Associate Director, Clinical Trials

BioNTech•Cambridge, MA

About The Position

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.

Requirements

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

Nice To Haves

PMP or equivalent certification desirable

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

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