Associate Director, Clinical Trials

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

 

Join our team of pioneers!

As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.
 
We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.

 

Associate Director, Clinical Trials 

 

Responsibilities:

• 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

 

Qualifications:

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.

 

Benefits for you

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.