Associate Director, Clinical Trial Management

BioNTech SE•Cambridge, MA

50d

About The Position

At BioNTech, we are more than just a biotechnology company - we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases. Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourageâ¯creativity, and develop business strategies driven by our shared passion for advancing medicine. Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world. 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. The main thing is that you suit us, and we suit you! BioNTech - As unique as you

Requirements

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
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

Nice To Haves

Preferred experience with personalized mRNA vaccines in oncology clinical studies
PMP or equivalent certification desirable

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

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