Senior Director/Vice President, Development Project ...

Senior Director/Vice President Development Project LeaderRepertoire Immune Medicines is a biotechnology company working to unlock and direct the remarkable power of the human immune system to treat cancer and autoimmune disease. The company was founded on the belief that understanding the repertoire of T cell receptor (TCR)-antigen immune synapses that maintain health and drive disease represents one of the greatest opportunities for innovation in medical science. Repertoire scientists created and developed the DECODETM platform, which allows in-depth characterization of TCR-antigen pairs, and the ability to deploy this information in the form of novel targeted immune medicines to fundamentally reprogram the immune system to kill tumors or induce immune homeostasis.From its sites in Cambridge, Massachusetts and Zurich, Switzerland, Repertoires team is advancing a pipeline of DECODE-enabled immune medicines. For cancer, we are developing a pipeline of TCR bispecifics molecules for treatment of multiple cancer types. In addition, we are developing a pipeline of mRNA tolerizing vaccines for treatment of autoimmune diseases. Repertoire was founded by Flagship Pioneering and is supported by a strong investor base. In addition, the company recently entered a strategic partnership with Bristol Myers Squibb to develop tolerizing vaccines for up to three autoimmune diseases. Role Overview Reporting to the President of Repertoire, this accomplished Senior Director/Vice President Development Project Leader, will drive advancement of multiple TCR bispecific cancer programs from development candidate nomination into early- and late-stage clinical development. The successful candidate will collaborate and partner with cross-functional subject matter experts across Repertoire R&D organization.The successful Development Project Leader candidate has a deep understanding of the drug development process, with special emphasis on protein therapeutics and immune-oncology drug development. Proven successful interactions with regulatory agencies with multiple regulatory submissions is a key requirement for this position. Experience with clinical site set up and engagement with key clinical KOLs to enable patient recruitment is also a key part of the role. This candidate has demonstrated strong leadership skills, the ability to apply innovative translational biology approaches to provide scientific insights, and the ability to think critically. The candidate is expected to be influential across the entire drug discovery spectrum in partnership with all research and translational teams, regulatory, toxicology, CMC and clinical. As the companys Development Lead, you will present program progress and strategies to senior leadership for endorsement in governance forums. The focus will be to deliver and leverage high-quality scientific, translational and clinical data to inform strategy and advance programs consistent with its prioritization in the overall portfolio.Key ResponsibilitiesWorking in conjunction with key R&D leaders, lead and drive the planning and execution of TCR bispecific molecules from late-stage preclinical discovery through clinical development. Build and execute translational plans that allow patient selection and stratification, early markers of clinical activity as well as providing key mechanistic insights. Lead and synchronize a cross-functional team, including R&D, Translational, Regulatory, CMC, Toxicology to align with program objectives.Partner with regulatory consultants and interface with the agency to ensure positive acceptance and approvals of regulatory submissions. Engage with clinical KOLs, describing the platform, preclinical pharmacology and clinical opportunity to enable patient recruitment Maintain a clear channel of communication with senior management and stakeholders regarding program progress, risks, challenges and opportunities. Utilize data-driven insights to navigate the program outcomes making pivotal decisions to overcome. Stay abreast of market trends, competitive landscape and emerging technologies (explorations and scouting) to inform decision-making and identify opportunities for innovation.Qualifications/ExperienceDoctoral level degree required (e.g. PhD, MD or PharmD).Experience in immuno-oncology clinical development preferred with experience in protein. therapeutics essential and understanding of TCR based therapeutics highly desired. Minimum 10-15 years of program leadership experience within the biotechnology or pharmaceutical industry. Extensive experience with programs in preclinical and clinical development required. Experience in regulatory submissions, including INDs/CTAs, and regulatory agency interactions is essential.Comprehensive understanding of the entire drug development process, including in-depth knowledge of regulatory environments, clinical development, and Chemistry, Manufacturing, and Controls (CMC).Strategic thinking and problem-solving abilities, adept at managing complex projects under pressure. Excellent oral and written communication skills, including writing, reviewing and editing scientific documents and presenting to a range of stakeholders.Proven leadership capabilities and ability to lead and motivate cross-functional teams.Excellent judgement and reasoning skills to define problems, collect and analyze, establish facts and recommend a course of action.Strong negotiation and interpersonal skills to lead effective teams and ensure efficient conflict resolution. Strong experience in oversight of clinical studies and study teams across all phases of development.Dynamic, independent, flexible, well-organized, pro-active, collaborative-minded individual interested in contributing to excellent research science in an entrepreneurial environment.Repertoire is committed towards social responsibility and developing an inclusive culture. Much as the power of the immune system lies in the diversity of T and B cells, we believe that our work requires the creativity and ingenuity of a diverse workforce, and we are committed to pursuing that in all facets of the work experience at Repertoire. We will continue to educate ourselves about the inequities and barriers present in our society and act as a company where we can make a difference. Repertoire is proud to be an Equal Opportunity Employer. Recruitment & Staffing Agencies: Repertoire Immune Medicines ("Repertoire") does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Repertoire or its employees is strictly prohibited unless contacted directly by Repertoires internal Human Resources team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Repertoire, and Repertoire will not owe any referral or other fees with respect thereto.

Created: 2024-11-19