Job Title: Senior Manager, Clinical Trial Liaison
Reports To: Associate Director, Clinical Trial Liaison
Functional Area: Clinical Operations
Position Location: Remote (possible hybrid)
Exempt/Non-Exempt: Exempt
About Tourmaline Bio, Inc.
We are a nimble, driven and accomplished team of entrepreneurs, physicians, and industry experts with 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 program has completed multiple Phase 1 and Phase 2 clinical trials. We launched our Phase 2b clinical trial in Thyroid Eye Disease (TED) in 2023 and our Phase 2 clinical trial in cardiovascular disease in Q2 2024. We plan to initiate our Phase 3 clinical trial in TED later in 2024. More information about Tourmaline can be found at www.tourmalinebio.com.
General Responsibilities:
The Senior Manager, Clinical Trial Liaison (CTL) is a critical part of the Clinical Operations function and plays a central role in fostering strong relationships with our clinical trial investigators and clinical sites globally. This position provides an opportunity for an experienced medical or clinical research professional to expand and develop their skill set and become a site-facing subject matter expert for our products. Primary responsibilities of this position include providing sponsor oversight of site-facing activities and engaging with Principal Investigators (PIs) and site personnel, in person and remotely, to educate, support and serve as the face of Tourmaline for our clinical trials. This is a field-based position covering a global clinical trial footprint through a mix of live and virtual channels.
Responsibilities:
- Investigational site engagement and education:
- Establish, cultivate, and maintain relationships with PIs and site personnel
- Develop and deliver presentations to PIs, site personnel, referral partners, and advocacy groups in a compliant manner
- Provide support for unsolicited medical inquiries
- Provide support to clinical trial sites
- Support startup activities by working with the site and CRO to ensure a high-quality site experience which may include assisting with site identification, pre-study visits, site specific recruitment plans/calls, site initiation visits, documentation, and regulatory submissions
- Contribute to and drive patient enrollment and patient retention strategies, including continuous monitoring and evaluation of enrollment and retention against site recruitment plans
- Ensure site has everything necessary to successfully enroll participants for the study
- Connect site staff with appropriate Tourmaline and CRO points of contact, as needed
- Oversight and support to site-facing teams
- Review site issues and protocol deviations with CRO/CRA to identify trends and help develop mitigations, identify training needs, and potential study considerations
- Assist in development and review of study manuals, study plans, site facing documents, webinar/training content, etc.
- Conduct clinical trial site visits in-person or virtually, as needed, with a focus on identifying and solving site barriers to enrollment
- Participate in company and function-specific process improvement initiatives
- SOP development and review
- Tracking CTL site/enrollment impact
- Assist with researching national meetings for study indications, facilitating company attendance where appropriate, and facilitating meetings with company and KOL/PI attendees
- Track and report on clinical trial competition in Tourmaline’s therapeutic areas
- Gather scientific insights that contribute to Clinical Development strategies
Education:
- Bachelor’s degree required
- Advanced degree is preferred (e.g., RN, NP, PA, PharmD, PhD, MD, or equivalent)
Experience and Attributes:
- Minimum 7 years of clinical trial experience in a biotech, pharmaceutical, CRO, or clinical research site with at least 3 years as a CTL, MSL, Patient Engagement/Recruitment Lead, Lead CRA or Clinical Trial Manager.
- Experience in autoimmune disease is preferred.
- Strong ability to present, in person or virtually.
- Self-starter with ability to work autonomously.
- Strong working knowledge of cGCP / ICH guidelines, and US and international clinical regulatory requirements.
- Excellent analytical, negotiation and drafting skills, with strong oral and written communication skills.
- Willingness to work hard in a dynamic environment with changing priorities.
- High level of integrity, ethics and discretion.
- Demonstrated ability to prioritize multiple tasks from multiple parties and work in a fast-paced environment with tight deadlines.
- A good team player with solid record of collaboration within and across functional areas.
- Periodic travel to the Tourmaline office in New York or to other locations is required.
- Ability and willingness to travel to clinical sites, including outside of the United States. Travel is currently estimated to be approximately 25-50%.
Base Salary Range:
$138,000 to $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.
