Senior Manager/Director Clinical Operations

Position Summary

The Senior Manager/Director Clinical Operations will be responsible for oversight and management of up to 2 early phase clinical programs in collaboration with the selected Clinical Research Organization (CRO).

Primary Responsibilities:

• Create and execute clinical operational strategic plans in line with product strategy and resource allocation.
• Develop study feasibility, cost estimates, input into contracts, work/change orders and analyze tools and processes to support outsourcing efforts.
• Track clinical program study finances and monthly accruals and review/approve associated clinical site and vendor invoices.
• Build, develop and train internal staff and external vendors, structure department for enhancing efficiency, and create a highly engaged work environment for attracting and retaining highly qualified clinical operations professionals.
• Develop and ensure compliance with SOPs and guidelines, FDA regulations and current ICH GCP guidelines.
• Oversee and maintain the relationships with Contract Research Organizations, vendors, and investigative sites.
• Participate on clinical operations and study team meetings.
• Maintain a high level of professional expertise through familiarity of clinical literature, knowledge of therapeutic area, current medical practice and pharmaceutical regulations.

Additional Expectations

• Although a remote position, it may be necessary to travel to corporate headquarters up to 2 times per year.
• Ability to travel to clinical sites or to the CRO, as necessary to support trial management.

Qualifications:

• B.A/B.S required; M.S., PhD, PharmD, MD or other related advanced scientific degree strongly preferred.
• Minimum of 7 years for manager and 12 years for director level with progressive advancement within clinical operations in the pharmaceutical/biotech industry.
• Flexible and dynamic interpersonal approach, entrepreneurial by nature, a collaborative team player who works well with physicians, scientists, managers, peers, and staff.
• Ability to manage in a consensus environment through teamwork, trust and shared expectations, influencing strategic direction of complex global clinical operations issues, solicit information, listen well, persuade others, make important decisions and shape outcomes.