (global and cross-functional)
- Experience in collaborating and communicating with external collaboration partners like KOLs and investigators.
- Good understanding of the science supporting the clinical development programs. Confident to discuss and present scientific and mechanistic aspects of drug development.
- Subject matter expertise on drug development topics, and genuine interest to drive innovation and continuous improvement
- Proficiency in English (written and spoken)
Benefits for you.
- Medical, Dental and Vision Insurance
- Life, AD&D, STD and LTD Insurance
- HRA & 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
- Plus more benefits that will be shared upon hire!
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 or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!
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