Clinical Operations Lead

The organization

For a brand new biotech, which is currently rapidly developing a highly potent COVID19 drug, we are looking for a Clinical Operations Lead. Making use of the cutting-edge research of VIB scientists, they have developed a camelid antibody that shows great promise to successfully treat patients infected with the new corona virus. In the light of the current health crisis, they have raised 23 million euros and gained the support of a big biopharmaceutical player to fast-track their compound to the clinics and the patient.

The position

Planning to start their clinical trials by January, they are looking to hire an experienced clinical specialist to ensure a smooth, successful and fast progression of the multiple clinical trials. A really challenging high-impact role where you will directly contribute to successful development of a drug that will combat COVID19!

Tasks & responsibilities

As Clinical Operations Lead you will, in direct collaboration with the Chief Medical Officer, drive the clinical research by managing the sponsored clinical trials. In particular you will be in charge of the daily operational aspects of these trials. Responsibilities include: CRO/vendor management of all CRO’s/vendors involved in clinical trial and coordination of activities, planning resources, clinical trial budget/invoice review and management. Therefore ensuring that clinical trial timelines and deliverables (submission, recruitment, CSR etc) are properly coordinated and achieved.

Your day-to-day will consist of, among others, the following tasks and responsibilities:

• Functioning as the internal and external point of contact for all clinical operations matters
• Clinical supply management
• Providing operational input to and review of clinical study protocols, ICF, eCRF and other study related documents
• Clinical operations review and/or approval of study plans (including Monitoring Plan, Project plan, Data Management Plan, Safety Plan, SAP, Mock TLFs, DTA)
• Contract management for contracts related to clinical trials: vendors, partners, academic collaborations
• Ensuring compliance with the clinical trial registry requirements
• Providing input into baseline budget and timeline development and managing the studies against planned budget, timelines and results
• Leading risk assessment and identifying risk mitigation strategies at the study level
• Managing feasibility assessment to select relevant regions and countries for the study
• If and when applicable, raising issues related to study conduct, quality, timelines or budget to CMO and developing and implementing appropriate actions to address these issues

Candidate profile

As this ideal candidate for the position of Clinical Operations Lead you will recognise yourself in the following:

• You are PhD or MSc with a (bio)medical, pharmaceutical, biochemical or biotechnological background
• With at least 10 years of clinical operations and project management experience
• This experience you have gained in a biotech or pharmaceutical company, preferably at senior management level
• By showing great skill in managing and coordinating CROs/vendors
• You work structured and highly organised with a pro-active, hands-on attitude
• By implementing your thorough understanding and experience with implementation of GCP
• You like working in a semi-virtual environments
• By displaying excellent communication skills in English (oral and written)
• You are based in Belgium

The offer

There is absolutely no time to waste. Developments within the organisation have primed them to be at the gate of the clinic, the only person they need now is you to drive this program further!
You will get all communication and transportation means available to execute your mission and will be rewarded with a competitive salary plus rewards package.

Interested?

You can apply to this position by using the link below. For more information please feel free to contact Martin van der Velden, Principal Associate | Biotech/Pharma division, +31(0)6-83656209, +31(0)23-7548660.