Job Description
A leading company in the biotechnology industry is currently seeking a Senior Director of Clinical Operations to join their team. The role will be challenging but also highly rewarding and this leader will be a key voice in the company. For the right executive, this is a fantastic opportunity with great growth prospects. Key duties include:
1) Provide a leadership role in managing multiple clinical research trials across all functional areas involved in the drug development process
2) Oversee and coordinate all operational aspects of clinical trials to ensure corporate goals of time, cost and quality performance expectations are met
3) Develop clinical research protocols and other clinical trial-related documents
4) Select clinical trials sites, proactively trains and supports site staff
5) Coordinate and facilitate regulatory submissions in support of clinical trial conduct
6) Identify risks and mitigate, resolve and escalate, as needed to address operational, compliance and other problems impacting trial progress and quality
7) Function as lead advisor for site audits, including defining, scheduling, assessing, evaluating and resolving eventual outcomes
8) Ensure monitoring reports are critically reviewed and appropriate follow-up is performed through resolution
9) Plan and conduct site visits to help establish, assist and evaluate operational execution of the study
10) Identify requirements and develop bids for clinical research activity providers, such as CROs
11) Develop clinical study budgets, participate in ongoing financial forecasting and perform reconciliation of invoices against planned spend
12) Coordinate on-schedule delivery of clinical trial supplies in collaboration with CMC function
13) Interview, hire and train Clinical Operations staff assigned to projects, as required
14) Mentor clinical operations staff and make recommendations for staffing needs
15) Author and maintain SOPs and CAPAs, as applicable
Critical Requirements
1) A university degree is required. Although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Recent experience in the biotechnology industry is strongly preferred
4) Preference will be given to candidates with recent experience in clinical operations management
If you are qualified and looking to work with a well-established company – one of the top names in the industry – you should not let this opportunity pass by. However, for this Senior Director of Clinical Operations role, you must be someone who is experienced and passionate about clinical operations management.
Compensation and Other Details
Base Salary: Highly competitive package, commensurate with experience