Associate Director / Director, Toxicology

Position Overview:

Beam is looking for a highly talented and motivated Associate Director / Director, Toxicology to join our growing Non-Clinical Development team.  The Associate Director / Director, Toxicology will be responsible for the nonclinical safety assessments supporting Beam's discovery and development programs. The right candidate will be responsible and accountable for the design and execution of safety studies for discovery to early/late development programs. Additionally, this role will be accountable for the authoring of documents for regulatory filings.

Responsibilities:

• Work cross-functionally to drive nonclinical safety related activities from discovery through regulatory filings and to commercialization for various programs.
• Develop and oversee the execution of phase appropriate nonclinical safety strategies along with integrated project plans including milestones, timelines, resources and budgets.
• Coordinate interactions with CRO's, in collaboration with the Nonclinical Development Operations group, to ensure delivery of study results and reports consistent with program timelines.
• Provide strategic contribution as the subject matter expert for GLP, non-GLP, and safety pharmacology studies supporting development and platform programs.
• Provide toxicology support for regulatory submissions and interactions with health authorities, including the authoring of nonclinical safety sections of US and international regulatory applications, and help resolve nonclinical safety queries.
• Drive and be accountable for delivery of high-quality safety reports to ensure clinical plans and regulatory filing submissions in multiple markets.
• Serve as the toxicology representative in cross-functional meetings both internally and externally.

Qualifications:

• Ph.D. with 8+ years of scientific experience OR MS with 12+ years of scientific experience. BS with 15+ years of scientific experience in pathology will also be considered.
• Experience with LNPs and/or gene therapies.
• Experience supporting IND-enabling studies.
• Ability to develop and deliver clear and concise presentations for both internal and external meetings.
• In-depth understanding of all aspects of nonclinical safety and experience with regulatory filings.
• Extensive knowledge of relevant FDA and EMEA regulations and processes.
• Demonstrated proven experience in working with CROs for protocol design and study execution.
• Experience working with cross-functional and collaborative project teams.
• Ability to operate effectively within an innovative and science-driven company environment; delivery-oriented, able to inspire others, driven and hands-on with unquestionable integrity and the highest ethical standards.
• Candidates are expected to come onsite 1-3 days per week.