Company Description

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.

Job Description

We are looking for a Study Start Up Associate that will be responsible for supporting the successful execution of global start-up, maintenance, and close-out.

The position will be a member of the Clinical Operations group, reporting to the Associate Director, Clinical Operations.

• Responsible for performing country and site feasibility, site identification, site contract negotiation, and other study start up (SSU) activities independently or in partnership with internal stakeholders and external CRO partner.
• Contribute to study vendor selection and onboarding
• Support negotiation and execution of Investigator/ Institution contracts
• Contribute to project meetings including internal meetings and CRO/ vendor meetings
• Develop, review, and finalize study start up materials including Master and Country Specific Informed Consent Forms and participant materials.
• Responsible for the quality oversight of the preparation and coordination of initial and ongoing submissions to IRBs/ECs including timely follow up for IRB/EC queries.
• Responsible for the collection and maintenance of the current IRB/EC submission information
• Support the coordination and preparation of submissions to Regulatory Agencies (RA) and/or Competent Authorities (CA)
• Responsible for the collection and maintenance of the current RA/CA submission information.
• Assist with the timely follow-up to questions raised by RA/CA.
• Responsible for the timely and accurate tracking of all global SSU activities and providing updates on start up status, KPIs and metrics to internal stakeholders and leadership
• Responsible for TMF inspection readiness for SSU documents
• Participate in the development of WIs and SOPs associated with study startup activities

Qualifications

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

Additional Information

• Flexible working environment
• Competitive reward including annual company bonus
• Medical, dental, and vision insurance for eligible employees and their families with 100% of the premiums covered by the Company
• Health and Dependent Care Flexible Spending Accounts
• 401(k) plan with a 4% Company match and immediate vesting
• Eligibility to accrue up to 23 paid time off days per full year worked, plus the option to buy up to 5 additional days
• Employee assistance program
• Employee recognition schemes
• 10 Company holidays
• Competitive Family Leave Policy
• Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.

All your information will be kept confidential according to EEO guidelines.

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.