Jobs in the United States

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Added 1 min ago
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Sr CRA II
Actalent
Kansas City, MO
- $70 to $95 USD / hour
Job Title: Clinical Research Associate (CRA) Central or West RegionJob DescriptionThis role performs and coordinates all aspects of clinical monitoring and site management for sponsored…
Added 1 min ago
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Sr CRA I
Actalent
Kansas City, KS
- $58.62 to $62.07 USD / hour
…doorBenefits included (w2 only)Job Title: Senior Clinical Research Associate I (Sr CRA I)Job DescriptionThe Senior Clinical Research Associate I performs and coordinates all aspects of…
Added 4 mins ago
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Associate Director, Biomarker Program Management
AbbVie
Waltham, MA
- $141,500 to $268,500 USD / year
This role can be based in North Chicago, IL, Waltham, MA, or South San Francisco, CA
Added 4 mins ago
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Associate Director, Biomarker Program Management
AbbVie
San Francisco, CA
- $141,500 to $268,500 USD / year
This role can be based in North Chicago, IL, Waltham, MA, or South San Francisco, CA
Added 4 mins ago
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Associate Director, Biomarker Program Management
AbbVie
North Chicago, IL
- $141,500 to $268,500 USD / year
This role can be based in North Chicago, IL, Waltham, MA, or South San Francisco, CA
Added 4 mins ago
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Manager, Quality & Compliance
AbbVie
Mettawa, IL
- $109,500 to $208,500 USD / year
This role requires the candidate to be physically located in Lake County, Illinois and adhere to 3-day in office ways of working · The individual must possess sound judgment in evaluating and establishing compliance strategic plans as well as in day-to-day situations
Added 6 mins ago
Production Technician
Pioneer Hi-Bred International, Inc
Maxton, NC
At Vylor, we’re advancing agriculture through breakthrough science - combining elite germplasm, cutting-edge biotech, and next-generation expertise in gene editing and molecular breeding.…
Added 6 mins ago
Assistant/Associate Professor of Biostatistics and Data Science
Harvard University Faculty
MA
Candidates must have completed their doctoral degree prior to the start date of the position
Added 6 mins ago
Mechanical Technician
Corning
Wilmington, NC
Corning is one of the world’s leading innovators in glass, ceramic, and materials science. From the depths of the ocean to the farthest reaches of space, our technologies push the…
Added 10 mins ago
Network Engineer - Principal
Amentum
Warrenton, VA
Must have active Top-Secret clearance with SCI or the ability to acquire Top Secret/SCI
Added 11 mins ago
PRN Infusion Front Office Specialist
HCA Healthcare
Charleston, SC
PC skills – must have an understanding of MS word applications and demonstrates proficiency in PC applications as required for the position
Added 12 mins ago
Cardiovascular Technologist- Paramedic
Phoebe Putney Memorial Hospital, Inc.
United States
A 2-year minimum associate, or baccalaureate academic program in health science (includes, but not limited to, cardiovascular technology, radiologic technology, respiratory therapy,…
Added 13 mins ago
Post-Doctoral Associate
Rutgers University-New Brunswick
NJ
Rutgers, The State University of New Jersey, is seeking a Post-Doctoral Associate in the Center for Immunity and Inflammation within the New Jersey Medical School (NJMS).
Added 13 mins ago
Retail Customer Service Associate
FedEx Office
Philadelphia, PA
Ensures confidentiality of customer data and careful handling of documents, media, and packages
Added 15 mins ago
Computer Network Defense Analyst 4
RealmOne
Central Maryland, MD
18 semester hours of military training/coursework in networking, computer science, or cyber topics is equivalent to an Associate's degree.
Added 15 mins ago
Associate Director, Biotherapeutic Production and Characterization
Generate Biomedicines
Somerville, MA
The Associate Director will lead a talented scientific team working at the intersection of biological engineering, protein science, automation, and data-enabled discovery. You will help…
Added 16 mins ago
District Manager/Sales
Specialty Distribution Group LLC
Greenville, SC
We are seeking an ambitious, motivated Outside Sales Associate looking to help our fast-growing business grow even faster. If you are a top performer, want to manage your own territory, and…
Added 16 mins ago
TT
EMS Senior Technician
The Tsui Group
Los Angeles, CA
- $110,000 to $115,000 USD / year
Graduation from a recognized college or university with a bachelor’s or associate degree in engineering (mechanical, computer science, electrical, information technology)
Added 19 mins ago
HD
Data Analyst 2 - 89015
Health, Department of
Albany, NY
- $90,582 to $114,585 USD / year
Substitution: An associate’s degree may substitute for two years of general experience; or a bachelor’s degree may substitute for four years of general experience. A master’s degree in data…
Added 19 mins ago
MH
Administrative Assistant 1/Trainee (NY HELPS), Central Office;
Mental Health, Office of
Syracuse, NY
- $42,209 to $49,841 USD / year
Certification (e.g., IAAP Certified Administrative Professional) or associate’s degree in office administration, secretarial science, administrative assistance, paralegal, business…
Added 21 mins ago
Director / Associate Director, Clinical Science
BioNTech
Berkeley Heights, NJ · Gaithersburg, MD · Cambridge, MA
…standards. This includes monitoring study progress, reviewing study data, and ensuring that adverse events are reported and managed…
Added 22 mins ago
Manager, Software Engineering (PLS Billing & Digital Servicing Run)
Nationwide Life and Annuity Insurance Co
OH
Work Arrangement: This role follows a hybrid schedule and requires in-office presence in our Columbus OH office two days per week
Added 22 mins ago
Manager, Software Engineering Product Manager (Software Supply Chain Security)
Nationwide Life and Annuity Insurance Co
OH · AZ · IA
This role will work a hybrid schedule coming into the Columbus, Ohio (preferred), Des Moines, Iowa, or Scottsdale, Arizona office 2 days per week
Added 22 mins ago
Clinical Research Data Sr Associate
The Nebraska Medical Center
Omaha, NE
Responsible for the collection and review of clinical protocol research and registry data. Interpret data (including appropriate source documentation) for entry into computerized databases.…
Added 22 mins ago
Senior Clinical Research Associate
PSI CRO
Remote, United States
As a Senior Clinical Research Associate you will work on the frontline of communication with project stakeholders, ensuring timelines, targets and standards of clinical research projects in…

