BioNTech IMFS
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New Jersey, US; Cambridge, US; Gaithersburg, US | full time | Job ID:9982
As Associate Director Clinical Trials you are responsible for the execution of clinical trials, mainly with regard to operational and administrative aspects. This implies the preparation and processing of national and international projects under consideration of the local laws, international guidelines (ICH GCP) and applicable SOPs. You perform activities related with the heading of a project team, the supervision/ control of third‑party providers, the timely performance of all services, as well as the problem management by interacting with all departments involved.
Responsibilities
Leads 1 or more complex/large scale clinical trial/s in either early or late stage clinical development within a program (+8 years of experience)
Leading communications, issue escalations and helping the teams within the program to further develop
May have more junior trial managers reporting. Global study management experience needed
Manages the Clinical Research Organization (CRO) and vendor(s) as it relates to clinical program level deliverables
Manages clinical study timelines for the program(s)
Ensures inspection readiness throughout the clinical program lifecycle
May be responsible for line management of one or more direct report
Qualifications
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
Minimum 8 years of experience in pharmaceutical/biotech or related industry with at least 4 years’ experience in Global Clinical Development working on cross‑functional teams
Knowledge and experience working with legislation and international guidelines (ICH‑GCP/CFR) for the performance of clinical research projects
Demonstrated experience with addressing regulatory inspections or internal process audits and drafting/reviewing responses to Health Authority and Ethics committee questions
Good communication and presentation skills both written and spoken inclusive of confident, articulate, and professional speaking abilities (with some experience)
Able to communicate strategy and decisions across different functions
Expected Pay Range Director: $146,300/year to $221,100/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
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, USlocation 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.
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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New Jersey, US; Cambridge, US; Gaithersburg, US | full time | Job ID:9982
As Associate Director Clinical Trials you are responsible for the execution of clinical trials, mainly with regard to operational and administrative aspects. This implies the preparation and processing of national and international projects under consideration of the local laws, international guidelines (ICH GCP) and applicable SOPs. You perform activities related with the heading of a project team, the supervision/ control of third‑party providers, the timely performance of all services, as well as the problem management by interacting with all departments involved.
Responsibilities
Leads 1 or more complex/large scale clinical trial/s in either early or late stage clinical development within a program (+8 years of experience)
Leading communications, issue escalations and helping the teams within the program to further develop
May have more junior trial managers reporting. Global study management experience needed
Manages the Clinical Research Organization (CRO) and vendor(s) as it relates to clinical program level deliverables
Manages clinical study timelines for the program(s)
Ensures inspection readiness throughout the clinical program lifecycle
May be responsible for line management of one or more direct report
Qualifications
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
Minimum 8 years of experience in pharmaceutical/biotech or related industry with at least 4 years’ experience in Global Clinical Development working on cross‑functional teams
Knowledge and experience working with legislation and international guidelines (ICH‑GCP/CFR) for the performance of clinical research projects
Demonstrated experience with addressing regulatory inspections or internal process audits and drafting/reviewing responses to Health Authority and Ethics committee questions
Good communication and presentation skills both written and spoken inclusive of confident, articulate, and professional speaking abilities (with some experience)
Able to communicate strategy and decisions across different functions
Expected Pay Range Director: $146,300/year to $221,100/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
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, USlocation 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.
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