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Senior Director/Vice President, Development Project Leader
2 months ago
We are seeking an experienced Senior Director/Vice President, Development Project Leader to join our team at Repertoire Immune Medicines. As a key member of our R&D organization, you will be responsible for driving the advancement of multiple 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 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.
- 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 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 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. We are committed to pursuing a diverse workforce and creating an inclusive culture that values creativity and ingenuity.
We are proud to be an Equal Opportunity Employer and are committed to social responsibility.
