Director of Research Development

Role Overview: We are seeking an experienced leader to oversee our Analytical Development team, responsible for managing a group of talented people leaders who drive critical early-phase programs in oncology development. This position involves guiding teams through method development and validation, as well as stability testing for biologics, including monoclonal antibodies (mAbs) and... antibody-drug conjugates (ADCs).

Key Responsibilities: • Lead a team of direct reports who manage their own teams, ensuring effective collaboration and development of early-phase oncology assets. • Oversee method development, validation, and qualification activities, particularly for IND submissions and analytical control strategies. • Ensure that analytical methods are phase-appropriate and compliant with regulatory requirements. • Facilitate communication and collaboration among cross-functional teams, including product development and external partners. • Drive the strategic growth of the organization by identifying talent and expanding the team to meet increasing project demands. • Engage in challenging conversations and negotiations with stakeholders to align on project goals and expectations.

Qualifications: • Experience: • Significant leadership experience in analytical development, with a focus on biologics (mAbs required; ADCs and gene therapy are a plus). • Proven track record in managing teams through the lifecycle of molecule development, from discovery through IND and clinical proof of concept. • Familiarity with analytical method development and validation processes, particularly in an early-phase R&D environment. • Previous roles as Analytical Lead or CMC Lead in early-phase programs, with strong experience in QC. • Skills: • Exceptional leadership and communication skills, capable of leading a diverse team with varying educational backgrounds and levels of experience. • Strong analytical mindset with an ability to navigate complex regulatory environments. • Proficiency in establishing and maintaining relationships with business partners and stakeholders

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