Global Director of Clinical Operations (f/m/d) 100 %

Jobinhalt

General Description

Under the Direction of the Chief Medical Officer, the Director of Clinical Operations will be leading the execution of our current and future clinical trials assigned to the director, which includes the management of the clinical department in collaboration with the other management functions in the clinical department.

Key Responsibilities

As a key member of the company’s management team, lead the company’s Clinical Department in collaboration with other management positions in the clinical department and be responsible for the successful execution the company’s

clinical trials and clinical trial strategy assigned to the clinical director. Design and set-up new clinical studies and manage their timely execution, including the execution of ongoing studies, up to completion, including finalization of clinical study reports and publication. You will work with the Company’s established research partners and you will help establish new research partners.

Principal duties associated with these responsibilities are summarized as follows:

1. Provide leadership and management direction to the clinical and safety team members for the assigned

programs, this includes oversight for the following activities listed, but not limited to:

• International pharma and device study protocol development and implementation, CFR Design, project planning and report writing
• Lead / assistance with site selection and investigator recruitment
• Assisting sites with EC applications
• Site initiation and staff training (including CRO training)
• Monitoring of clinical data
• Study drug and device inventory and reporting
• Adverse event monitoring and reporting

2. Represent, together with other clinical management team members, the clinical team and ensure clinical requirements are aligned with other internal departments (such as, but not limited to R&D, Drug Procurement, Regulatory and Quality, Human Resources)

3. For the assigned projects ensures the clinical requirements for regulatory filings are met (Notified Bodies, including Post Market Clinical Follow up, FDA, EMA, and other where applicable)

4. Collaborate with in- and external partners (including investigators) to drive study results presentation and/or publication

5. Oversee and coordinate CMC / infusate supply activities in cooperation with other Clinical or Supply Chain team members

6. Set and maintain assigned clinical operations budget for assigned programs

7. Oversee- for assigned programs - clinical study execution to ensure studies are completed on time, within budget, and in compliance with Pharma and Device SOPs, ICH/GCP/GxP guidelines, and applicable regulations

8. Mentor and develop clinical team members to foster individual growth and promote internal talent

9. Develop training plans and programs to enhance clinical operations

10. Assist in resource planning and budgeting to meet deliverables and achieve company goals

11. Build effective working relationships with both internal and external partners

12. Set strategy direction for clinical outsourcing, oversight; provide leadership in CRO and vendor selection and management; establish and maintain strong relationships with CROs

13. Measure and evaluate performance and take appropriate action if applicable

14. Represent company at professional meetings, congresses and other industry events

15. Participate in the development and review of standard operating procedures

16. Understanding and application of various quality ´systems within the company and in compliance with international standards

17. Remains up to date with the relevant medical literature pertaining to the assigned therapeutic domain(s)

18. Travel as required including intercontinental travel

Key requirements

• Demonstrated capacity to lead a clinical team, including remote employ
• Ability to develop and maintain professional relationships with hospitals, doctors and clinical staff
• Strong interpersonal and communication skills, including the ability to present results at major scientific meetings
• Expert knowledge of how to conduct a GCP study and experience with regulatory requirement for Pharma and/or Medical Device clinical studies (including IND/IDE, PMA, CE-mark / MDR)
• Good organizational and project management skills and ability to handle multiple diverse projects
• simultaneously
• Experience developing and executing a scientific publication strategy, as well as organizing small scientific meetings (such as expert meetings or advisory boards)
• Ability to conduct interviews with physicians to gain feedback on products
• Expert proficiency in reading, writing and speaking English
• Ability and appetite to work in a fast paced start up environment
• Desire to help develop strategy marketing plans
• Interest in working with R&D to ensure that new products exceed customer expectations
• Position may require up to 50% travel
• Work 50% in Ghent office / 50% at home (Company Policy)

Required Education / Experience

• Post graduate Degree in Life Sciences or appropriate experience
• 7+ years of Pharma and/or Medical Device Clinical Trial Management (ideally experienced within Active Implantable Devices and/or Pharmaceutical Infusion Products in an international context)
• Good knowledge of CMC processes / pharmaceutical manufacturing is a plus
• Proficient in reading, writing and speaking English (multiple languages is a plus)
• Knowledge of and expertise in (ideally including a KOL network) the following therapeutic domains are considered a strong advantage: heart failure and/or chronic liver disease