Medical Associate Director – Clinical Development

Cycle Pharmaceuticals; Town of Cambridge; Hybrid; AUD 208,000 - 303,000; Full time

Benefits offered by this job

Competitive salary

Collaborative environment

Performance bonus

Growing business

Pension scheme

Private Health Insurance

Life Insurance

Team events

Job summary

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.

Qualifications

• Medical degree with GMC registration or eligibility.
• Clinical training in metabolic medicine, paediatrics, neurology or pharmacology desirable.
• Significant pharma/biotech clinical development experience.
• Experience in clinical pharmacology, dose selection and PK/PD.
• Rare disease clinical development experience.
• Direct FDA interactions experience.
• Studies in small populations with novel endpoints or adaptive designs.
• Strong knowledge of ICH-GCP and ECH guidelines (E4/E6/E8/E9/E11).
• Strong scientific and clinical judgement with clear communication.
• Excellent written and verbal communication skills; travel willingness.

Responsibilities

• Lead the clinical development strategy for assigned programmes, translating TPIs into integrated plans and endpoints.
• Collaborate with Regulatory Affairs on clinical/regulatory strategy; lead FDA interactions and regulatory submissions.
• Own medical content of protocols, amendments, SAP inputs and consent materials.
• Lead scientific engagement with investigators, advisory boards and steering committees.
• Oversee clinical pharmacology including dose justification for pivotal studies and paediatric dosing considerations.
• Design and interpret clinical pharmacology studies and PK/PD modelling; bridging for reformulation.
• Act as sponsor medical lead for studies, oversee CRO medical monitors and safety trends.
• Partner with Pharmacovigilance on SAE evaluation and safety signals.
• Contribute to publications, congress presentations and evolving clinical development standards.
• Contribute to budgeting, resource planning and prioritisation.

Skills

Medical leadership

Regulatory strategy

Clinical pharmacology

Excellent communication

Willingness to travel

Strategic thinking

Education

MBBS / MBChB or equivalent

Full GMC registration or eligible

Clinical training in metabolic medicine / paediatrics / neurology / pharmacology

Job description

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 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 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.