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Associate Director, Clinical Pharmacology
3 weeks ago
Company 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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