Clinical Contracts and Outsourcing Associate

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

Reporting to the Head of Clinical Outsourcing and Business Operations, the Clinical Contracts and Outsourcing Associate will be responsible for supporting various activities and projects within the vendor outsourcing department. In addition, the Associate will be responsible for supporting the clinical contracting needs of the development and translational medicine organization. As the Clinical Contracts and Outsourcing Associate, you will work in close collaboration with vendors, the Clinical Operations and Legal Teams to streamline the contracting process. In addition, you will provide support to clinical development under the supervision of the Head of Clinical Outsourcing and Business Operations by helping support vendor selection and contracting activities as assigned.

In this cross functional role, you will be a member of the Clinical Operations group and will work closely with members of Clinical Operations, Clinical Development, Translational Medicine, Finance, and Legal teams.

The Clinical Contracts and Outsourcing Associate will be responsible for supporting various activities and projects within the Vendor Outsourcing and Clinical Contracts Department

Supporting the contract lifecycle management for following types of contracts:

• Confidentiality Agreements (CDAs)
• Letters of Authorization (LOAs) to authorize work with Contract Research Organizations (CROs)
• Clinical Consulting Agreements
• Scientific Collaboration Agreements
• Third party laboratory contracts
• Other contracts as identified, as needed

Working with development and translational medicine functions to support contract processes including submission of purchase orders, routing of contract signature, review of contract terms. QC (Quality Control) of contractual documents before entry into contract approval process.

Manage the contract approval process and Purchase order updates for all contracts that are needed for both development operations and translational medicine.

Scheduling meetings with key stakeholders to support the development of RFPs (Request for Proposals), development roundtables, bid defenses, etc.

Providing timely and accurate tracking, management and filing of contacts within company systems

• Providing excellent customer service to internal stakeholders to support the execution of timely and high-quality contracts
• Partnering with business compliance, legal, finance and other internal stakeholders to ensure proper facilitation and execution of contract

Qualifications

Essential:

• Motivated self-starter who is capable of flourishing in a fast-paced small company environment
• Is structured, well organized, attentive to detail and process oriented
• Has strong interpersonal skills including good written and verbal communication skills
• Complies with required processes in a regulated environment
• Comfortable interacting external stakeholders (vendors, laboratories, healthcare professionals)
• Experience in contracts, legal agreements, and financial budgeting preferred
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