CMC Clinical Supplies and Logistics Manager

Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates® as well as fully synthetic Bicycle® systemic immune cell agonists and Bicycle tumor-targeted immune cell agonists (Bicycle TICAs) focused on oncology indications with high unmet medical need. Bicycle is headquartered in Cambridge, UK, and our US operations run out of 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 have an exciting opportunity for an experienced CMC Clinical Supplies and logistics Manager  to join the Bicycle team and provide logistics support to our expanding preclinical and clinical portfolio.  Reporting to the Associate Director, Clinical Supply Chain, the CMC Clinical Supplies and logistics Manager will be responsible for ensuring that Investigational Medicinal Product (IMP) is labelled, packaged, released, shipped, and distributed to clinical sites in a timely manner and in accordance with cGMP/GDP/GCP guidelines. Inventory management and IMP use forecasting is a key function of the role, ensuring that IMP manufacturing campaigns are aligned with projected clinical usage to ensure uninterrupted supply.

You will have a track record of managing clinical supply chains for international clinical studies, as well as a strong practical understanding of the regulatory landscape for distribution of IMP.  Strong communication skills and experience of managing multiple internal and external international partners is essential.  

Key Responsibilities

The CMC Clinical Supplies and logistics Manager works to ensure continuous supply of IMP for assigned clinical trials through effective monitoring and liaison with the internal CMC and clinical operations teams alongside proactive management of external distribution and Interactive Response Technology (IRT) providers.

You will have the responsibility for the day-to-day CMC Logistics, inventory management and supply chain management to support Bicycle Therapeutics clinical programs to include:

• Ensuring Importer of record, import licenses and in country regulatory requirements are in place for global shipments of clinical supplies
• Budget tracking
• Effective collation and management of IMP inventory in collaboration with both internal (CMC/Clinical) and external partners.
• Management of comparator IMPs in global studies
• Establish and implement defined packaging, distribution and, if appropriate, IRT plan to supply study drug to global clinical trials using sound supply chain techniques
• Implements and monitors inventory management plans that may have complex supply chains
• Where implemented, leverages the inventory management capabilities of the IRT to appropriately manage studies
• Stays abreast and up to date with relevant cGMPs, GCPs, and other regulatory requirements/guidance and ensures study management activities are appropriately aligned
• Attend relevant study-related meetings and represent status of the Clinical Supply Chain as appropriate
• Ability to work as part of a cross-functional team for study management activities
• Utilizes understanding of Clinical Trial Supply Chain Management best practice principles to suggest improvements to existing business processes and supports development of associated training material and documentation
• Other duties may be assigned to meet the needs of the business

Essential requirements

• Educated within relevant subject matters or equivalent career experience
• Demonstrated Supply Chain experience, either in Logistics, with working knowledge of international shipment and import/export of IMP and importer of record
• Demonstrated experience in successfully managing projects in a proactive manner
• Demonstrated experience with multiple global clinical trials
• Proven track record of managing external service providers to ensure optimal delivery to time, cost and quality
• Strong interpersonal skills and experienced in presenting to senior management
• Good computing skills in MS Office suite software
• Strong team player with good motivational skills, and ability to work independently and comfortable to lead
• Ability to work in a flexible, collaborative style with colleagues and teams within the company and with external service providers
• Ability to handle complex information

• State-of-the-art campus environment with on campus restaurant and Montessori nursery  
• Flexible working environment  
• Competitive reward including annual company bonus  
• Employee recognition schemes  
• 28 days annual leave in addition to bank holidays + option to buy up to 5 additional days annually 
• Employer contribution to pension (employee does not have to contribute)  
• Life assurance cover 4x basic salary  
• Private Medical Insurance, including optical and dental cover
• Enhanced parental leave policies 
• Group income protection 
• Employee assistance program  
• Health Cash Plan 
• Access to company subsidized gym membership  
• Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.  
• Cycle to work scheme  

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.