Crescent Biopharma · 1 day ago
Senior Scientist, Toxicology
Waltham, MA
Full-time
Onsite
Senior Level
$190K/yr - $212K/yr
5+ years expCrescent Biopharma is focused on advancing innovative therapies for cancer patients, and they are seeking a Senior Scientist in Toxicology to lead nonclinical safety strategies. This role involves collaboration across multiple departments to ensure effective development and regulatory compliance for their oncology programs.
BiotechnologyMedical DeviceHealthcareHealth Care
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
Qualification
Required
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
Preferred
Experience supporting regulatory submissions for small molecules, biologics, and ADCs preferred, with a focus on nonclinical and clinical development global strategy and execution
Benefits
100% employer-paid benefits package
Flexible PTO; also, two, one-week company-wide shutdowns each year
A commitment to your professional development, with access to resources, mentorship, and growth opportunities
Medical, dental, vision, life insurance, short- and long-term disability
Participate in the Company’s savings plan (401(k))
Eligible to participate in the Company’s 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
Company
Crescent Biopharma
Crescent Biopharma is a biotechnology firm focused on developing novel precision-engineered medicines.
11-50 employees
Funding
Current Stage
Public CompanyTotal Funding
$585MKey Investors
Fairmount Funds ManagementBiotechnology Value Fund,Fairmount Funds Management,Venrock Healthcare Capital Partners
2025-12-04Post Ipo Equity· $185M
2025-06-16Post Ipo Equity· $200M
2025-06-16IPO
Recent News
2026-01-06
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