Director* Clinical Operations (Oncology)
Open for hire at one of the following locations – Cambridge Erie Street, Gaithersburg, London, Mainz Goldgrube. - Job ID: 3500
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.
Director* Clinical Operations (Oncology)
Responsibilities
• Contribution to the development and review of portfolio documents such as Oversight Plans, Process Developments (including Trial RACI), and SOP development
• Supervision of the project team member’s adherence to the regulatory requirements, ICH-GCP guidelines, relevant procedures, and conduct of respective training
• Point of escalation in case of challenges in project activities with other sponsor departments or external vendors.
• Instruction and supervision of ADCT, CTMs, CTCs, CRAs, and CTAs (line Management)
• Resource planning of the team in alignment with the Senior Director, Clinical Operations.
• S/He is involved in the governance structure and oversight with CROs and vendors
• Overlooking the process of selection and decision on the participation of vendors for a clinical trial and providing the strategic sourcing approach to the individual study team.
• Contributing to the selection and decision process on the participation of vendors, preferred vendors, and partnership vendors.
• Oversight on project/program timelines and deliverables and identify future program needs.
• Oversight; if the project team has appropriate training and reports training needs to the Senior Director, Clinical Operations
• Organize and conduct team meetings
• Taking care of team developments, identification of high-performance team members, and working on team development together with the Senior Director, Clinical Operations
• Support the QA team during internal audits, vendor audits, and/or hosting inspections
• Adherence to the regulatory requirements, the ICH-GCP guidelines, and the respective procedures (i.e., policies, SOPs, instructions)
Qualifications
Education
• Natural/ life sciences or medical background (university degree or experience in a medical profession such as Nurse or Medical Technical Assistant or Pharmaceutical Technical Assistant)
Experience
• Profound knowledge and experience in relevant legislation and international guidelines (ICH-GCP) for the performance of clinical research projects
• Minimum 12+ years of experience in project management, regulatory submissions, and global study organizations
• Refined colloquial and correspondence skills (written and spoken)
• Experience in usual software (Word, Excel, PowerPoint, MS Project)
• Ready to take over responsibility
• Able to rapidly enter into action and to work under stressful conditions
• Able to motivate and lead a team/ used to working in a team environment
• Able to recognize problems and provide solutions
• Excellent organizational skills
• Excellent communicative skills
• Independent and proactive way of working
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, Gaithersburg, 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!