Senior Director/Vice President, Development Project Leader

5 days ago

Cambridge, Massachusetts, United States Repertoire Immune Medicines Full time
Job Title: Senior Director/Vice President, Development Project Leader

Repertoire Immune Medicines is a biotechnology company dedicated to unlocking the power of the human immune system to treat cancer and autoimmune disease. We are seeking a highly experienced Senior Director/Vice President, Development Project Leader to drive the advancement of our TCR bispecific cancer programs from development candidate nomination into early- and late-stage clinical development.

Key Responsibilities:
  • 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, and provide key mechanistic insights.
  • Lead and synchronize a cross-functional team, including R&D, Translational, Regulatory, CMC, and 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 to describe 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 program outcomes and make pivotal decisions to overcome.
  • Stay abreast of market trends, competitive landscape, and emerging technologies to inform decision-making and identify opportunities for innovation.
Qualifications/Experience:
  • Doctoral 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 judgment and reasoning skills to define problems, collect and analyze data, 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, proactive, collaborative-minded individual interested in contributing to excellent research science in an entrepreneurial environment.

Repertoire Immune Medicines is committed to social responsibility and developing an inclusive culture. 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 Immune Medicines is proud to be an Equal Opportunity Employer.

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