Job Description

The Bioanalytical Study Manager will report to the Senior Bioanalytical Study Manager and will be responsible for the management and oversight of the external Contract Research Organizations (CRO) that support our clinical pipeline. The candidate will support all aspects of bioanalytical vendor management activities to develop, validate and troubleshoot bioanalytical method development and the subsequent routine bioanalysis of preclinical and clinical regulatory studies.

KEY RESPONSIBILITIES

• Serve as a bioanalytical LC-MS/MS subject matter expert for the Quantitative Pharmacology group and its stakeholders.
• Collaborate with Clinical Pharmacology leaders and Project Teams, including internal nonclinical and clinical development teams to define and implement bioanalytical support for team objectives.
• Provide routine and thorough review of vendor deliverables, including quantitative data sets, reports, analytical study plans, preclinical protocols, validation and R&D study reports (fit-for-purpose and regulated) and data transfer agreements for Bicycle’s preclinical and clinical Bicycle Toxin Conjugates (BTC) and Tumor Immune Cell Agonist (TICA) programs.
• Provide routine operational and business support to the Quantitative Pharmacology group to assist in the generation and execution of quotations, statements of work (SOWs), contract approval forms and purchase orders.
• Maintain vendor relationships and readiness through regular interactions, correspondence, and site visits (where appropriate).
• In collaboration with Clinical Pharmacology lead and Clinical Operations team, manage tracking, logistics, primary record keeping and sample quality of bioanalysis samples.
• Support Bioanalytical readiness for regulatory submissions.

Qualifications

Essential:

• First degree in Biology, Chemistry, or a related field.
• Experienced bioanalytical scientist with extensive hands-on experience in liquid chromatographic mass spectrometric detection (LC-MS/MS and HRMS) in a regulated bioanalytical sciences environment.
• Extensive and hands-on experience in the fortification, sample preparation and extraction techniques routinely used for mass spectrometric based detection in a regulated setting.
• Expert understanding of the relevant bioanalytical regulations and guidance including GLP, FDA, EMA, ICH M10.
• Extensive experience in managing and directing bioanalytical support at external vendors, consultants and CROs.
• Ability to prioritize and support multiple projects among a variety of different bioanalytical lifecycle stages and milestones (preclinical, clinical, fit-for-purpose, assay development, routine portfolio analysis, auditing, report writing, etc.).
• Exceptional organization and communication (verbal and written) skills – able to collaborate and build strong relationships in both a remote and an office-based environment.
• Proficiency with computers and software relevant to bioanalytical sciences, including cloud/server-based file sharing systems, LIMS, Analyst, etc.
• General understanding of drug discovery and development and the importance of bioanalysis within it.

Desirable:

• Experience in the regulated assay development of ADCs and their associated cytotoxic payloads, new peptide modalities such as peptide drug conjugates (PDCs) or bi-specific antibodies using mass spectrometric detection.
• Demonstrated experience in compliance and quality oversight of laboratories supporting regulated bioanalytical activities.
• Knowledge of QA compliance and audit activities and/or report review
• Experience with regulatory agency interactions and/or inspections (FDA, EMA).
• Experience in the use of cloud-based productivity and collaboration platforms such as Smartsheet

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.

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.