Senior Director/Vice President, Development Project Leader

1 day ago

Cambridge, Massachusetts, United States Repertoire Immune Medicines Full time
Job Description

Repertoire Immune Medicines is a biotechnology company dedicated to unlocking the potential of the human immune system to treat cancer and autoimmune diseases. The company's innovative DECODE platform enables in-depth characterization of TCR-antigen pairs, allowing for the development of novel targeted immune medicines. Our team is advancing a pipeline of DECODE-enabled immune medicines, including TCR bispecific molecules for cancer treatment and mRNA tolerizing vaccines for autoimmune diseases.

Key Responsibilities
  • Lead the planning and execution of TCR bispecific molecules from late-stage preclinical discovery through clinical development.
  • Develop translational plans to enable patient selection and stratification, early markers of clinical activity, and mechanistic insights.
  • Collaborate with cross-functional teams 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 clear 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.
Qualifications/Experience
  • Doctoral level degree required (e.g. PhD, MD or PharmD).
  • Experience in immuno-oncology clinical development preferred, with a focus on protein therapeutics and TCR-based therapeutics.
  • Minimum 10-15 years of program leadership experience within the biotechnology or pharmaceutical industry.
  • Extensive experience with programs in preclinical and clinical development, including regulatory submissions and agency interactions.
  • Comprehensive understanding of the entire drug development process, including regulatory environments, clinical development, and CMC.
  • Strategic thinking and problem-solving abilities, with a proven track record of 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.
  • 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.

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