BioNTech
Locations: Cambridge, US; Gaithersburg, US; New Jersey, US — Full time. Job ID: 9974
Responsibilities
Lead one or more complex/large scale clinical trial/s in either early or late stage clinical development within a program
Lead communications, issue escalations and helping the teams within the program to further develop
Manage the Clinical Research Organization (CRO) and vendor(s) as it relates to clinical program level deliverables
Manage clinical study timelines for the program(s)
Ensure inspection readiness throughout the clinical program lifecycle
May be responsible for line management of one or more direct report
Qualifications
Minimum 8 years of experience in pharmaceutical/biotech or related industry with at least 6 years experience in Global Clinical Development leading cross‑functional teams
A Bachelor’s degree in the life sciences or a university degree in a related field with experience in the health industry. Advanced degree preferred
Preferred experience with personalized mRNA vaccines in oncology clinical studies
PMP or equivalent certification desirable
Knowledge and experience working with legislation and international guidelines (ICH‑GCP/CFR) for the performance of clinical research projects
Involved with addressing regulatory inspections or internal process audits
Involved in drafting/reviewing responses to Health Authority and Ethics committee questions
Good listening and communication/presentation skills both written and spoken inclusive of confident, articulate, and professional speaking abilities
Able to communicate strategy and decisions across different functions
Standard use of Project Management skills including teamwork, analytical and problem‑solving, time management and organizational skills, risk and cost management, and performance monitoring
Skilled in using Microsoft Office programs (Word, Excel, Power Point, MS Project) as well as good working knowledge of electronic data systems and technical solutions such as eTMF, IWRS, EDC, etc. and developing presentation material
Resourceful and demonstrates high level of problem solving skills. Able to proactively recognize risks and develop mitigations
Builds a well performing team through developing honest relationships, and generating trust by demonstrating consistency between words and actions. Promotes an open team enviroment by allowing differing points of view to be expressed
Proactive in assuming responsibilities even when dealing with ambiguity in a rapidly changing enviroment
Expected Pay Range $171,000/year to $209,000/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.
Benefits
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
Wellbeing Incentive Platforms & Incentives
Professional Development Programs
Commuting Allowance and subsidized parking
Discounted Home, Auto & Pet Insurance
…and more! More details to be shared.
About the City Home to dozens of research institutions, biopharmaceutical companies, life science incubators, venture capital firms, and over 30 million square feet of laboratory space, Cambridge, Massachusetts has earned a reputation as the #1 life science cluster in the world. As part of the Greater Boston area, the city is often referred to as the “biotech supercluster” due to its high concentration of life sciences firms. This unique ecosystem is the result of a model partnership between academia and industry, fostering collaboration and innovation and driving the development of new therapies, medical devices, and diagnostics. As Cambridge’s thriving life sciences industry continues to evolve, the city remains a beacon of knowledge, innovation, and collaboration, poised to shape the future of science and technology.
Application Instructions Apply now – We look forward to your application! Apply for our Cambridge, US; Gaithersburg, US; New Jersey, US 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.
EEO Statement 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 personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you! BioNTech – As unique as you
#J-18808-Ljbffr
Responsibilities
Lead one or more complex/large scale clinical trial/s in either early or late stage clinical development within a program
Lead communications, issue escalations and helping the teams within the program to further develop
Manage the Clinical Research Organization (CRO) and vendor(s) as it relates to clinical program level deliverables
Manage clinical study timelines for the program(s)
Ensure inspection readiness throughout the clinical program lifecycle
May be responsible for line management of one or more direct report
Qualifications
Minimum 8 years of experience in pharmaceutical/biotech or related industry with at least 6 years experience in Global Clinical Development leading cross‑functional teams
A Bachelor’s degree in the life sciences or a university degree in a related field with experience in the health industry. Advanced degree preferred
Preferred experience with personalized mRNA vaccines in oncology clinical studies
PMP or equivalent certification desirable
Knowledge and experience working with legislation and international guidelines (ICH‑GCP/CFR) for the performance of clinical research projects
Involved with addressing regulatory inspections or internal process audits
Involved in drafting/reviewing responses to Health Authority and Ethics committee questions
Good listening and communication/presentation skills both written and spoken inclusive of confident, articulate, and professional speaking abilities
Able to communicate strategy and decisions across different functions
Standard use of Project Management skills including teamwork, analytical and problem‑solving, time management and organizational skills, risk and cost management, and performance monitoring
Skilled in using Microsoft Office programs (Word, Excel, Power Point, MS Project) as well as good working knowledge of electronic data systems and technical solutions such as eTMF, IWRS, EDC, etc. and developing presentation material
Resourceful and demonstrates high level of problem solving skills. Able to proactively recognize risks and develop mitigations
Builds a well performing team through developing honest relationships, and generating trust by demonstrating consistency between words and actions. Promotes an open team enviroment by allowing differing points of view to be expressed
Proactive in assuming responsibilities even when dealing with ambiguity in a rapidly changing enviroment
Expected Pay Range $171,000/year to $209,000/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.
Benefits
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
Wellbeing Incentive Platforms & Incentives
Professional Development Programs
Commuting Allowance and subsidized parking
Discounted Home, Auto & Pet Insurance
…and more! More details to be shared.
About the City Home to dozens of research institutions, biopharmaceutical companies, life science incubators, venture capital firms, and over 30 million square feet of laboratory space, Cambridge, Massachusetts has earned a reputation as the #1 life science cluster in the world. As part of the Greater Boston area, the city is often referred to as the “biotech supercluster” due to its high concentration of life sciences firms. This unique ecosystem is the result of a model partnership between academia and industry, fostering collaboration and innovation and driving the development of new therapies, medical devices, and diagnostics. As Cambridge’s thriving life sciences industry continues to evolve, the city remains a beacon of knowledge, innovation, and collaboration, poised to shape the future of science and technology.
Application Instructions Apply now – We look forward to your application! Apply for our Cambridge, US; Gaithersburg, US; New Jersey, US 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.
EEO Statement 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 personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you! BioNTech – As unique as you
#J-18808-Ljbffr