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Senior Clinical Trial Associate
2 months ago
Bicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. The company is evaluating BT8009, a Bicycle® Toxin Conjugate (BTC®) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BTC targeting EphA2, a historically undruggable target; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist® (Bicycle TICA®) targeting Nectin-4 and agonizing CD137, in company-sponsored clinical trials. Additionally, the company is developing Bicycle® Radio Conjugates (BRC™) for radiopharmaceutical use and, through various partnerships, is exploring the use of Bicycle® technology to develop therapies for diseases beyond oncology.
Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, MA.
Culture is key and all Bicycle employees actively embrace and role model our company values:
- We are Adventurous . We believe it’s the way to deliver extraordinary results for our patients.
- We are Dedicated to our Mission . You can’t change the world if you don’t have determination.
- We are One Team . We only succeed when we work together.
We are looking for a Senior Clinical Trial Associate that will be responsible for administering, coordinating, and maintaining the logistical aspects of Bicycle’s clinical study programs. In this role, they will be responsible for communicating effectively with internal and external study personnel and in facilitating the activities associated with the successful clinical trial management and execution of Bicycle’s clinical programs.
The position will be a member of the Clinical Operations group, reporting to the Associate Director, Clinical Operations.
Key responsibilities:
- Support the clinical study team(s) with the oversight of CROs and management of studies, including planning, execution, and close-out of clinical trials
- Assists with management of study-related vendors
- Assist the Clinical Trial Manager (CTM) in preparing Protocols, Informed Consent Forms, Investigator Brochures and other study documents, and track revisions
- Support the CTMs in the set up and maintenance of the internal electronic filing systems (eTMF) compliant with regulations and in audit ready state, as well as general study filing
- Ensure that tracking tools are developed and maintained throughout the trials for the Clinical Operations teams
- Perform lab sample tracking, utilizing the central lab database
- Perform drug supply tracking and management
- Review of data management aspects of clinical trials
- Support clinical operations functions during audits (e.g. BIMO, FDA)
- Participate in the review and approval of clinical monitoring visit reports in conjunction with the CTM and track outstanding follow-up items as requested
- Participate in the review and finalization of study plans and circulate for approval
- Day-to-day contact with counterpart at CRO; daily review and identification of potential issues or problems with the sites and communicate/escalate to CTM or senior Clinical Operations staff
- Perform QC of electronic Trial Master Files
- Fully understand the need for and importance of being inspection ready and diligently follow Clinical Operations SOPs; identify and communicate any gaps
- Accountable for ensuring that agendas for meetings are clear and distributed in advance; take comprehensive and precise minutes for internal and external meetings
- Assist CRO with planning of Investigator Meetings and associated travel
- Under the guidance and direction of the CTM, interface with other internal functions to coordinate relevant and timely exchange of information/materials to support clinical trials
- Support invoice and budget activities for clinical trials
- Facilitate review of clinical trial agreements such as contracts and licenses
- Identifies potential risks from study and site perspective and works with the CTM to assist in proactively resolving issues with CROs
- Participates in UAT for EDC/IRT
Essential:
- Bachelor’s degree in scientific, biological, life sciences, or related field
- Familiarity with ICG, GCP, and FDA requirements, as applicable, for clinical trial management
- Strong organizational skills and enjoys working in a methodical way
- Strong analytical and problem-solving skills
- Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment
- Attention to detail and quality
- Excellent written and oral communication skills
- Proficiency with Microsoft Office (Excel, Word, Outlook, PowerPoint, SharePoint)
- Flexible approach to change
Desirable:
- Early phase and/or Oncology experience
- State-of-the-art campus environment with on campus restaurant and Montessori nursery
- Flexible working environment
- Competitive reward including annual company bonus
- Employee recognition schemes
- 28 days annual leave in addition to bank holidays + option to buy up to 5 additional days annually
- Employer contribution to pension (employee does not have to contribute)
- Life assurance cover 4x basic salary
- Private Medical Insurance, including optical and dental cover
- Enhanced parental leave policies
- Group income protection
- Employee assistance program
- Health Cash Plan
- Access to company subsidized gym membership
- Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.
- Cycle to work scheme
Bicycle Therapeutics is committed to building a diverse workforce that is representative of the communities we serve. We recognize that diverse and inclusive teams build a stronger and more innovative company. Therefore, all qualified applicants will be considered for employment, and we do not discriminate on the basis of race, religion, colour, gender, sexual orientation, age, disability status, marital status, or veteran status.
