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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