Clinical Development Associate (Cambridge, UK)
The Opportunity
Cycle Pharmaceuticals is looking for an enthusiastic and talented team player to join its growing Regulatory Affairs department as a Clinical Development Associate.
The Clinical Development Associate will play a crucial role in supporting pre-clinical and clinical activities. As a key contributor, you will be involved in vendor selection, study design and planning, document review, study data evaluation, and project management. Your scientific knowledge will be instrumental in feasibility assessments and product development.
This exciting position offers the chance to work across various therapeutic areas, including metabolic, immunology, neurology, and oncology, and to explore different technologies and dosage forms. You’ll build your internal network, contribute to cross-functional project teams, and participate in diverse company projects, making a tangible impact on our growth and the patients we support.
You will collaborate with departments such as Product Development, Quality, Supply Chain, Legal, Regulatory, and Compliance, and engage with third-party contract and partner organizations.
The Cambridge team is relatively small but highly dynamic, requiring an adaptive and pragmatic mindset. Coaching and mentoring to support continuous learning and professional development will be provided and tailored to individual needs.
Job Title: Clinical Development Associate
Cycle Company: Cycle Pharmaceuticals Ltd
Position Summary: This is a full-time position within the Regulatory Affairs department, working in our Cambridge office.
What you will be doing
Key Responsibilities
Technical responsibilities:
• Manage preclinical and clinical studies with support from Clinical Development Manager/Early Asset Development Lead.
• Provide input into the strategies for early pipeline products in line with Cycle’s vision.
• Manage relationships with third party vendors.
• Support the review of documents, including study protocols, reports and regulatory submissions.
General responsibilities
• Contribute to the successful project management of all assigned projects including budget management, vendor relationship management, issue and risk identification and management.
• Contribute to compliance with ICH GCP, any applicable regulations and Standard Operating Procedures (SOPs).
• Contribute to the maintenance of any relevant SOPs i.e. reviewing SOPs, in relation to pre-clinical studies, GLP, GCP, CRO oversight and Clinical Study Management.
Departmental responsibilities:
• Attend team meetings and engage with internal and external stakeholders providing support and subject leadership as required.
• Maintain knowledge of relevant guidance (in particular US-FDA and UK-MHRA focused) and provide advice on key requirements for development activities.
• Act as a key contact with third party external partners.
• Contribute to the development and improvement of the procedures and processes used by the department, identifying problem areas, proposing and implementing robust solutions in order to improve efficiency and consistency.
Qualifications and Skills
Essential
• Bachelor’s degree in a health related/life sciences field.
• Good understanding of product development processes and global pre-clinical and/or clinical trial regulations from academia or industry experience.
• Excellent written and oral communication
• Ability to work in a proactive and autonomous manner, as well as being part of a team.
• Good time management skills with a high level of attention to detail.
• Ability to create and maintain strong working relationships across the organisation and with external partners.
• Self-motivated, enthusiastic and hard-working.
• Strong analytical, organisational and problem-solving skills.
• Quality focused.
Desirable
• Advanced degree in a health related/life sciences field.
• Awareness of clinical trial operations, from start up to close, across all phases.
• Experience in CRO oversight/management in a small/medium size pharmaceutical company.
• Prior experience in project management/pre-clinical/clinical study management in a pharmaceutical research industry.
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
Applications
Cycle Pharmaceuticals embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
Please send your application and cover letter to:
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