Cycle Pharmaceuticals is seeking a Senior Clinical Study Manager to lead the operational delivery of Phase 3 trials and Phase 4 post-approval studies across rare diseases from feasibility to final report. The role reports to the Associate Director of Clinical Operations and requires oversight of timelines, budgets, quality and regulatory compliance.

You will own studies, coordinate site selection, supply planning, and DMC activities while collaborating with cross-functional teams.

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).

At Cycle Pharma, we're looking for an experienced medical writer to lead the development of clinical and regulatory documents across our late-stage and post-approval programmes, helping bring important treatments to patients with rare and complex diseases.

You'll take ownership of key documents across the clinical development journey, from Phase 3 study protocols and clinical study reports through to marketing applications, as well as Phase 4 and post-approval studies supporting our marketed products. Combining hands-on authoring with oversight of external writing partners, you'll play a pivotal role in ensuring our submissions are scientifically robust, clearly communicated and consistently delivered to the highest standards.

Working across programmes in metabolic disease, neurology, immunology and oncology, you'll collaborate closely with Clinical Development, Regulatory Affairs, Clinical Operations, Pharmacovigilance and Medical Affairs. You'll bring complex clinical data and regulatory requirements together into clear, accurate and compelling documents that support sound decision-making and successful regulatory submissions.

If you're a detail-oriented medical writer who combines scientific expertise with excellent communication skills, enjoys collaborating across multidisciplinary teams and wants to make a meaningful contribution to the development of treatments for patients with significant unmet medical needs, 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 & 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 authoring of pivotal Phase 3 clinical documents, including protocols, amendments, informed consent forms, Investigator's Brochure updates and final clinical study reports.
• Own the preparation of clinical content for FDA meetings and marketing applications, including briefing packages, responses to regulatory questions, CTD Module 2.5 and 2.7 summaries, and integrated summaries of efficacy and safety.
• Collaborate with Clinical Operations and CRO's to ensure data support is clear, accurate and consistent.
• Lead the authoring of protocols and reports for Phase 4 and post-approval studies, including post-marketing requirement and commitment studies, open-label extensions, registries and observational studies.
• Prepare clinical content for post-approval submissions, labelling supplements, annual reports and post-marketing study reports, and support Pharmacovigilance with periodic safety reports where required.
• Prepare data monitoring and steering committee materials, patient-facing study information and plain language summaries, and contribute to manuscripts and congress materials in collaboration with relevant teams.
• Lead clinical trial registration and results disclosure on ClinicalTrials.gov, ensuring consistency of data and key messages across protocols, reports, submissions and publications, while maintaining appropriate separation from promotional activities.
• Collaborate with Regulatory to establish and maintain writing standards, templates, style guides and quality control processes aligned with relevant regulatory guidance, including ICH E3 and M11, ensuring documents are accurate, inspection-ready and appropriately archived.
• Oversee document planning, timelines, review cycles and comment resolution, while forecasting medical writing resource needs and selecting and managing external writing providers.
• Contribute to departmental budgeting, operational planning and prioritisation; maintain awareness of evolving regulatory and industry guidance; drive process improvements; and support the development of future direct reports and contract writers.

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

• Degree in life sciences or a related discipline, PhD or other advanced degree preferred.
• Extensive experience in clinical and regulatory medical writing within the pharmaceutical, biotechnology or CRO industry, with lead authorship of Phase 3 protocols and clinical study reports.
• Experience authoring clinical documents for an NDA, BLA or MAA, including CTD Module 2 clinical summaries and integrated summaries (strongly preferred).
• Experience writing protocols and reports for post-approval studies, such as post-marketing requirement studies, open-label extensions, registries or observational studies.
• Experience with clinical trial disclosure requirements, including ClinicalTrials.gov results posting is desirable.
• Strong working knowledge of ICH guidelines (including E3, E6, E9 and M4), FDA expectations and eCTD structure.
• Ability to interpret and present clinical and statistical data accurately.
• Experience managing outsourced writing providers or freelance writers.
• Membership or certification with EMWA or AMWA (desirable); experience with document management systems such as Veeva Vault (desirable).
• Excellent attention to detail, project management and stakeholder management skills, with 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
• 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.

