Sr. Director, Clinical Operations – 1625 - San Diego, CA | Biospace
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Sr. Director, Clinical Operations – 1625

AnaptysBio, Inc.

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Location:
San Diego, CA
Posted Date:
8/30/2017
Position Type:
Full time
Job Code:
1625
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Clinical Operations, Director,

Job Description


This position leads clinical operations programs, within the growing AnaptysBio portfolio, providing vision, management, and daily execution.  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.  Specific responsibilities include:

•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 AnaptysBio 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

Requirements


Qualifications

•BA/B S in related scientific or healthcare field and 15+ years of progressive clinical operations experience gained working in pharmaceutical or biotechnology industry environment, with a preference for antibody/biologics experience, including supervisory experience managing clinical operations staff.
•Experience in a hands-on early development role within a small organization is a plus.
•Proven track record of evaluating, selecting, budgeting, directing and managing CROs, central laboratories, and other clinical study vendors.
•Proven track record of planning, conducting & managing clinical operations for Phase 1-3 studies
•Experience managing the clinical operations for drug across multiple therapeutic areas is a plus
•Demonstrated ability to handle a high volume of highly complex tasks within a given timeline
•Track record of leading a cross-functional team in a matrix environment
•Demonstrated, effective planning and project management skills, including risk assessment, contingency planning and ability to prioritize.
•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.
•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
•Expertise in the areas of drug development, operations, and strategic planning, specifically management of clinical trial operations.
•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.
•Excellent organizational and problem solving skills with the capacity to organize assignments and work within deadlines
•Position may require occasional evening and/or weekend commitment
•Position may require occasional domestic and international travel