Associate Director, Clinical Trials

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
• PMP or equivalent certification desirable
• 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.

 

Your Benefits:

 

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
• Wellbeing Incentive Platforms & Incentives
• Professional Development Programs
• Commuting Allowance and subsidized parking
• Discounted Home, Auto & Pet Insurance

 

…and more! More details to be shared.
 

 

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,