Senior Scientist, Toxicology

Crescent Biopharma , Inc. • Waltham, MA

9d • $190,000 - $212,000

About The Position

The Senior Scientist, Toxicology will be responsible for the design, leadership, and implementation of nonclinical safety strategies across Crescent’s research and development programs. This position will report to the Sr. Director of Toxicology. This role requires experience designing and executing the breadth of nonclinical safety studies to support lead candidate selection through product registration, and a demonstrated ability to make data-driven decisions based on nonclinical and clinical information.

The ideal candidate is a creative and innovative scientist who has led nonclinical safety efforts for the successful discovery and development of protein therapeutics across biologics modalities, such as monoclonal antibodies and antibody drug conjugates. This individual will work in close collaboration with colleagues in Clinical Development, Translational Sciences, Bioanalysis, Project Management, Research, and Regulatory Affairs to execute the company’s overall development strategy, participate on cross-functional project teams, and contribute to interactions with global health authorities.

This role provides the rare opportunity for a growing professional to develop their skills through collaboration, while making strategic and tactical impact on the things that matter most – driving our science to help patients.

Requirements

• Ph.D. or equivalent training in toxicology or related disciplines with at least 5 years of bio/pharmaceutical industry drug development experience in nonclinical safety/toxicology.
• Strong understanding of toxicology principles, the drug development process and regulatory guidance to support nonclinical safety strategies for first-in-human (FIH) studies through product registration.
• Experience with preparation of the clinical pharmacology portions of regulatory documents such as the pre-IND, IND, IB, FIH starting dose justifications, briefing documents, nonclinical study reports, CTA and filing documents, while working in collaboration with cross functional teams.
• Experience supporting regulatory submissions for small molecules, biologics, and ADCs preferred, with a focus on nonclinical and clinical development global strategy and execution.
• Demonstrates good judgment and the ability to make thoughtful, well-reasoned decisions.
• Able to evaluate information, identify issues, and develop practical solutions.
• Highly organized with strong attention to detail and accuracy.
• Works effectively across teams and disciplines, building strong relationships and aligning stakeholders toward shared goals.

Nice To Haves

• Experience supporting regulatory submissions for small molecules, biologics, and ADCs preferred, with a focus on nonclinical and clinical development global strategy and execution.

Responsibilities

• Lead the nonclinical safety strategy with vision to create scientifically sound, innovative and efficient programs that meet regulatory requirements, corporate and R&D program goals, and facilitate expedient development from discovery research to Phase 1 and on to registration.
• Independently represent Toxicology as a member of program, nonclinical, and clinical trial working teams
• Contribute to candidate selection strategy and design, execute, and finalize nonclinical study reports.
• Partner with the discovery group and work with clinical pharmacology colleagues to optimize nonclinical models and inform first in patient clinical dosing strategies.
• Review nonclinical study reports, in conjunction with Pharmacology / DMPK and prepare submission documentation.
• Adhere to agreed timelines and budgets to ensure execution of deliverables from nonclinical safety studies and programs.
• Collaborate across functions to support corporate objectives.

Benefits

• medical
• dental
• vision
• life insurance
• short- and long-term disability
• savings plan (401(k))
• long-term incentive program
• Vacation – Unlimited PTO
• Sick time – 10 days per calendar year
• Holiday pay, including two Company shut downs
• Parental Leave – 16 weeks within one year of the birth/adoption/foster care of a child
• FMLA
• Military Leave

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree