Director Clinical Operations (Oncology) - Home Based

Highly Competitive
  1. Permanent
  2. VP/Head of Clinical Operations
  3. Germany
Mainz (55131), Germany
Posting date: 16 Oct 2023

This vacancy has now expired. Please see similar roles below...

Proclinical Staffing are representing a trail blazing Biotech in Germany who are looking for a Director, Clinical Operations (oncology) to join their team in home-based position. Being a medium sized company with over 3000 employees globally, our client is looking for an established Clinical Operations professional who has a proven track record within the oncology field who can lead operationally, ideally with a Pharma/ Biotech background. Therefore, this opportunity will suit a professional who thrives in high performing environment which will elevate you in your career.

From day one, you'll manage a group of Clinical Study Manager level candidates globally so having prior experience with managing Study Managers (ideally on a global level) will be essential for this position. As part of the Global Clinical Operations department, you will be responsible for leading the studies for yourself, including planning of required resources as well as relevant vendors and systems. Thus, you will be a part of leading the Portfolio team and be the point of escalation for clinical trial activities. You are accountable for the continuous adaptation of internal departmental processes to the rapidly growing organisations within the company.

Your Main Responsibilities Are

  • Oversee activities related to the heading of the project teams, the supervision/ control of third party providers, the timely performance of all services, as well as stakeholder management of all departments involved.
  • Oversee the development and review of portfolio documents such like Oversight Plans, Process Developments (including Trial RACI) and SOP development.
  • Point of escalation in case of challenges in platform or vendor-related activities with other departments or external vendors; contributing to the process of selection and decision on participation of vendors, preferred vendors and partnership vendors.
  • Taking care of team developments, identification of high-performance team members and working on team development.
  • (Assurance of) Adherence to the regulatory requirements, the ICH-GCP guidelines and the respective procedures (i.e. policies, SOPs, instructions).

What You Have To Offer

  • 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), combined with many years of experience in project management, regulatory submissions and global study organisations.
  • Oncology or Infectious Diseases experience is preferred.
  • Profound knowledge and experience in relevant legislation and international guidelines (ICH-GCP) for the performance of clinical research projects.
  • Profound experience with the preparation and processing of national and international projects under consideration of the local laws, international guidelines (ICH GCP) and applicable SOPs.
  • Excellent communication and ability to recognise problems and provide solutions.
  • Able to rapidly enter in action and to work under stressful conditions.
  • Able to motivate and lead a team.

What's on offer? A competitive basic salary + 20% bonus + much more.

If you are having difficulty in applying or if you have any questions, please contact Jack O'Neill at +44 203 8460 646.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.