Director, Translational Sciences and Diagnostics

Posted 18 Days Ago
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Cambridge, Cambridgeshire, England
Senior level
Biotech
The Role
The Director of Translational Sciences and Diagnostics will oversee the development of translational strategies for preclinical programs, manage biomarker strategies, and coordinate scientific studies with internal and external collaborators.
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

The Translational Sciences and Diagnostics department is looking to hire a Director to support and oversee the development and execution of Translational strategies for our emerging pipeline of preclinical Bicycle Drug and Radio-conjugate programs. In collaboration with our Research and Innovation (R&I) colleagues, the successful candidate will be responsible for advising on target selection, developing predictive and pharmacodynamic (PD) biomarker strategies, including developing PK-PD-E modelling, and investing in clinical biomarker assay development to support pre-clinical assets from concept to Candidate Selection. Execution of the duties of this role will require co-ordination of activities supporting biomarker strategies internally within and across the Translational Sciences and R&I departments as well as managing scientific studies with a range of CRO’s, external collaborators and clinical investigators. The aim of these studies will be to gain a deep understanding of portfolio asset MOA alongside development of patient stratification and/or PD biomarkers. This position will report to the SVP of Translational Sciences & Diagnostics.

  • Contribute to early development of the Bicycle discovery pipeline as the Translational team representative for all preclinical programs as well as new target identification efforts
  • Own development and implementation of biomarker strategies for all preclinical Bicycle Drug and Radio-conjugate programs
    • Identify pharmacodynamic assays for utility in pre-clinical and future clinical testing to help define PK/PD/efficacy relationships.
    • Lead primary analyses of pre-clinical translational biomarker studies, including evaluation of patient selection strategies
  • Author and review the translational sections of regulatory documents (IND, clinical protocols) as well as scientific/clinical publications and present pre-clinical translational findings at scientific congresses
  • Develop effective working relationships across the Translational Sciences and R&I departments to manage diverse scientific studies with internal teams, CRO’s and external collaborators
  • Additional responsibilities as needed and directed

Qualifications

Essential:

  • MS or PhD (preferred) in biochemistry, molecular cellular biology, pharmacology, medical science, or related field
  • 5+ years of drug development experience in industry in oncology, including direct contributions to early drug development programs
  • Experience in developing biomarker strategies in oncology drug development, including knowledge of GCP
  • Outstanding track record of scientific achievement
  • Excellent verbal and written communication and organizational skills with demonstrated success in leading pre-clinical projects and interacting with cross functional teams
  • Ability to navigate, problem-solve, execute, and lead in a dynamic, fast-paced and evolving environment

Desirable:

  • Experience in managing scientific teams and research in an externalized setting
  • Experience with authoring pre-clinical biomarker data packages as part of IND submissions
  • Knowledge and experience in developing preclinical packages for diagnostic imaging modalities
  • Familiarity with current biomarker regulatory frameworks in different regions

Additional 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.

Top Skills

Biomarker Strategies
Drug Development
Pharmacodynamics Modeling
Scientific Publications
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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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