Medical Associate Director - Clinical Development

Cambridge

Medical Associate Director - Clinical Development

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).

At Cycle Pharma, we're recruiting for a Medical Associate Director - Clinical Development to join the team and provide medical leadership across our late-stage development programmes, shaping the clinical strategy and delivery of Phase 2 and Phase 3 studies in rare diseases.

Acting as the sponsor's medical lead for assigned programmes, you'll bring together rare disease expertise, clinical pharmacology, translational science and regulatory insight to design robust, patient-focused clinical development strategies - from early planning through to regulatory submission.

With a primary focus on rare metabolic diseases and opportunities to contribute across our wider neurology, immunology and oncology portfolio, you'll tackle the scientific and clinical challenges of developing treatments for small, patient populations. You'll play a key role in translating complex data and evolving regulatory requirements into meaningful clinical decisions and programmes designed to deliver clear, relevant evidence.

This is an opportunity for a physician with strong scientific depth, sound clinical judgement and a passion for drug development to take broad ownership, influence critical programme decisions and help shape clinical development within a growing organisation.

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 & 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 clinical development strategy for assigned programmes, translating target product profiles into integrated development plans and defining clinically meaningful, feasible study objectives, populations and endpoints for rare disease populations.
• Work closely with Regulatory Affairs on clinical and regulatory strategy, including endpoints, natural history data and external control approaches; act as clinical lead in FDA meetings and author or review clinical content for regulatory submissions and briefing packages.
• Own the medical and scientific content of clinical protocols, amendments, statistical analysis plan inputs and informed consent materials, integrating nonclinical and translational evidence into dose selection and patient eligibility decisions.
• Lead scientific engagement with investigators, clinical experts, advisory boards and steering committees, and oversee clinical outcome assessment and patient-reported outcome strategies in collaboration with external experts and patient advocacy groups.
• Lead clinical pharmacology across assigned programmes, including dose and regimen selection, exposure-response analysis, dose justification for pivotal studies, and paediatric dose selection and extrapolation.
• Design and interpret clinical pharmacology studies, including bioavailability, bioequivalence, food effect, drug-drug interaction and special population studies; oversee population PK, PK/PD and physiologically based modelling, and define bridging strategies for reformulation programmes.
• Act as sponsor medical lead for assigned studies, overseeing CRO medical monitors, responding to medical queries and reviewing clinical data for eligibility, medically significant protocol deviations, and emerging safety and efficacy trends.
• Partner with Pharmacovigilance on serious adverse events, safety signal evaluation and reporting; support data monitoring committees.
• Contribute to publications and congress presentations, maintain awareness of evolving FDA, EMA and ICH guidance, and drive the development and implementation of clinical development procedures and standards.
• Contribute to departmental budgeting, resource planning and prioritisation.

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

• Medical degree (MBBS, MBChB or equivalent) with full GMC registration, or eligibility for registration.
• Clinical training in a relevant specialty, such as metabolic medicine, paediatrics, neurology or clinical pharmacology is desirable.
• Significant pharmaceutical or biotechnology industry experience in clinical development, including medical monitoring or medical leadership of Phase 2 and/or Phase 3 studies.
• Experience in clinical pharmacology, including dose selection, PK/PD interpretation and the design of clinical pharmacology studies (strongly preferred).
• Experience in rare disease clinical development.
• Direct experience of FDA interactions, such as Type B or end-of-Phase 2 meetings.
• Experience designing studies in small populations, including novel endpoints, natural history comparisons or adaptive designs.
• Sound knowledge of ICH-GCP and relevant ICH guidelines, including E4, E6, E8, E9 and E11.
• Strong scientific and clinical judgement, with the ability to make decisions in areas of uncertainty and communicate them clearly to technical and non-technical audiences.
• Excellent written and verbal communication skills, with the ability to influence across disciplines without direct authority.
• Willingness to travel, including to the US.

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
• 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.

