Associate Director Clinical Operations
BioSpace has been engaged to help our client find a leader to oversee a Phase III project. Program(s) goals, milestones and deliverables are achieved via a close interaction and collaboration with all functional lines involved in clinical development. Responsibilities include operational leadership and successful execution of clinical trials according to regulatory guidelines, oversight of timelines, budgets, resources, clinical trial sites, vendors and key project deliverables; oversight and continuous improvement of department infrastructure through the development of SOPs, guidelines and the use of technology; facilitation of effective internal and external relationships, and achievement of project goals and objectives.
- 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 company 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.
Knowledge and Competencies
- 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.
- Thorough knowledge of data management, data review and analysis, and drug safety and pharmacovigilance.
- Effective communication and interpersonal skills, with the ability to successfully articulate strategies, experimental results and analysis to various constituents such as governance committees, project teams, clinical sub-teams, and senior management to build enthusiasm and commitment, and to gain approval/sponsorship for projects. Listens and seeks clarification; responds effectively to inquiries or complaints.
- 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
Education & Experience
- 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.
- 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.
- International experience is highly preferred.
- Track record of leading a cross-functional team in a matrix environment.
- Willingness and capability to work effectively in a smaller pharma company (i.e. willing to roll-up your sleeves as necessary to help get the job done).
- Experience in a hands-on early development role within a small organization is a plus.
- Demonstrated ability to handle a high volume of highly complex tasks within a given timeline.
- Demonstrated, effective planning and project management skills, including risk assessment, contingency planning and ability to prioritize.