Manager, Clinical Outsourcing
3 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 Manager, Clinical Outsourcing. The right candidate will possess an understanding of Clinical Outsourcing activities for successful execution of multiple clinical trials primarily in oncology indications in various phases of development. In addition, this candidate will oversee the vendor selection and contracting processes with CROs, Central laboratory, Imaging, IRT and other suppliers as assigned. They will support the development building of the infrastructure of the Clinical Outsourcing group and provide overall subject matter expertise on outsourcing and contracting practices.
The position will be a member of the Clinical Operations group, reporting to the Director, Clinical Outsourcing and Business Operations.
- Manages the identification and selection process of clinical vendors such as CROs, central labs, imaging,
- Supports the creation and management of preferred provider relationships, functional service provider, negotiated rate cards, volume discounts, etc.
- Collaboratively creates and issues Request for Proposals (RFPs), compiles responses and facilitates team review of proposals from suppliers.
- Participates in pricing negotiations for CROs and other critical study vendors.
- Leads and facilitates cross functional review vendor selection meetings
- Manages work order amendments and change orders to ensure appropriate pricing and timely execution
- Facilitates and leads vendor governance meetings with key CRO and vendor partnerships.
- Collaborated with global clinical teams and preferred suppliers to analyze trends, assess performance, improve efficiencies, leverage resources, and reduce costs,
- Reviews metrics and Key Performance Indicators (KPIs) to ensure oversight of clinical trial progress and participates in quality review of vendor performance.
- Liaises with key functions including Clinical Operations, Finance, Legal, Biostatistics, PV, QA, Data Management, and Clinical Development to ensure appropriate stakeholder engagement in vendor selection and management.
- Work closely with finance to assure the assumptions for studies are aligned between finance and clinical forecasting.
- Collaborates with Clinical Operations, Global Project Management, Quality Assurance and IT, as well as other cross-functional teams as needed, to provide management support and guidance regarding the identification, selection and management of potential new business processes and systems (eg; CTMS, TMF, Grant Management) in Clinical Operations and Clinical Development as assigned
- Supports the development and maintaining RFP templates, Change Order and Change Notification Form trackers, Confidentiality Agreements (CDAs), Master Service Agreements (MSAs) and project-specific agreements as assigned.
- Ensures awareness of trends in the industry in the field of innovation in pharmaceutical clinical trials by scanning internal and external operational trends and evaluating new innovative platforms and practices
- Supports the development of the Clinical Outsourcing department infrastructure with assisting in developing process documents, input to SOPs, and provide training to others.
- Provide review of quarterly and monthly financial reviews from the CROs and other vendors, and monitor
- Minimum Education Required: Bachelor’s degree in scientific or business discipline.
- Experience in vendor and contract management with a sponsor company or CRO managing various phase clinical trials.
- Experience in CRO, vendor and laboratory selection and oversight.
- Experience in contracts, legal agreements, and financial budgeting preferred.
- Motivated self-starter who is capable of flourishing in a fast-paced small company environment.
- Creative problem solver with excellent communication and public speaking skills.
- Strong interpersonal and organizational skills are needed, with a high degree of attention to detail. Ability to interact well with individuals at all team levels (e.g., Clinical scientist, Project leader, Physician, Finance, QA etc.).
- Strong analytical and problem-solving skills
- Excellent written and oral communication skills
- Proficiency with Microsoft Office (Excel, Word, Outlook, PowerPoint, SharePoint)
- Flexible approach to change
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.
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