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Senior Clinical Trial Manager

2 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.


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


The Senior Clinical Trial Manager will support the team in the planning, implementation, and oversight of Bicycle’s clinical trials to ensure it is conducted in accordance with study plans. He/she will execute on decisions and strategies for achieving clinical program objectives, and partner with matrixed functions such as clinical sciences, translational sciences, medical, program management, and finance. He/she will also interact frequently with external parties, such as study sites, vendors, investigators, and advisors.


The position will be a member of the Clinical Operations group, reporting to the Associate Director, Clinical Operations


Key responsibilities:


  • Lead clinical study project activities include site activation, patient enrolment, investigator meetings, data management, and study drug supply, among others
  • Support and provide guidance to the study team to execute the clinical study in accordance with the clinical development plan/strategy and timelines
  • Lead the oversight of activities at the CRO and other clinical vendors; monitor status and provide real-time updates to program team; facilitate communication between Bicycle and the Clinical CRO


Lead activities in:

  • Contracting and activation of study sites
  • Preparation and submission of IRB/EC packages
  • Planning and conduct of investigator meetings
  • Coordination of study drug and study supplies
  • Management of patient sample collection, archival, and distribution to vendors
  • Collection or preparation of study-related documents
  • May perform periodic visits to sites and/or CROs to assess progress of studies/protocol compliance and monitoring oversight.


Qualifications


Essential:


  • Bachelor’s degree in scientific, biological, life sciences, or related field
  • Demonstrable experience with ICG, GCP, and FDA requirements, as applicable, for clinical trial management
  • Strong project management and organization skills; demonstrated ability to complete a task from start to finish
  • Experience managing clinical CROs and/or clinical vendors
  • Experience managing a budget and providing frequent updates on spend vs. budget
  • Strong organizational skills and enjoys working in a methodical way
  • Strong analytical and problem-solving skills
  • Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment
  • Attention to detail and quality
  • Excellent written and oral communication skills
  • Proficiency with Microsoft Office (Excel, Word, Outlook, PowerPoint, SharePoint)
  • Flexible approach to change


Desirable:

  • Early phase and/or Oncology experience


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
  • 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.