Associate Director* Clinical Trial Management Individualized mRNA Cancer Vaccines
Open for hire at one of the following locations – Cambridge Erie Street, London, Mainz Goldgrube. - Job ID: 6728
Become a member of the BioNTech Family!
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 Trial Management Individualized mRNA Cancer Vaccines
Your main responsibilities are:
- 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
What you have to offer:
- 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
- Preferred experience with personalized mRNA vaccines in oncology clinical studies
- PMP or equivalent certification desirable
- 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
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.
Click here to find out more about what we do, the careers we offer and also the benefits we provide.
Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.
Have we kindled your pioneering spirit?
This vacancy is to be hired at one of the following locations – Cambridge Erie Street, London, Mainz Goldgrube. Apply now for your preferred job and location through our careers site.
*BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!