Biomarker Operations, Senior Associate

Posted Yesterday
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Cambridge, MA
Mid level
Biotech
The Role
The Biomarker Operations Senior Associate will coordinate biomarker operations activities, manage laboratory setup, oversee sample management, and collaborate with Translational Sciences and Clinical Operations teams to support clinical trials. They will ensure proper data transfer and reconciliation of biomarker data and establish processes for consistency across trials.
Summary Generated by Built In

Company Description

Bicycle Therapeutics is a clinical-stage pharmaceutical 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 zelenectide pevedotin (formerly BT8009), a Bicycle® Toxin Conjugate (BTC®) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BTC molecule 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 USA

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 seeking a Biomarker Operations Senior Associate to join the Translational Sciences team. This position is highly cross-collaborative, working at the interface of Translational Sciences, Clinical Operations, Data Management and partner CROs. As a key member of a multi-faceted team, you will seamlessly bridge science and operations to support study-specific clinical biomarker strategies. You will be responsible for coordinating all aspects of biomarker operations activities from guiding central laboratory set-up, to overseeing sample management lifecycle, data reporting and reconciliation.

  • Work collaboratively with the Translational Science and Clinical Operations teams to:
    • Support review of biomarker sections in protocols, central laboratory specifications and lab manuals, consent forms, sample analysis plans
    • Manage the implementation of biomarker logistics with the central laboratory throughout the life of the trial
    • Proactively follow-up on biomarker sample and data related queries
  • Become the subject matter expert for study-specific biomarker sample lifecycle, from sample collection, shipment, testing, data transfer, and final disposition
  • With Data Management, support the review of data transfer agreements and the reconciliation of biomarker data and samples
  • Establish biomarker related processes to ensure consistency across clinical trials
  • Develop and maintain long-term storage framework for clinical and pre-clinical samples

Qualifications

Essential:

  • Clinical trial experience
  • Strong organizational and time management skills
  • Attention to detail and accuracy
  • Ability to collaborate, communicate,
  • Proficiency in Microsoft Office Suite
  • Scientific background and basic understanding of data analysis
  • Flexible, organized and motivated individual who enjoys working in a fast-paced, small company environment

Desirable:

  • Proficiency in Smartsheets

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.

The Company
HQ: Lexington, MA
209 Employees
On-site Workplace
Year Founded: 2009

What We Do

We are Bicycle Therapeutics, a clinical-stage biopharmaceutical company. We didn’t wait for the next advance against cancer. We created it.

Based on groundbreaking work conceived in the laboratory of Sir Greg Winter with the help of Professor Christian Heinis, we are pioneering the development of bicyclic peptides, or Bicycles® – a novel class of versatile, chemically synthesized medicines. Bicycles are fully synthetic short peptides constrained to form two loops which stabilize their structural geometry. This constraint is designed to confer high affinity and selectivity, and the relatively large surface area presented by the molecule allows targets to be drugged that have historically been intractable to non-biological approaches. Bicycles represent a unique therapeutic class, combining the pharmacological properties normally associated with a biologic with the manufacturing and pharmacokinetic advantages of a small molecule, yet with no signs of immunogenicity observed to date.

Bicycles can be used as Bicycle conjugates to deliver toxin payloads and to precisely target local immune activation within tumors and as Bicycle T-cell modulators, which activate cytotoxic T-cells while circumventing the limitations of antibody and biologic therapies and better enabling combination therapy. Our lead product candidate, BT1718, is a Bicycle toxin conjugate currently being investigated in a Phase I/IIa open label dose escalation and expansion clinical trial sponsored by Cancer Research UK. BT1718 targets Membrane Type 1 Matrix Metalloproteinase (MT1-MMP), also known as MMP-14, which is highly expressed in many solid tumors.

Our strategic collaborations are based on the ability of Bicycles to address a wide variety of targets. Through collaborations with AstraZeneca, Oxurion, Innovate UK and the Dementia Discovery Fund, we work with companies that have deep therapeutic expertise outside of oncology to enable us to more efficiently develop novel medicines for patients.

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