BioNTech IMFS
Senior Director/Director Clinical Development
BioNTech IMFS, Cambridge, Massachusetts, us, 02140
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Senior Director/Director Clinical Development New Jersey, US; Cambridge, US; Gaithersburg, US; London, United Kingdom; Mainz, Germany | full time | Job ID:9682
The (Senior) Director, Clinical Development will collaborate closely with the VP of Clinical Development to lead clinical strategies for assigned programs. This role involves overseeing the design and execution of clinical trials from early to late stages, ensuring data integrity, patient safety, and regulatory approval. You will lead a matrix team and apply your deep understanding of scientific, medical, and disease biology to guide decisions.
Key Responsibilities
Oversee and steer clinical trial design and execution, developing clinical plans for new compounds and leading towards regulatory approval.
Collaborate with the VP to operationalize clinical strategies for assigned portfolios.
Lead program strategy, development plans, and submission processes.
Serve as Program Lead, guiding core teams and aligning objectives across functions.
Ensure medical and safety aspects of studies, including risk-benefit assessments and medical queries.
Work closely with Clinical Operations to ensure patient‑centric drug development.
Drive innovation in trial design, leveraging digital endpoints and real‑world evidence.
Prepare key clinical documents (e.g., Investigator’s Brochures, NDAs) and ensure high‑quality medical content in Clinical Study Reports.
Manage relationships with external stakeholders and represent the team in governance meetings.
What you have to offer
M.D. with strong scientific and clinical background in Immuno‑Oncology, Oncology
Several years of experience within Immuno‑Oncology, Oncology at the biotech/pharmaceutical and the academic setting, including leading clinical development programs from exploratory Phase I/II clinical studies through late stage development in Phase III and NDA submission.
Thorough understanding of the clinical and scientific methods and approaches used in clinical development studies, as well as novel clinical study designs, application of companion diagnostics for patient selection, clinical pharmacology/ translational modeling and biostatistics. Complemented with several years of experience on confirmatory PH3 trial design and respective dossier preparation and submission activities.
Experienced in global health authority interactions (EMA, FDA, MHRA, CDE). Having participated or led a drug development program to successful registration is an advantage.
Strong medical experience in overseeing and interpreting safety and efficacy clinical trial data and ensuring appropriate contact for study medical and patient safety aspects.
Ability to apply situational management style to both mentor and accelerate capabilities of its reports.
Expected Pay Range: $267,000/year to $397000/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). *Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.
BioNTech US is committed to employee wellbeing and offers best‑in‑class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position‑Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to:
Medical, Dental and Vision Insurance
Life, AD&D, Critical Illness Insurance
Pre‑tax HSA & FSA, DCRA Spending Accounts
Employee Assistance & Concierge Program (EAP) available 24/7
Parental and Childbirth Leave & Family Planning Assistance
Sitterstream: Virtual Tutoring & Childcare Membership
Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year‑End U.S. Shutdown.
401(K) Plan with Company Match
Tuition Reimbursement & Student Loan Assistance Programs
Professional Development Programs
Commuting Allowance and subsidized parking
Discounted Home, Auto & Pet Insurance
Apply now - We look forward to your application! Apply for our New Jersey, US; Cambridge, US; Gaithersburg, US; London, United Kingdom; Mainz, Germany location and simply send us your documents using our online form.
By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech‑Recruiter.
Inspired? Become part of #TeamBioNTech. BioNTech, the story
At BioNTech, we are more than just a biotechnology company – we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting‑edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases.
Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop business strategies driven by our shared passion for advancing medicine.
Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world.
BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer.
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Senior Director/Director Clinical Development New Jersey, US; Cambridge, US; Gaithersburg, US; London, United Kingdom; Mainz, Germany | full time | Job ID:9682
The (Senior) Director, Clinical Development will collaborate closely with the VP of Clinical Development to lead clinical strategies for assigned programs. This role involves overseeing the design and execution of clinical trials from early to late stages, ensuring data integrity, patient safety, and regulatory approval. You will lead a matrix team and apply your deep understanding of scientific, medical, and disease biology to guide decisions.
Key Responsibilities
Oversee and steer clinical trial design and execution, developing clinical plans for new compounds and leading towards regulatory approval.
Collaborate with the VP to operationalize clinical strategies for assigned portfolios.
Lead program strategy, development plans, and submission processes.
Serve as Program Lead, guiding core teams and aligning objectives across functions.
Ensure medical and safety aspects of studies, including risk-benefit assessments and medical queries.
Work closely with Clinical Operations to ensure patient‑centric drug development.
Drive innovation in trial design, leveraging digital endpoints and real‑world evidence.
Prepare key clinical documents (e.g., Investigator’s Brochures, NDAs) and ensure high‑quality medical content in Clinical Study Reports.
Manage relationships with external stakeholders and represent the team in governance meetings.
What you have to offer
M.D. with strong scientific and clinical background in Immuno‑Oncology, Oncology
Several years of experience within Immuno‑Oncology, Oncology at the biotech/pharmaceutical and the academic setting, including leading clinical development programs from exploratory Phase I/II clinical studies through late stage development in Phase III and NDA submission.
Thorough understanding of the clinical and scientific methods and approaches used in clinical development studies, as well as novel clinical study designs, application of companion diagnostics for patient selection, clinical pharmacology/ translational modeling and biostatistics. Complemented with several years of experience on confirmatory PH3 trial design and respective dossier preparation and submission activities.
Experienced in global health authority interactions (EMA, FDA, MHRA, CDE). Having participated or led a drug development program to successful registration is an advantage.
Strong medical experience in overseeing and interpreting safety and efficacy clinical trial data and ensuring appropriate contact for study medical and patient safety aspects.
Ability to apply situational management style to both mentor and accelerate capabilities of its reports.
Expected Pay Range: $267,000/year to $397000/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). *Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.
BioNTech US is committed to employee wellbeing and offers best‑in‑class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position‑Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to:
Medical, Dental and Vision Insurance
Life, AD&D, Critical Illness Insurance
Pre‑tax HSA & FSA, DCRA Spending Accounts
Employee Assistance & Concierge Program (EAP) available 24/7
Parental and Childbirth Leave & Family Planning Assistance
Sitterstream: Virtual Tutoring & Childcare Membership
Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year‑End U.S. Shutdown.
401(K) Plan with Company Match
Tuition Reimbursement & Student Loan Assistance Programs
Professional Development Programs
Commuting Allowance and subsidized parking
Discounted Home, Auto & Pet Insurance
Apply now - We look forward to your application! Apply for our New Jersey, US; Cambridge, US; Gaithersburg, US; London, United Kingdom; Mainz, Germany location and simply send us your documents using our online form.
By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech‑Recruiter.
Inspired? Become part of #TeamBioNTech. BioNTech, the story
At BioNTech, we are more than just a biotechnology company – we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting‑edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases.
Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop business strategies driven by our shared passion for advancing medicine.
Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world.
BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer.
#J-18808-Ljbffr