Reports To: Director, Clinical Operations
Functional Area: Clinical Operations
Position Location: Remote (possible hybrid)
Exempt/Non-Exempt: Exempt
We are a late-stage clinical biotechnology company with a nimble, driven and accomplished team of entrepreneurs, physicians, and industry experts on a mission to thoughtfully develop transformative medicines that dramatically improve the lives of patients with life-altering immune and inflammatory diseases. Our core values help drive this mission and are the foundation of our company culture: we have a passion for our mission; we believe respect and inclusion are core to the success of our team; we overcome obstacles to deliver results for patients; and we push the envelope.
Our lead asset is pacibekitug, a long-acting, fully-human, anti-IL-6 monoclonal antibody with best-in-class potential and differentiated properties, including a naturally long half-life, low immunogenicity, and high binding affinity to IL-6. Excluding ongoing trials, pacibekitug was previously studied in approximately 450 participants, including patients with autoimmune disorders, across six completed clinical trials. Tourmaline is currently developing pacibekitug in atherosclerotic cardiovascular disease (ASCVD) and thyroid eye disease (TED) as its first two indications, with plans to expand into abdominal aortic aneurysm (AAA) and additional diseases in the future. In May 2025, Tourmaline announced positive topline results from the ongoing Phase 2 TRANQUILITY trial evaluating pacibekitug in patients with elevated high-sensitivity C-reactive protein and chronic kidney disease.
More information about Tourmaline and pacibekitug can be found at www.tourmalinebio.com.
General Responsibilities:
The Senior Clinical Trial Manager (Senior CTM), in consultation with and support from Clinical Operations leadership, is responsible for all day-to-day operational aspects of a clinical study from setup through final report. The Senior CTM coordinates the activities of other in-house and clinical team members (e.g., Clinical Trial Associates, Data Managers, Supply Chain, etc.), as well as external clinical vendors and/ or consultants. The Senior CTM also assumes the role of the in-house Lead Clinical Research Associate for a study, as needed.
Responsibilities:
- Lead and manage all operational aspects of assigned clinical trials (Phase 1–3), including CRO/vendor oversight, site management, study timelines, budgets and deliverables
- Serve as the primary point of contact for internal stakeholders, CROs, and other external vendors for assigned trial(s)
- Proactively identify risks, issues, and roadblocks, and implement data-driven solutions before they impact trial progress
- Apply strong critical thinking to interpret complex clinical and operational issues, escalate as appropriate, and lead cross-functional problem-solving efforts
- Monitor study progress using key performance indicators (KPIs) and metrics to ensure adherence to protocol, GCP, and regulatory requirements as well as the project budget
- Be accountable for departmental quarterly metrics
- Participate in protocol development, site selection, feasibility assessments, ICF review, and other essential documents
- Collaborate closely with cross-functional partners including Regulatory, Program Management, Biostatistics, Data Management, and QA to ensure seamless execution
- Lead the development of study tools, training materials, site communications, and trial management plans
- Develop and manage clinical trial budget and facilitate contract review with Legal and vendor partners
- Monitor CRO and vendor adherence to scope of work (e.g. confirmation of units consumed, oversight of milestone and deliverable schedule)
- Participate in vendor, site and CRO audits as appropriate
- Participate in site monitoring visits as necessary
- Plan and present at investigator meetings, company, and other meetings as necessary
- Develop internal tracking and reporting tools for reporting study status to leadership and facilitate internal and external project team meetings
- Adhere to relevant company policies and SOPs, cGCP/ICH guidelines, QC/QA procedures, as well as relevant clinical regulatory requirements
Education:
- Bachelor’s degree in a scientific discipline is required
- Advanced degree or certification is a plus
Experience and Attributes:
- 5+ years of clinical trial operations experience in a biotech, pharmaceutical, CRO, clinical research site or related healthcare company
- Experience working on a multi-phase clinical program
- Regulatory Authority Inspection experience preferred
- Robust understanding of the drug development process
- Highly organized, outcome-oriented, self-motivated performance
- Ability to analyze complex issues objectively, using relevant KPIs, and applying a data-driven mindset, to develop and recommend trial-related plans, mitigations, and solutions.
- Ability to thrive in a fast-paced and evolving environment
- High level of integrity, ethics, and discretion
- Excellent interpersonal skills, ability to develop important relationships with key stakeholders across a variety of disciplines, good conflict management and negotiation skills
- Strong working knowledge of cGCP/ICH guidelines, and US and international clinical regulatory requirements
- Strong written and oral communication skills
- Comfortable navigating ambiguity and adapting quickly to shifting priorities
- Excellent problem-solving and decision-making skills with a “roll-up-your-sleeves” mindset
- Ability to work East Coast business hours, regardless of primary work location
- Periodic travel to the Tourmaline office in New York, and other travel related to project meetings and/or team meetings, may be required
- Ability and willingness to travel domestically and internationally (10-20%)
Base Salary Range: $138,000 – $165,000, based on candidate professional experience level.
Note:
This job description is written as a guideline to inform a current or prospective Tourmaline employee of what is or will be generally expected in a given position. The description is not intended to be all-encompassing or limiting in any manner. Duties and responsibilities other than those listed above may be included as needed.
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Tourmaline Bio, Inc. is proud to be an equal opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other protected characteristics under applicable law.
