VP Clinical Operations
Proclinical is currently recruiting for a VP of Clinical Operations for a pharmaceutical company located in New York, NY. Successful candidate will be responsible for overseeing and coordinating the operational aspects of ongoing projects to ensure that corporate goals including timing, cost and quality performance meet expectation.
- Establish and implement strategic vision for Clinical Operations, including working with third party CROs and vendors. Establish and maintain strong relationships with CROs, external experts and investigators to ensure effective execution of internal and external clinical projects
- Develop and implement an efficient CRO oversight process, with clear documentation for work performed as well as any escalation process
- Implement performance indicators to ensure successful execution of clinical trials according to established timelines; ensure the highest standards for compliance with Company SOPs, ICH-GCP guidelines, regulatory authority regulations and patient safety standards
- Accountable for the authorship of operational sections of protocols and investigator brochures and leading the identification of and interaction with investigative sites and investigators, including study execution
- Develop and implement study feasibility processes to enhance clinical trial execution and risk mitigation plans
- Report status and metrics for progress of clinical trials
- Lead & mentor Clinical operations staff to support successful internal training and its implementation and serve as an advocate for professional development of Clinical Operations staff
- Provide support for regulatory submissions, supporting dossier development and participating in interactions with FDA, EMA and other regulatory agencies
- Mentor clinical operations staff on the Regulatory Inspections process and develop a pro-active approach for Inspection readiness
- Help create Clinical Trial budgets and progress reports; complete other administrative tasks as required or assigned by the CEO
- Oversee and trouble-shoot clinical development program challenges, processes and activities with direct reports
- Design, develop and implement risk evaluation and mitigation strategy as it pertains to the conduct of clinical trials and key milestone deliverables
- Facilitate Investigators and Medical/Scientific Advisory
Skills and Required:
- BA/BS, MS, PharmD, PhD or equivalent in a scientific discipline is preferred
- 20+ years of progressively more challenging work experience in clinical and drug development, including 10+ years of Clinical Operations line management experience
- Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH GCP Guidelines regarding drug development phases, clinical trials, clinical study design, and data management methods
- Thorough knowledge of regulatory requirements such as NDA filing is preferred; experience in developing protocols, SOPs, INDs, NDAs, as well as other global regulatory and clinical guidelines or laws
- 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
- Extensive experience managing Clinical Operations staff and optimizing resources across clinical studies
- Proven experience with clinical operations line management, focusing on developing, managing performance and coaching of staff
- Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the organization
- Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and/or organizational goals
- The successful candidate should be a results-oriented, team player with strong interpersonal and communications skills, capable of working collaboratively with colleagues
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Nicole Aganon at (+1) 347-293-1161 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.