Vice President, Clinical Operations

Position Summary

Reporting to the Chief Medical Officer, the Vice President of Clinical Operations will be responsible for building and leading a team of clinical operations professionals who will oversee the strategy for implementation as well as execution of all AnaptysBio sponsored clinical trials. Working with cross-functional leaders, the successful candidate will ensure the appropriate department infrastructure is in place to support the Company’s clinical trial programs. This individual will be responsible for leading all operational aspects of the Company’s clinical trials conduct from study concept through to report writing in support of license applications.  

Essential Functions

These may include, but are not limited to, the following; other duties may be assigned:

• Provide strategic and technical guidance to ensure clinical trials are properly defined, planned and executed. 
• Anticipate and develop strategic planning activities and ensure translation of strategic decisions into operational plans.
• Leads and directs the clinical operations team responsible for management and execution of all clinical trials. This includes but is not limited to, ensuring spending, cost forecasting, quality, vendors are managed, and timelines of multiple programs are realistically set and met 
• Leads and directs the building of department infrastructure, including developing, training, and retaining the clinical      operations team; ensures prioritization of activities and resourcing is in line with clinical development programs.
• Ensure training and provide guidance to internal and external customers on all aspects of trial feasibility, allocation, tracking and budgeting.
• Contributes to business development activities which includes providing critical due diligence and analysis of potential      Clinical Development programs.
• Ensuring compliance with ICH cGCP, health authority regulations and the Company’s policies and procedures. 
• Optimize and implement SOPs, processes, communication, and infrastructure within Clinical Operations Department to      support company goals including Regulatory filings.
• Establish, develop, and maintain working relationships with suppliers, CROs, PIs, and sites in the execution of Clinical      Development projects. 
• Maintain collaborative relationships with vendors, key opinion leaders, investigators, and other key individuals as necessary      to ensure appropriate program progress and overall business and clinical objectives.
• Partner collaboratively with key internal functions such as Translational Medicine, Pharmacology and Toxicology, Regulatory,      Quality and Program Management to implement the Company’s clinical strategies and drive organizational success.
• Partner and work closely with Finance to develop and manage the Clinical Operation’s forecast, budget, accruals and update      Senior Management on progress and anticipated changes in scope, schedule, and resources in a timely manner.
• Represent Clinical Operation’s plans and status to partners and senior audiences.
• Maintain real-time, live dashboards for management review of program status, risk plans and mitigation, and document control.

Education & Experience: 

• BA/BS in related life sciences field and 20+ years of progressive clinical operations experience in pharmaceutical/drug development and including at least 10 years of strong hands-on experience leading and managing clinical operations team and trials execution, preferably in antibody/biologics experience globally.
• 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. 
• Proven ability to build strong and collaborative relationships with external partners, CROs and vendors including extensive experience managing contracts and clinical finance activities.
• Ability to work independently and collaboratively in a fast-paced environment, team environment consisting of both internal and external team members.
• Excellent interpersonal skills to facilitate/optimize contribution of team members
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent verbal and written communication skills.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Proven track record of planning, conducting & managing clinical operations for Phase 1-3 studies.
• 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.

Knowledge Requirements: 

• Thorough working knowledge across broad range of drug development areas.
• 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.

Other Information:

• Position may require occasional evening and/or weekend commitment.
• Position may require occasional domestic and international travel.

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.