Director Research & Development (R&D)

Cycle Pharmaceuticals; Cambridge; Hybrid; GBP 120,000 - 160,000; Full time

Benefits offered by this job

Hybrid working

Flexible core hours 10am–4pm

Performance-based bonus

Private Health Insurance

Company pension scheme

Life and Critical Illness Insurance

Job summary

Cycle Pharma, headquartered in Cambridge, UK, is seeking a Director of Research & Development to own late-stage programmes focused on rare metabolic and genetic diseases. Hybrid role with a minimum of three days in the office, reporting to the Chief Strategy Officer, with end-to-end responsibility from strategy through regulatory submission and FDA interactions.

You will lead an integrated R&D function across Product Development, Clinical Operations and Regulatory Strategy, mentor teams, manage

Qualifications

• Advanced degree required (PhD / MD / PharmD or equivalent).
• Deep expertise in Clinical Operations and study oversight.
• Ability to integrate Clinical Operations, Translational Medicine, Regulatory Strategy and Product Development into development plans.
• Experience in rare diseases/metabolic/genetic conditions.
• Strong regulatory acumen with US FDA readiness.
• Proven leadership of cross-functional teams and external partners.
• Strategic thinker with operational discipline and sound judgment.

Responsibilities

• Provide strategic and operational leadership for the product portfolio from development through regulatory submission and approval.
• Develop integrated development strategies aligning clinical, regulatory, translational and product activities with FDA pathways.
• Lead pivotal clinical development programmes with timelines, budgets, quality, and regulatory compliance.
• Oversee regulatory strategy and submission readiness across functions to support agency interactions.
• Ensure translational science, biomarkers, and nonclinical data strengthen programme outcomes.
• Provide executive oversight of CROs and external partners with governance and performance management.
• Collaborate with CMC, Quality, Regulatory Affairs, and Supply Chain to align activities.
• Build and develop a high-performing R&D organisation with scalable processes.
• Manage R&D budgets, resources, and priorities to maximise portfolio value.

Skills

Clinical Operations

Translational Medicine

Regulatory Strategy

Product Development

Rare Diseases

FDA/Regulatory Knowledge

Cross-Functional Leadership

Vendor Management

Education

PhD / MD / PharmD or equivalent

Job description

Position Summary:

This full-time position working in our Cambridge office on a hybrid basis (minimum 3 days in the office) reporting to the Chief Strategy Officer.

We are looking for an accomplished and strategic Director of Research & Development to take full ownership of the development and delivery of our late-stage programmes, with a particular focus on advancing innovative therapies for patients living with rare metabolic and genetic diseases.

This is a high-impact leadership role with end-to-end responsibility for late-stage development programmes from, defining development strategy through to execution and regulatory submission with the ultimate goal of supporting successful FDA approval and bringing much-needed treatments to patients. You will have strong managerial skills to support, mentor and develop an integrated R&D function spanning across Product Development, Clinical Operations and Regulatory Strategy, fostering strong cross-functional collaboration, clear accountability and a culture of high-quality execution.

Our product portfolio includes a number of new exciting programmes across rare genetic and metabolic conditions, including galactosemia, SORD, PMM2-CDG, HT-1 and PKU, alongside Cycle Pharma’s existing and evolving product portfolio.

Our Company

At Cycle Pharma, 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 core focus areas include oncology, rare metabolic, immunological and neurological 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 below and look at some of our patient stories: Patient Stories - Cycle Pharma

What You Will Be Doing:

• Provide strategic and operational leadership for the product portfolio, with overall accountability for the successful design, execution and delivery of development programmes through regulatory submission and approval.
• Develop and execute integrated development strategies that align clinical, regulatory, translational and product development activities with FDA approval pathways.
• Lead pivotal clinical development programmes, ensuring delivery against timelines, budgets, quality standards and regulatory requirements.
• Oversee regulatory strategy and submission readiness, driving alignment across clinical, nonclinical and product development functions to support successful agency interactions and approvals.
• Ensure translational science, biomarker strategies and supporting nonclinical data are effectively incorporated into development plans to strengthen programme outcomes and regulatory positioning.
• Provide executive oversight of external partners, including CROs and strategic vendors, ensuring effective governance, performance management, and inspection readiness.
• Partner closely with CMC, Quality, Regulatory Affairs, and Supply Chain teams to ensure development activities are aligned with programme objectives and regulatory timelines.
• Build, lead, and develop a high-performing R&D organisation, establishing scalable processes, governance frameworks, and ways of working that support portfolio growth and operational excellence.
• Manage R&D budgets, resources, and priorities to maximise portfolio value and ensure efficient delivery of key development milestones.

Skills And Experience You Will Bring Into The Business:

• Advanced degree (PhD / MD / PharmD or equivalent).
• Deep expertise in Clinical Operations, including study planning, vendor oversight, execution management, quality, and risk mitigation across global or multi-site programmes.
• Demonstrated ability to integrate Clinical Operations, Translational Medicine, Regulatory Strategy, and Product Development into coherent development plans.
• Experience in rare disease, ideally metabolic disorders (galactosemia, PKU, HT-1, CDG, or similar).
• Strong understanding of regulatory pathways and development requirements in the US, including FDA expectations, GCP standards, and readiness for key regulatory interactions.
• Experience working closely with CROs, external scientific partners, and other outsourced development providers, with clear accountability for performance, quality, and delivery.
• Proven ability to lead cross-functional teams, influence senior stakeholders, and drive progress in a lean and evolving organisational environment.
• Able to combine scientific credibility, operational discipline, and sound judgement to support high-quality decision-making across a growing portfolio.

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
• Flexible core working hours of 10am – 4pm and hybrid working
• 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
• 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.