Medical Director

Medical Director 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). 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 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 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