Manager, Clinical Business Operations

Job Description

Job Description

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 Manager, Clinical Business Operations, who will be responsible for ensuring efficient, accurate clinical trial study cost, reporting and forecasting by monitoring the clinical supplier and clinical site budgets.

The right candidate will possess an understanding of the details that go into clinical budgets by supporting the analysis of clinical budgets, managing changes in the budget, and lead the reconciliation of multiple clinical trials primarily in oncology indications in various phases of development.

They will work closely with other members of the clinical operations, legal, and finance teams in purchase order and invoice reconciliation, forecasting, and accrual management of the clinical contracts.

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

• Manages the overall Purchase Order (PO) of the clinical contract from start through start to finish.
• Works with the clinical operations teams in providing and assessing accruals
• Reviews quarterly financial reporting to ensure the budgets are aligned with the contract, and current study status.
• Reviews the financial KPIs of the Clinical suppliers, and work with the vendors to improve the assessment
• Works on creating process and building efficiencies across clinical programs to optimize financial oversight
• Works with the clinical teams in assessing invoices and escalations
• Builds benchmarking assessments and tools across similar type clinical studies budgets and clinical sites
• Supports the Outsourcing Management team in the identification and selection process of clinical vendors such as CROs, central labs, imaging by analyzing the unit costs assessment to ensure cost are within agreed rate card and current bench marking
• Supports the creation and management of preferred provider relationships, functional service provider, negotiated rate cards, volume discounts, and rebate structure etc.
• Assists in the creation of score cards and analysis of scores during the RFP stage.
• Participates in pricing negotiations for CROs and other critical study vendors.
• Manages work order amendments and change orders to ensure appropriate pricing and timely execution
• Works closely with finance to assure the assumptions for studies are aligned between finance and clinical forecasting.
• Supports the development and maintaining RFP budget templates, Change Order and Change Notification Form trackers and out of scope logs
• 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 for forecasting, sourcing and contracting
• Supports the development of the Clinical Outsourcing and Business Operations department infrastructure with assisting in developing process documents, input to SOPs, provide training to others, and administrative duties as requested.

Qualifications

• Minimum Education Required : Bachelor’s degree in scientific or business discipline.
• The candidate should have experience in Business Operations and / or vendor outsourcing and contract management experience 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.