Senior Manager/Director Clinical Operations

 Posted 5 days ago
     
 $180K - $250K per year
  
10+ years experience
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AI Summary

Oversee and manage early phase clinical programs in collaboration with Contract Research Organizations (CROs). Responsible for strategic planning, financial tracking, and ensuring compliance with FDA and ICH GCP guidelines.

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. These proteins drive a wide range of difficult-to-treat diseases, including autoimmune and inflammatory conditions. Lycia was established in 2019 in collaboration with academic founder and Nobel Laureate Carolyn Bertozzi, Ph.D., professor of chemistry and HHMI investigator at Stanford University. In June, 2026, Lycia Therapeutics completed a $75 million Series D financing to advance its pipeline of LYTAC extracellular protein degraders into the clinic. Lycia is headquartered in South San Francisco. 

 

Visit https://lyciatx.com/ for more information.


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).   

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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.


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$180,000 - $250,000 a year
The expected base salary range for the Senior Manager is $180,000-$198,000 and for the Director is $225,000-$250,000. We encourage candidates of all levels to apply as there is often flexibility on job title and responsibilities. Compensation will be based on a variety of factors, including experience, qualifications and internal equity. Lycia offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package.
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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.

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