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.