Vice President, Medical Research at Tourmaline Bio

Tourmaline Bio seeks an experienced Vice President of Medical Research (VP) to join their growing team. The VP will be a core member of the Medical Research (Clinical Development) team and will contribute to devising the overall clinical strategy and formulating clinical development plans. The VP will own medical activities within clinical development, including providing medical monitoring and oversight of clinical trials, authoring sections of regulatory documents, supporting pharmacovigilance activities, building relationships with external experts and patient advocacy groups, and writing abstracts and publications with medical affairs and medical writing support. The ideal candidate will have the following mix of personal and professional characteristics:

• MD with board certification in internal medicine
• 10+ years of clinical trial experience including 5+ years in industry with a focus on inflammatory/autoimmune diseases
• Experience with early- and late-stage clinical development programs
• Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols

COMPANY OVERVIEW

Tourmaline Bio is a late-stage clinical biotechnology company driven by their mission to develop transformative medicines that dramatically improve the lives of patients with life-altering immune and inflammatory diseases. In doing so, Tourmaline seeks to develop medicines that have the potential to establish new standards-of-care in areas of high unmet medical need.

Tourmaline’s product candidate, TOUR006, is a long-acting anti-IL-6 antibody that exhibits best-in-class properties, including a high binding affinity to IL-6 and a long half-life. The anti-IL-6 and anti-IL-6 receptor (IL-6R) antibody class has over two decades of clinical experience, treating over a million patients with a variety of autoimmune and inflammatory diseases. TOUR006 has been studied in approximately 450 study participants with autoimmune disorders and healthy volunteers and has demonstrated deep inhibition of the IL-6 signaling pathway with relatively low amounts of drug exposure and delivery as an infrequently administered, low-volume, subcutaneous injection.

Tourmaline’s strategy is to develop TOUR006 in indications where IL-6 pathway inhibitors have been underexplored despite compelling signals of clinical activity, taking a human data-focused approach to indication selection. Tourmaline seeks to leverage published observations of IL-6 pathway inhibitors in various diseases as well as insights from clinical trials of competitor IL-6 pathway inhibitor programs to maximize the therapeutic potential of TOUR006. The extensive clinical experience with TOUR006 to date allows Tourmaline to move directly into late-stage/pivotal programs to rapidly deliver TOUR006 to patients.

THE POSITION

Key responsibilities include:

• Formulate clinical development plans that integrate scientific rationale, clinical need, clinical measurement approaches, statistical rigor, regulatory and payor requirements, and company strategy
• Lead the design and execution of clinical trials for autoimmune/inflammatory diseases in collaboration with cross-functional partners
• Provide medical monitoring and oversight for clinical trials in autoimmune/inflammatory diseases
• Support medical evaluation of individual case safety reports, including review of narratives and source documents related to serious adverse events (SAEs) and events of special interest (AESIs)
• Provide medical insights during the review of periodic reports, signal evaluation reports, and ad-hoc safety reports
• Chair the Safety Management Committee for their studies, leading the strategic oversight of safety issues and decision-making processes
• Engage proactively in signal detection and risk management, including analysis and interpretation of safety data trends, and developing risk mitigation strategies
• Collaborate across all levels in the organization
• Serve as a content expert in the review of abstracts, publications, medical information letters, and other medical documents as needed
• Provide medical input into regulatory document preparation
• Lead content development for advisory board meetings
• Build relationships with key external stakeholders including expert physicians and patient advocacy groups
• Participate in the overall portfolio decision-making for the company

The ideal candidate will have the following mix of personal and professional characteristics:

• MD with board certification in internal medicine
• 10+ years of clinical trial experience including 5+ years in industry with a focus on inflammatory/autoimmune diseases
• Ability to run a complex clinical research program with minimal direction
• Demonstrated ability to work effectively with colleagues from multiple cultures, backgrounds, and geographies
• Demonstration of strong leadership and influencing skills with cross-functional and product development teams
• Experience with early- and late-stage clinical development programs
• Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols
• Ability to effectively communicate project status, science, and strategy to a wide variety of internal audiences
• Ability to effectively communicate externally through conference presentations, publications, investigator meetings, and regulatory interactions
• Ability to travel up to 20%