Cycle Pharmaceuticals is seeking an experienced medical writer to lead the development of clinical and regulatory documents across late-stage and post-approval programmes. You will own key documents from Phase 3 through to marketing applications, while coordinating with external writers to ensure robust and compliant submissions.

You will collaborate across Clinical Development, Regulatory Affairs, and Medical Affairs, integrating complex clinical data to support regulatory submissions and sound

Cycle Pharmaceuticals in Cambridge is seeking a Medical Associate Director - Clinical Development to provide medical leadership across late-stage programmes, shaping clinical strategy and trial delivery for Phase 2 and 3 studies in rare diseases.

You will act as sponsor medical lead, integrating clinical pharmacology and translational science, and drive regulatory submissions while collaborating with cross-functional teams across global trials.

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).

Do you want to make a meaningful difference in rare disease research?

At Cycle Pharmaceuticals, we're expanding our Research and Development team and now recruiting for a hands-on Senior Clinical Study Manager to manage the operational delivery of Phase 3 clinical trials and Phase 4 post-approval studies across rare diseases, including studies undertaken to meet FDA post-marketing requirements and commitments.

Reporting to the Associate Director of Clinical Operations, you'll take ownership of assigned studies from feasibility through to final clinical study report, ensuring delivery to agreed timelines, budgets and the highest standards of quality and regulatory compliance.

This is an opportunity to take on broad responsibility in a growing organisation, combining independent ownership, cross-functional collaboration and the opportunity to help advance research in rare diseases.

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 & 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:

• Delivery of assigned Phase 3 clinical studies from feasibility through to database lock and final clinical study report, managing timelines, budgets, risks and quality.
• Lead feasibility, country and site selection and develop recruitment and retention strategies tailored to small and pediatric populations, including patient-centric and decentralised approaches where appropriate.
• Coordinate clinical supply planning, randomisation, interim analyses, data monitoring committee activities and adaptive design decision points in collaboration with relevant teams.
• Support with operational delivery of post-approval studies, including FDA post-marketing requirements and commitments, registries, observational studies, real-world evidence and open-label extensions, ensuring key regulatory milestones are met.
• Support partner selection and contracting and vendor performance, monitor KPIs and study expenditure.
• Ensure studies comply with applicable GCP and regulatory requirements, oversee regulatory and ethics submissions, maintain the electronic Trial Master File (eTMF), and support audits, inspections and CAPA follow-up.
• Build effective relationships with investigators, specialist centres and patient advocacy groups.
• Proactively identify and mitigate operational risks and issues, escalating significant concerns and implementing appropriate corrective actions.
• Contribute to departmental budget planning, resource forecasting and prioritisation to support clinical operations strategy and efficient study delivery.
• Improve clinical operations processes and procedures, share best practice, and mentor and support clinical operations colleagues, with potential for future line management responsibilities.

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

• Degree in life sciences, pharmacy or a related discipline required; an advanced degree is preferred.
• Significant clinical operations experience within the pharmaceutical, biotechnology or CRO industry, including operational leadership of Phase 3 clinical studies.
• Experience delivering studies in rare diseases, metabolic conditions or paediatric populations is strongly preferred.
• Experience managing post-approval studies, including FDA post-marketing requirement and commitment studies, open-label extensions, registries or observational studies, is strongly preferred.
• Strong experience working with US clinical sites and FDA requirements and familiarity with FDA Bioresearch Monitoring inspections is an advantage.
• Proven ability to oversee CROs and vendors, manage study budgets and maintain high-quality electronic Trial Master Files (eTMFs).
• Experience with hybrid or decentralised trial approaches, including home nursing and direct-to-patient supply, is desirable.
• Strong working knowledge of ICH-GCP, including E6(R3), and applicable FDA, MHRA and EMA requirements.
• Excellent organisational, analytical and project management skills, with the ability to manage competing priorities, solve problems independently and drive delivery.
• Strong communication and stakeholder management skills, with the confidence to work effectively across cross-functional teams and external partners.
• Proactive, hands-on and decisive, with a practical, solutions-focused mindset and a willingness to travel, including internationally to the US.

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
• 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.