Associate Director Clinical Operations
Proclinical is currently recruiting for an Associate Director of Clinical Operations with a biotechnology company located in San Diego, CA. Successful candidate will lead the clinical operations programs, providing vision, management, and daily execution.
- Contribute to strategic planning to ensure optimized clinical development plans for assigned projects in alignment with company goals.
- Ensure operational feasibility of clinical development plans and scenarios, including development of, and management to, timeline, budget and resource requirements. Ensure all study activities are completed in accordance with country specific ICH GCP, health authority regulations and SOPs.
- Drive clinical research activity including resourcing, staffing, and direction and action plans with investigational sites, CRAs, and CROs.
- Develop, implement and maintain standards across clinical studies within a program including but not limited to new hire training for CTMs/CRCs, tools, templates and CRO manuals
- Determine patient recruitment strategies, operational feasibility and implementation of study/program objectives
- Provide assessment of outsourcing requisites and options to determine appropriate outsourcing selection at the study, program, and corporate levels
- Guide study team in vendor selection; managing vendors throughout the life of all assigned clinical projects. Propose vendors to senior management for approval.
- Coordinate the preparation and finalization of IND submissions, investigator brochure updates, DSURs, NDA submissions (and/or country-specific equivalents).
- Provide technical expertise for the development of clinical documents, including prioritizing, authoring, and approving study activities (i.e. protocols, monitoring plans, clinical trials report, investigator brochures, etc.) and trial conduct.
- Develop the infrastructure to support advanced clinical trials.
- Coordinate closely with all internal stakeholders to ensure operational excellence.
- Identify and communicate with therapeutic thought leaders for feedback on study protocols, development plans, publications, etc.
- Manage relationship with corporate partners on studies/programs, as applicable, for clinical operations.
Skills and Requirements:
- BA/BS in related life sciences field.
- 10+ years of progressive clinical operations experience in pharmaceutical/drug development, with a preference for antibody/biologics experience, and including 8 years of experience in study/program management.
- Proven track record of planning, conducting & managing clinical operations for Phase 1-3 studies.
- Expert and comprehensive understanding of country specific pharmaceutical standards, FDA, ICH, and GCP requirements (and/or equivalents), principles, concepts, industry practices, and standards, as well as a thorough understanding of cross-functional clinical processes including data management, biostatistics, medical writing, pharmacovigilance, and regulatory affairs.
- Proven track record of evaluating, selecting, budgeting, directing and managing CROs, central laboratories, and other clinical study vendors.
- Experience managing the clinical operations for drug across multiple therapeutic areas is a plus.
- Expertise in the areas of drug development, operations and strategic planning; experienced with submissions from investigational new drug through new drug application filings and managing pre-clinical through all clinical phases.
- Thorough knowledge of data management, data review and analysis, and drug safety and pharmacovigilance.
- Ability to work effectively in as a team player in a complex, changing environment, intensely committed to success and getting the job done well.
- Self-motivated, independent, and results oriented.
- Excellent organizational and problem-solving skills with the capacity to organize assignments and work within deadlines.
- Exceptional attention to details.
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 Natasha Patel at (+1) 617-778-7319 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.