Cycle Pharma

Cambridge, UK • Posted on 11th Jul 2024

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, and the work environment is representative of an expanding company, hence requiring an adaptive and pragmatic mindset. Coaching and mentoring to support continuous learning and professional development will be provided and tailored to individual needs.

 

Our Company

 

At Cycle, we believe that Every Single Patient Matters, this is at the heart of why we work, and we’d love for you to 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.

 

We are a pioneering pharmaceutical company, reimagining how drugs and services can benefit patients with rare disease to make their lives easier and improve their quality of life. Cycle, as a company, works closely with patient groups and healthcare professionals to understand the unmet needs of patients and their carers. By collaborating with academic communities and using the latest cutting-edge pharmaceutical technologies, we translate innovations into medicinal products that patients and caregivers actually desire. We deliver the required medicine with the minimum impact on daily routines and, just as importantly, provide individualized support services to patients, families, carers and the healthcare professionals community.

 

Cycle has three core areas of pharmaceutical development and work across rare metabolic, immunological and neurological genetic conditions: improving drugs – optimizing an existing drug; repurposing drugs – creating a new indication for an existing drug; and generics – reinstating generic drugs, previously available in the market. These three areas of focus are underpinned by formulation technology – using new drug delivery technologies to improve the efficacy and effectiveness of drugs, allowing us to give patients greater freedom and choice.

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: