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