BioNTech

Director / Associate Director, Clinical Science

Berkeley Heights, NJ, United States
Gaithersburg, MD, United States
Cambridge, MA, United States

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Job details

Experience: 8+ years of industry experience
Posting language: English
Posted: Nov 3, 2026

Original job description

London, United Kingdom; Cambridge, US; Gaithersburg, US; New Jersey, US | full time | Job ID: 11593

Your Contribution:

Contribute to designing clinical trials to evaluate the safety and efficacy of investigational drugs. This includes developing the study protocol, identifying patient populations, selecting study endpoints, and determining theappropriate study design.
Responsible for clinical development oversight of clinical trials to ensure that they are conducted in accordancewith the protocol, regulatory requirements, and ethical standards. This includes monitoring study progress, reviewing study data, and ensuring that adverse events are reported and managed appropriately.
Contribute to and/or lead the creation of study-level documents, including protocol development, preparation ofclinical sections of key regulatory documents, such as Investigator’s Brochures, briefing books, safety updatesand submission dossiers. Contribute to the review and writing of clinical trial documents for CTR activities, and publications (if applicable).
Under guidance of Clinical Development Lead, address regulatory/health authority queries and ensurecompliance with guidelines.
Contribute to the development of the Clinical Development Plan, Integrated Evidence Plan and the clinical component of the TPP.
Collaborate with cross-functional teams, including, but not limited to, clinical operations, biostatistics, regulatory affairs, and medical affairs, to ensure the successful execution of clinical development programs.
Develop protocol and clinically relevant training materials, share best practices and provide training to the broader clinical trial teams, investigator sites, CRO partners, etc.
Collaborate with medical safety and pharmacovigilance on safety evaluations and signal detection.
Contribute to aggregate reports, patient narrative reviews, attendance of pharmacovigilance monitoring meetings)
Support regulatory activities, like preparation of meetings with regulatory agencies.
Support preparation and (if applicable) participate in study level meetings, for example Investigator Meetings, Data Monitoring meetings, and others.
Supports and guides the development of data review strategy, ensuring that protocol-level deviations, eligibility criteria, study assessments & other aspects of the protocol are implemented consistently across the study(across countries/ sites). This could also include support for Case Report Form (CRF) development, andimplementation of data capture tools.
Perform high quality clinical data review and identify clinical data insights through ongoing patient level reviewand trends analysis, thereby supporting for example Interim Analysis, Database and Post Lock activities andresolution of scientific & medical issues throughout the study lifecycle.
Work to improve the quality of reviews/ insights with an emphasis on subject safety and eligibility, data integrity,trend identification, analysis and remediation, and identification of cases for medical review.
Provide insights and facilitate data review process improvements, for example by identification of redundant reports, implementation of innovative data analysis processes and tools, and their continuous improvement.
Work effectively in a matrixed team within the clinical science organization. For Director level this includes providing guidance and mentorship to junior team members.

A Good Match:

College degree in life sciences/healthcare/nursing. Advanced degree preferred
8+ years of industry experience
Strong familiarization with Good Clinical Practice (GCP) and drug development processes, ideally Phase 1 – 3;ideally paired with experience in Oncology / Immuno-Oncology
Good knowledge of set-up, organization and execution of global clinical studies in a pharmaceutical companyor contract research organization (CRO), or comparable experience within academic research institutions.
Sound knowledge of principles of clinical data collection and reporting; demonstrated ability to use systems andtools (e.g., EDC systems, Excel, etc.) for data collection, analysis and reporting. Ideally first experiences in howto improve and accelerate processes, systems and tools and drive continuous improvement.
Experience to work in a matrix, ability to influence without authority
High flexibility and adaptive working style, ability to work on several tasks at the same time
Ability to work effectively under high time pressure, while maintaining high quality standards
Ability to effectively prioritize tasks, and implement accordingly
High proficiency in English (written and spoken)

Your benefits:

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.

Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

How to apply:

Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.

Please note:

Only applications sent via our online form shall be considered. 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.

We are looking forward receiving your application.

Apply on jobs.biontech.com About employer

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Jobs in the United States