Vp, Clinical Operations Europe

Head of clinical operations Europe

Job profile

The Company

Evotec has evolved into one of the global leaders in providing complete drug discovery and development solutions on a stand-alone basis or through holistic, fully integrated R&D solutions. These services are provided on a typical fee-for-service basis or through a variety of commercial structures including research fees, milestones and/or royalties. The Drug Development Business Unit provides API and Drug Product Development and Manufacturing, Preclinical and IND enabling GLP/GMP programs up to Phase I and Phase II/POC including Regulatory Affairs, Clinical Development and Translational Medicine. European clinical operations operate from Italy, France and Germany. About 1000 employees constitute Drug Development in Evotec with one site in UK (Oxford), two italian sites (Verona and Modena) and one site in Germany (Halle, Westfallen).

The Role

The role of Head of Clinical Operations (ClinOps) is a key role within the Clinical Development & Translational Medicine Unit. The primary objective of the role is to bring the current European clinical operation team to the next level in terms of scale, capabilities and performance.

Specifically, the role is dedicated to achieving and exceeding business objectives through efficient execution, high quality and timely deliverables of all associated aspects of the clinical trial, in compliance with regulatory requirements and Good Clinical Practice guidelines. She/He is involved in the operational conduct of the study and acts with a critical thinking and problem-solving mindset.

She/He coordinates a team of clinical staff working in support of clinical studies to ensure projects are appropriately resourced and employees are trained and meeting project objectives.

The Head of EU Clinical Operations may also be part of a project team and be responsible for successful delivery of her/his own project deliverables, on time with high quality. The leader is responsible to provide clinical operation consultation to project teams as needed.

**Responsibilities**:

- Responsible for all operational aspects of clinical trial oversight including the delivery of every study on time within budget and scope in compliance with GCP’s, SOPs and standards
- Provide strategic input in the clinical operation process definition of client’s or internal clinical trials
- Day to day management and leadership of a team of Clinical Operations members by managing and overseeing team activities including appropriate resourcing of staff, staff assignments, quality control and efficiency of project deliverables
- Provide technical support to staff to ensure that they have the required knowledge to fulfil their duties. Ensure their performance meets and or exceeds both the business and their own personal goals/objectives through training, mentoring and allocating staff according to their ability
- May be responsible for own assignments as study/project team member. This may include but not limited to taking the role of a senior level contributor on a project team and ensuring high quality and timely delivery of own deliverables, generating study specific status reports for study teams, Sponsors and/or management, and attend project team meetings as required at the project level
- Collaborate with cross-functional teams to manage project related challenges and to achieve exemplary customer service
- Participates in corporate or organizational departmental quality or process improvement initiatives
- Work in partnership with the Project Manager to prepare, organize, and present at client meetings, including bid defence and kick off meetings
- Work in partnership with the Project Manager to ensure a seamless preparation of study related agreements, facilitate the relationship between clinical sites and vendors, and identification of project risks and contingency planning
- Work independently, managing interactions with and between clinical monitors, biostatistics, medical writing, safety and other key stakeholders

QUALIFICATIONS and SKILLS
- University degree (or higher, i.e. PhD) in scientific or healthcare disciplines
- At least 7 years of experience in clinical trials operations, with a strong knowledge of early clinical development
- Experience with the organization and management of Multi-Centric trials is a plus
- Proven direct experience in planning and managing all phases of clinical trials is required
- Demonstrated experience in Contract Research Organizations or exposure to CROs is required.
- In-depth knowledge of applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
- Good leadership skills with a can-do attitude
- Strategic thinking, problem solving attitude, good technical background, integrity, and project management skills
- Self-motivated with a high degree of initiative and sense of urgency
- Ability to work cross-fun