Job Title: Vice President, Clinical Operations
Reports To: Senior Vice President, Product Development
Functional Area: Clinical Operations
Position Location: Remote (possible hybrid)
Exempt/Non-Exempt: Exempt
About Tourmaline Bio, Inc.
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 (also known as TOUR006), a long-acting, fully-human, anti-IL-6 monoclonal antibody. Pacibekitug has previously completed multiple Phase 1 and Phase 2 clinical trials. Tourmaline is developing pacibekitug in thyroid eye disease (TED) and atherosclerotic cardiovascular disease (ASCVD) as its first two indications, with additional diseases under consideration. More information about Tourmaline and pacibekitug can be found at www.tourmalinebio.com.
General Responsibilities:
The Vice President, Clinical Operations will provide strategic leadership and oversight to ensure the successful execution of Tourmaline Bio’s clinical programs. Reporting to the SVP, Product Development, this role will manage the Clinical Operations team and lead the development and implementation of Clinical Operations strategies and best practices. The VP will oversee clinical trial planning, execution, and management in alignment with corporate goals, while ensuring adherence to regulatory and Good Clinical Practice (cGCP) standards.
Responsibilities:
- Develop Clinical Operations into an industry-leading, collaborative, and high-performing function.
- Demonstrate “role model” leadership at all times consistent with Tourmaline corporate values.
- Drive the development and execution of clinical strategies in line with corporate objectives.
- Provide strategic guidance of clinical programs from early-stage through pre-commercialization.
- Increase clarity of individual and team responsibilities; champion goal setting and career development throughout the Clinical Operations organization.
- Collaborate with cross-functional colleagues (e.g., Regulatory, Quality, Medical Research, CMC, Legal, Program Management) to ensure seamless integration of clinical operations.
- Lead resource planning and budget management for Clinical Operations, ensuring optimal resource allocation and productivity.
- Ensure all clinical programs are compliant with global regulatory standards, cGCP/ICH guidelines.
- Proactively identify and mitigate and/or escalate issues that may impact clinical study timelines, budgets, or quality.
- In conjunction with Quality, ensure readiness for regulatory inspections and maintain compliance with all internal and external quality standards.
- Foster a high-performance culture focused on clinical excellence, patient safety, and operational efficiency.
- Provide regular updates to the SVP, Product Development, and the executive team as needed, on clinical program progress, risks, and mitigations.
- Provide opportunities for developing skills and fostering innovation, identify opportunities to continuously improve processes and systems.
- Education and Licensure:
- Bachelor’s degree required ; advanced degree in a scientific discipline preferred
Experience and Attributes:
- 12+ years of clinical trial management experience in biotech or pharmaceutical industries, with significant leadership in global clinical operations.
- Proven track record of successfully advancing clinical programs through late-stage trials.
- Experience leading relationships with CROs and other third parties/vendors.
- Strong leadership and team management abilities, with experience mentoring and developing clinical teams.
- Excellent organization, strategic approach, analytical thinking, and problem-solving skills.
- Ability to understand complex scientific ideas and effectively communicate their value proposition to key internal and external stakeholders.
- Proven experience working with US and international clinical regulatory bodies (e.g., FDA, EMA).
- Thorough knowledge of global clinical regulatory requirements and guidelines (e.g., cGCP, ICH).
- High emotional intelligence, with the ability to build strong relationships across the organization.
- Ability to thrive in a dynamic, fast-paced environment with competing priorities.
- Boston area-based candidates strongly preferred, to facilitate face-to-face interactions with the SVP, Product Development and other Product Development team members.
- Regular travel for meetings in Boston and/or New York is required. Required travel is estimated to be 10% for Boston area-based candidates and 20% for candidates located in other geographies.
- Ability and willingness to travel domestically and internationally.
Base Salary Range:
$318,000 – $338,000 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.
