Lycia Therapeutics

Senior Manager/Director Clinical Operations

South San Francisco · Director

Sponsorship not specified$169k-$250kDetected 5 days ago

GCPProduct StrategyClinical TrialsClinical ResearchFDA RegulatoryResearchCollaboration

About the role

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).
Track clinical program study finances and monthly accruals and review/approve associated clinical site and vendor invoices.
Participate on clinical operations and study team meetings.

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.
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.
Ability to travel to clinical sites or to the CRO, as necessary to support trial management.
These proteins drive a wide range of difficult-to-treat diseases, including autoimmune and inflammatory conditions.

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.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. Lycia and other biotech companies have recently noticed an increase in email and social media scams targeting job candidates in our industry. Please note Lycia will post any legitimate job openings directly on our website or through our recruitment partner, Lever. If you wish to verify the legitimacy of a job opening, you may contact us.

B.A/B.S required
M.S., PhD, PharmD, MD or other related advanced scientific degree strongly preferred.

Although a remote position, it may be necessary to travel to corporate headquarters up to 2 times per year.

Maintain a high level of professional expertise through familiarity of clinical literature, knowledge of therapeutic area, current medical practice and pharmaceutical regulations.

Lycia Therapeutics is a biotechnology company using its proprietary lysosomal targeting chimera (LYTAC) platform to discover and develop best-in-class therapeutics that degrade extracellular and membrane-bound proteins.

This listing is sourced directly from Lycia Therapeutics's careers page and normalized into a canonical job model.