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CMC Senior Clinical Supplies Manager

3 months ago

Cambridge UK, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

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.

Cultureis key and all Bicycle employees actively embrace and role model our company values: 

  • We areAdventurous. We believe it's the way to deliver extraordinary results for our patients.
  • We areDedicated to our Mission. You can't change the world if you don't have determination
  • We areOne Team. We only succeed when we work together.

Job Description

We have an exciting opportunity for an experiencedCMC Senior Clinical Supplies Managerto join the Bicycle team and provide logistics support to our expanding preclinical and clinical portfolio. Reporting to the Director, Clinical Supply Chain, the CMC Senior Clinical Supplies 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 Senior Clinical Supplies 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 inventory management and clinical supply chain management of all of the Bicycle Therapeutics clinical programs to include:

  • Effective collation and management of IMP inventory in collaboration with both internal (CMC/Clinical) and external partners.
  • 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
  • Sourcing of comparator drug
  • Vendor management
  • 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

Qualifications

Essential requirements

  • Educated within relevant subject mattersor equivalent career experience
  • Demonstrated Supply Chain experience, either in Logistics, IRT, and/or Packaging, with working knowledge of international shipment and import of IMP
  • 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

Additional Information

  • State-of-the-art campus environmentwith 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.
  • 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.