Senior Nonclinical Development Manager

Senior Nonclinical Development Manager

Cycle Company: Cycle Pharmaceuticals Ltd

Position Summary: This full-time position is within the Research and Development department in our Cambridge office on a hybrid basis (minimum 3 days in the office).

We’re expanding our Research and Development team and recruiting for a Senior Nonclinical Development Manager to lead nonclinical and translational science across our development portfolio, helping turn promising science into robust development strategies for patients living with rare and complex diseases.

In this role, you’ll take ownership of nonclinical study design, oversight and interpretation, spanning pharmacology, disease models and GLP toxicology. Working across programmes in metabolic disease, neurology, immunology and oncology. You’ll ensure nonclinical development packages are scientifically rigorous, strategically aligned and designed to meet FDA expectations.

From new molecular entities to reformulation programmes under the 505(b)(2) regulatory pathway, you’ll work closely with both internal teams and external experts to generate meaningful evidence, manage specialist CROs and bioanalytical partners, and translate study findings into clear recommendations that inform clinical development.

If you’re a nonclinical scientist who thrives on solving complex scientific challenges, brings strong study design and CRO management experience, and wants to see the impact of your work across the development journey, we’d love to hear from you.

Our Company

At Cycle, we believe that Every Single Patient Matters. This is at the heart of why we work and were looking for people to join our team who share our vision. We know that life-changing treatments need life-improving product support to match, because when you put the two together, great things can happen.

Our growing portfolio now covers oncology, haematology, neurology and rare metabolic genetic conditions where we improve existing drugs, repurpose them for new uses and bring generics back to market. Using cutting-edge drug delivery technologies, we enhance the efficiency of treatments, offering patients greater freedom and choice.

Headquartered in Cambridge, UK, with a significant US presence, Cycle has scaled rapidly and was named one of the UK’s fastest-growing private companies by The Sunday Times (Sunday Times 100 2024 & Sunday Times 100 Tech 2025). If you want to know more about what we do then, why not check out our website and take a look at some of our patient stories: Patient Stories - Cycle Pharma

What you’ll be doing in this role:

• Lead the design, placement, oversight and interpretation of pharmacology, proof-of-concept, PK/TK, ADME and GLP/non-GLP toxicology studies, including safety pharmacology, genotoxicity, reproductive toxicology and juvenile animal studies.
• Develop integrated nonclinical development plans aligned with clinical and regulatory strategies, identifying data gaps and defining study requirements in collaboration with Regulatory Affairs, including bridging strategies for reformulation programmes.
• Select and manage nonclinical CROs, bioanalytical laboratories and consultant toxicologists, overseeing study protocols, interim data, reports, timelines, budgets and issue resolution; act as sponsor representative for GLP studies where required.
• Ensure studies meet applicable GLP requirements, relevant ICH guidelines and regulatory expectations, while upholding high standards of animal welfare and the principles of Replacement, Reduction and Refinement (3Rs).
• Interpret nonclinical findings to inform clinical development, including NOAELs, safety margins, exposure limits, starting doses and dose escalation, working closely with Clinical Development.
• Define translational hypotheses and biomarker strategies that connect mechanism of action and nonclinical findings to anticipated clinical outcomes, informing clinical protocols, safety monitoring plans and target product profiles.
• Review nonclinical content for Investigator’s Brochures, IND submissions, FDA meeting briefing packages and CTD Module 2 summaries and overviews, supporting regulatory interactions and maintaining awareness of evolving FDA, EMA and ICH guidance.
• Collaborate with Product Development (CMC) to coordinate test article supply and formulation, and work across Clinical Development, Regulatory Affairs, Quality, Clinical Operations and Pharmacovigilance to support programme progression.
• Evaluate nonclinical aspects of investigator-initiated research and academic collaborations within established governance frameworks, engaging with academic collaborators and key opinion leaders to inform disease model selection and translational priorities.
• Contribute to departmental budgeting, resource planning and prioritisation, drive improvements in nonclinical procedures and CRO oversight processes.

The following skills and experience will be important in helping to set you up to succeed in this role:

• PhD in pharmacology, toxicology, physiology or a related life science discipline.
• Significant pharmaceutical, biotechnology or CRO experience designing, placing and monitoring non-clinical in vivo studies, including GLP toxicology.
• Demonstrated experience managing non-clinical CROs, including protocol and report review and resolution of study issues.
• Strong working knowledge of GLP and non-clinical regulatory guidance, including ICH M3(R2), S-series guidelines and FDA expectations for IND-enabling and marketing application packages.
• Experience translating non-clinical findings into clinical starting doses and safety margins.
• Experience authoring non-clinical sections of regulatory submissions, including Investigator’s Brochures and CTD Module 2.4 and 2.6 (preferred).
• Experience with rare disease models, juvenile toxicology or 505(b)(2) programmes (desirable); toxicology certification such as DABT or ERT (desirable).
• Strong scientific judgement and analytical capability, with excellent written and verbal communication skills and the ability to influence across disciplines without direct authority.

What can we offer to you:

In addition to being part of a great team and doing things that will make a real difference to patients’ lives, you will enjoy all the benefits that brings:

• Competitive salary based on experience
• A collaborative high performing work environment
• Performance based bonus
• Opportunity to join a fast growing and ambitious business
• Company pension scheme
• 100% employer paid membership for Private Health Insurance
• Life and Critical Illness Insurance
• Corporate Gym membership
• Regular team building events and an agile working environment

Diversity and Inclusion statement:

At Cycle Pharmaceuticals, we are committed to creating an inclusive, respectful, positive and diverse workplace. We do not discriminate on the basis of race, colour, religion, gender, age, disability, or any other protected characteristic. We actively support and embrace diversity, and we are working to build a team that reflects a wide range of backgrounds and perspectives.

We value your unique contributions and encourage you to join us in shaping a more inclusive future. If you require any reasonable adjustments - whether during the application process or in the workplace - we will be happy to support your needs. At Cycle, equality, inclusion, and respect are at the core of everything we do. We fully comply with all applicable employment laws, including those related to non-discrimination, work authorization, and employment eligibility verification.