Senior Nonclinical Development Lead (Hybrid)

Cycle Pharmaceuticals; Cambridge; Hybrid; GBP 90,000 - 130,000; Full time

Benefits offered by this job

Competitive salary

Bonus

Pension scheme

Private health insurance

Team events

Job summary

Cycle Pharmaceuticals is expanding its Research and Development team in Cambridge and seeks a Senior Nonclinical Development Manager to lead nonclinical and translational science across a diverse portfolio.

You will own study design, CRO oversight, and regulatory-aligned strategies spanning pharmacology, toxicology, and translational science to inform clinical development and patient outcomes.

Qualifications

• PhD or equivalent in a life sciences discipline.
• Significant pharma/CRO experience designing and overseeing non-clinical in vivo studies, including GLP toxicology.
• Experience managing non-clinical CROs, including protocol and report review.
• Strong knowledge of GLP and regulatory guidance (ICH M3(R2), S-series) and FDA expectations for IND-enabling packages.
• Experience translating nonclinical findings into clinical starting doses and safety margins.
• Experience authoring non-clinical sections of regulatory submissions (Investigator’s Brochures, CTD Module 2.4/2.6).
• Desirable: experience with rare disease models; 505(b)(2) programmes; DABT/ERT certification.
• Strong scientific judgement and communication skills across disciplines.

Responsibilities

• Lead design, placement, oversight and interpretation of nonclinical studies (pharmacology, PK/TK, ADME, GLP/non-GLP toxicology).
• Develop integrated nonclinical development plans aligned with clinical/regulatory strategies.
• Select and manage nonclinical CROs and laboratories; oversee protocols, data, timelines and budgets.
• Ensure GLP compliance and 3Rs animal welfare standards.
• Interpret findings to inform clinical development, including NOAELs and starting doses.
• Define translational hypotheses and biomarker strategies.
• Review nonclinical content for regulatory submissions and interactions.
• Collaborate with cross-functional teams to support programme progression.
• Evaluate investigator-initiated research and collaborations within governance frameworks.
• Contribute to budgeting and process improvements.

Skills

Nonclinical study design

CRO management

GLP toxicology

Regulatory guidance

IND submissions

Education

PhD in pharmacology/toxicology/physiology

Job description

Cycle Pharmaceuticals is expanding its Research and Development team in Cambridge and seeks a Senior Nonclinical Development Manager to lead nonclinical and translational science across a diverse portfolio.

You will own study design, CRO oversight, and regulatory-aligned strategies spanning pharmacology, toxicology, and translational science to inform clinical development and patient outcomes.