Vice President Clinical Operations
Reporting to the Chief Medical Officer, the VP of Clinical Operations will be accountable for the resourcing, development, training and management of the company’s clinical operations team. This role will also require hands-on participation on day-to-day activities on ongoing, planned clinical trials operation aspect, with extensive experience with interacting various types of CRO’s. The ideal candidate will have strong clinical, leadership and communication skills. In addition, the VP will be a hands-on leader willing to roll-up their sleeves to ensure the highest quality of work output. Experience in the Oncology pharma/biotech setting is required
- Provide direct oversight and management of operations and personnel involved in clinical operations, data management, medical writing and other functional groups or external vendors as assigned.
- Ensure that clinical trials are properly resourced, managed and executed in accordance with timelines and good quality practices.
- Provide operational and clinical expertise and strategic insights to develop a life-cycle strategy and evaluation of new programs to be prioritized or advanced into clinical development.
- Participate in the review, planning, and implementation of clinical trials, including evaluating hypothesis, objectives, study design, feasibility, regulatory requirements, and identifying medical and logistical problems that may impede the study.
- Develop clinical timelines, performance indicators and budget forecasts and be accountable for tracking and delivering accordingly.
- Represent all aspects of Clinical Operations and provide updates as required to the Executive Team, Study Team, and other key internal stakeholders.
- Ensure the effective and constructive integration of clinical operations knowledge and expertise into all applicable Clinical Development activities including integrated development plans and study protocols; interact and collaborate with other department heads as appropriate.
- Provide support for regulatory submissions, supporting dossier development and participatingin interactions with FDA and other regulatory agencies.
- Keep abreast of competitive regulatory and clinical practices and utilize this knowledge during
- the ongoing development and adjustment of plans.
- Review master service agreements, statements of work, and quality agreements relating to clinical operations.
- Implement best practices and standards for trial management in collaboration with other members of the clinical operations team, including establishment of SOPs.
- Lead initiatives to build clinical department infrastructure.
- Ensure that clinical trials are conducted in compliance with applicable regulatory requirements and are inspection ready.
- Support and mentor the Clinical Operations team, including providing guidance and resources for career development.
*The company reserves the right to add or change duties at any time.
Job Qualifications & Skills
- Bachelors in Life Science
- A minimum of 15 years of experience with expertise in the areas of clinical operations development and strategic planning; developing, implementing, and leading early to late-stage clinical trials.
- Experience conducting clinical in oncology
- In-depth understanding and experience across the clinical operations value chain, with a track record of success in study planning, execution, data cleaning, database locking, study report generation and regulatory inspection.
- Experience in developing protocols, SOPs, Clinical Study Reports, INDs, NDAs, as well as other clinical, regulatory, and safety documents preferred.
- Expertise in clinical operations – demonstrated ability to effectively manage projects and people.
- Strong communication and presentation skills-demonstrates strong written and verbal communication skills and ability to relay vision/strong sense of department organization.