Job Title: Director, Clinical Operations
Reports To: SVP, Product Development
Functional Area: Clinical Operations
Position Location: Remote (possible hybrid)
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 first clinical trial in Thyroid Eye Disease (TED) in Q3 2023 and plan to initiate additional clinical trials in 2024, one of which is expected to be in cardiovascular disease. More information about Tourmaline can be found at www.tourmalinebio.com.
The Director, Clinical Operations works alongside seasoned professionals to build a world-class clinical operations function from the ground up, from strategy through execution. Primary responsibilities include hands-on management of all aspects of clinical trial planning and execution, overseeing work performed by outside vendors, and leading groups of internal and external clinical operations personnel to achieve company objectives.
- Contribute to the growth and development of a best-in-class Clinical Operations function, including hiring and team development, selection and implementation of optimized systems and processes, and management of clinical budgets for designated programs.
- Develop and implement clinical project plans and timelines aligned with corporate objectives with a focus on operational excellence.
- Oversee clinical trial activities from study start-up through database lock and final study report for one or more clinical programs.
- Ensure that compliance, quality and timeline objectives are met for all trials executed globally.
- Contribute to key study documents (e.g., protocols, IBs, SAPs, CSRs, etc.) in conjunction with other functions.
- Manage clinical trial resources and reforecasting projections.
- Ensure clinical trial compliance with all SOPs and cGCP/ICH guidelines.
- Work cross-functionally to ensure alignment of activities and interdependencies.
- Proactively identify, resolve and escalate issues that jeopardize clinical study completion on time or within budget.
- Provide regular study updates to Tourmaline leadership and represent Clinical Operations in strategic initiatives across the organization.
- Recruit, hire, and successfully manage Clinical Operations professionals to ensure effective execution of clinical project plans and corporate objectives.
- Provide leadership, vision and professional development opportunities to your team.
- Bachelor’s degree or higher required; advanced degree preferred
Experience and Attributes:
- Minimum 10 years clinical trial management experience in a biotech, pharmaceutical, CRO, clinical research site or related healthcare company
- Experience building and managing a high performing Clinical Operations team
- Hands on experience running global clinical trials
- Excellent interpersonal skills, strategic thinking, high emotional intelligence and the ability to develop important relationships with key stakeholders across disciplines
- Thorough 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 Tourmaline offices in New York and physical attendance at other project and team meetings may be required.
Base Salary Range:
$190,000 to $240,000, based on candidate professional experience level.
If you have a passion for our mission at Tourmaline, we would love for you to join our team. To apply for any of our open positions, email your resume to email@example.com. Be sure to include the title of the position of interest in your email.
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.