Executive/vp Medical Director

Flare Therapeutics is a biotechnology company pioneering a new therapeutic space with a novel approach to decipher the biology of transcription factors to develop small molecule medicines. Based on insights from the seminal work of its scientific founders, our team has uncovered ‘switch sites,’ druggable regions that are key targets for transcription factor regulation, to address mutations that cause disease. Our drug discovery efforts to target switch sites has rapidly advanced, resulting in an emerging pipeline of research programs that address well-validated, genetically defined transcription factors, initially focused on precision oncology with future potential in neurology, rare genetic disorders, immunology and inflammation, and obesity.   We are a collective of brilliant fires, trailblazing a path to conquer transcription factors and create cutting-edge medicines for patients. We embrace diversity in all its forms, experiences, and viewpoints. We are inspired by the unknown and willing to take risks. We are passionate about the science we pursue and compassionate about the patients it stands to benefit. And we respect, value, and believe in each other.

In this role you will…

• Lead the design and execution of strategic clinical development plans with the Chief Medical Officer and cross-functional clinical development sub-team(s) to evaluate clinical proof of concept, reach value creation milestones, and generate pivotal data
• Strategize, design, and write target product profiles, in collaboration with other functional representatives, to support competitive asset positioning, clinical development, global approval and commercialization of innovative medicines
• Represent the clinical development function at or lead cross-functional project teams
• Be the accountable physician scientist designing, implementing, and analyzing Phase 1-3 oncology clinical trials for one or more programs
• Participate in or lead interactions with global regulatory authorities, including authoring briefing documents, attending in person meetings, and contributing to IND, CTA, IDE, expedited pathway, 510(k), PMA, NDA, and/or MAA filings
• Be the accountable study responsible physician for Phase 1-3 oncology clinical trials, ensuring compliance with applicable regulations, the integrity of study conduct, and patient safety; this responsibility includes in-depth review of clinical and translational data and a fluent knowledge of patient-level data
• Direct protocol development and oversee authorship of associated study documents in collaboration with other functions
• Partner with clinical operations to select and oversee CROs to implement clinical trials within the expected scope, budget, and timelines
• Collaborate effectively with research, early development, and translational development functions in the development of IND-enabling studies, and biomarker plans to demonstrate proof of mechanism, support dose selection, and select patients likely to respond to investigational agents
• Advise on development of the companion diagnostics in the design and implementation of studies to support IDE, 510(k), and PMA filings, or their global equivalents
• Develop productive relationships and scientific dialogue with external experts to guide the research and development of innovative medicines and companion diagnostics
• Represent the scientific progress of clinical-stage projects to the executive leadership team, external advisory boards, and Board of Directors
• Write, review and present scientific and clinical data at medical conferences and in medical journals
• Manage either directly or indirectly clinical scientist(s), medical director(s), biostatisticians, and clinical operations professionals, as well as project teams or study teams, when there is an agreed project/business need
• Effectively represent clinical development in the presentation or assessment of clinical programs and data for business development initiatives
• Travel up to 25% of your time, as required to fulfill your responsibilities

About you…

• You have a MD or foreign equivalent
• You have current or prior board certification in hematology or medical oncology, or foreign equivalent
• You bring expertise in the design and conduct of early- and late-stage oncology clinical trials at an industry sponsor or academic site
• You bring expertise in the review, interpretation, and communication of clinical data
• You have experience negotiating clinical development plans and a track record of successful interactions with regulatory authorities
• You have a record of successfully leading submission and defense of NDA’s, BLA’s, or MAA’s
• You bring strong scientific acumen as demonstrated by a PhD or post-graduate research, and a strong publication record in top-tier journals
• You have the ability to effectively participate in and/or lead multi-disciplinary teams and to function independently
• You have excellent written and verbal communication skills
• You have the ability to actively listen and effectively prioritize, with appropriate attention to detail
• You bring exceptional analytical and problem-solving abilities
• You have working knowledge of GxP, ICH, and applicable regulatory guidelines