Associate Director, Clinical Pharmacology

3 weeks ago

Cambridge, United States Bicycle Therapeutics Full time
Job DescriptionJob DescriptionCompany Description

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. 
Job Description

We are looking for an Associate Director in Clinical Pharmacology who will be a key member of our multidisciplinary drug development teams. You will serve as Clinical Pharmacology lead to design and execute the various clinical pharmacology components of the Bicycle Therapeutics clinical portfolio.  You should be familiar with current scientific best practice and regulatory guidance in clinical pharmacology, pharmacometrics, pharmacokinetics and drug metabolism.

  • Lead the design, planning, execution, and interpretation of Clinical and Clinical Pharmacology studies
  • Perform and/or guide pharmacokinetic and pharmacodynamic data analysis
  • Draft and/or review PK related reports (eg. NCA, population PK, exposure-response analysis)
  • Contribute to the design and development of Clinical Pharmacology submission documents for regulatory filings
  • Collaborate cross-functionally with other departments, including Clinical, Regulatory, Translational Science, Biometrics, Clinical Operation and Pharmacovigilance
Qualifications

Essential:  

  • PharmD or PhD with a minimum of 3 years of bio/pharmaceutical experience in Clinical Pharmacology and/or Pharmacometrics
  • Hands-on experience designing, conducting and interpreting clinical pharmacology studies
  • Demonstrated expertise in preparing clinical pharmacology documents (protocols, pharmacokinetic reports, CSRs, etc.) and the preparation of regulatory documents and submissions (INDs and/or NDAs)
  • An established track record of scientific project management, and an ability to lead multiple initiatives in a dynamic and fast paced environment
  • Strong interpersonal skills and can-do attitude with flexibility and ability to adapt

Desirable:  

  • Direct drug development experience within oncology is desired but not required
  • Hands-on experience on population PK/PD models, exposure-response analysis, and other standard forms of modeling and simulation, is highly desirable


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.

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