Associate Director Clinical Operations

A global pharmaceutical company is looking to hire an Associate Director of Clinical Operations. You will report to the Director of Clinical Operations, and help manage a small team. Working on global studies across phases II-III, your role will be a combination of oversight and hands-on delivery.

Applicants must have a strong global clinical trial management and vendor oversight background and must have comprehensive sponsor/pharma experience. My client is prepared to consider a candidate at the Senior CTM/PM level with strong oversight experience who is looking to move into a more senior role, or someone currently at AD/Senior Manager level seeking broader scope.

Role Responsibilities:

• Oversees the clinical feasibility assessment and strategic planning of clinical trial programs or studies.
• Executes on these global programs or studies in one or more assigned therapeutic area(s) from decision to start a clinical development up to the market authorisation.
• Manage budgets, timelines and quality of deliverables for assigned programs and studies.
• Oversee integrity of clinical data to ensure data meets GCP standards.
• Participate in cross functional project teams and presents program information to internal and external audiences.
• Provide clinical review/input to Investigator Sponsored Research proposals.
• Assess best strategic path forward for a clinical program and drive clinical strategy recommendations including timelines and cost to key stakeholders.
• Draft clinical components from decision to start a clinical development and up to market authorisation
• Liaise cross-functionally to provide clinical input on all development stages and Target Product Profile.
• Provide clinical status updates to the Project Management Office and to upper Management.
• Manage direct reports through performance evaluations and addressing professional development.
• Ensure compliance of each Clinical Development trial team with the trial-specific training requirements
• Participate and contribute to internal and external training for clinical program (e.g. Kick-off meeting, Investigator's meeting)
• Participate in development of vendor specifications to ensure accurate interpretation of the protocol requirements.
• Support the Program Manager in overseeing third party vendors performance (e.g., contract research organizations (CROs), central labs) including on time study completion, budget adherence, and quality deliverables.
• Contribute to the evaluation of the vendor performance to ensure early mitigation/resolution of potential issues and develops/implements corrective action plans as appropriate, along with the Program Manager.
• Perform Sponsor Site Visits at selected sites to oversee the site and the monitoring performances
• Provide clinical review/input to clinical documents (e.g., protocols, investigator brochures, periodic safety reports and clinical study reports) and ensures the accuracy and integrity of clinical data prior to submission to regulatory authorities.
• Draft or provide review/input for publications from clinical study data and white paper literature reviews on new products or safety questions.
• Participates in regulatory authority meetings.

Person Specification

• A minimum Bachelor's degree in relevant discipline.
• 10+ years of clinical research experience with at least 6 years clinical trials management / leadership role, including clinical document production, trial execution and involvement in clinical trial feasibility and strategy.
• Advanced leadership and clinical trial/project management experience in managing study teams, vendors, and other cross-functional personnel.
• Advanced strategic thinking abilities for proactive planning and decisive decision making.
• Strong ability to set and meet deadlines, multitask, and prioritise based on program and/or study needs.
• Advanced ability to facilitate and/or present at departmental, study, project and investigator meetings.

For additional information and a confidential discussion, please apply now with an updated CV.