Associate Director, Clinical Trials

at  BioNTech AG

Open for hire at one of the following locations – London, Cambridge Erie Street, Mainz Goldgrube. - Job ID: 6720 - Hiring Manager: Juanita Brown

EDUCATION

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.

EXPERIENCE:

• PMP or equivalent certification desirable.
• Knowledge and experience working with legislation and international guidelines (ICH-GCP/CFR) for the performance of clinical research projects. Has been involved with addressing regulatory inspections or internal process audits. Involved in drafting/reviewing responses to Health Authority and Ethics committee questions
• Minimum 10 years of experience in pharmaceutical/biotech or related industry with at least 6 years experience in Global Clinical Development leading cross-functional teams.
• 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.
• Good listening skills.
• 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.
• Leadership: builds a well performing team through developing honest relationships, and generating trust by demonstrating consistency between words and actions. Promotes an open team environment by allowing differing points of view to be expressed. Proactive in assuming responsibilities even when dealing with ambiguity in a rapidly changing environment.

• Leads 1 or more complex/large scale clinical trial/s in either early or late stage clinical development within a program (+10 years of experience).
• Oncology experience required, registrational trial experience preferred.
• 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