Job Title:
Associate Director, Clinical Pharmacology

Company: Bicycle Therapeutics

Location: cambridge, MA

Created: 2024-04-23

Job Type: Full Time

Job 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:WeareAdventurous.We believe it'sthewaytodeliverextraordinaryresultsforourpatients.WeareDedicatedtoourMission.Youcan'tchangetheworldifyoudon'thavedetermination.WeareOneTeam.Weonlysucceedwhenweworktogether.Job DescriptionWe 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 studiesPerform andor guidepharmacokinetic and pharmacodynamic data analysisDraft andor review PK related reports (eg. NCA, population PK, exposure-response analysis)Contribute to the design and development of Clinical Pharmacology submission documents for regulatory filingsCollaborate cross-functionally with other departments, including Clinical, Regulatory, Translational Science, Biometrics, Clinical Operation and PharmacovigilanceQualificationsEssential:PharmD or PhD with a minimum of 3 years of biopharmaceutical experience in Clinical Pharmacology andor PharmacometricsHands-on experience designing, conducting and interpreting clinical pharmacology studiesDemonstrated expertise in preparing clinical pharmacology documents (protocols, pharmacokinetic reports, CSRs, etc.) and the preparation of regulatory documents and submissions (INDs andor NDAs)An established track record of scientific project management, and an ability to lead multiple initiatives in a dynamic and fast paced environmentStrong interpersonal skills and can-do attitude with flexibility and ability to adaptDesirable:Direct drug development experience within oncology is desired but not requiredHands-on experience on population PKPD models, exposure-response analysis, and other standard forms of modeling and simulation, is highly desirableAdditional InformationFlexible working environmentCompetitive reward including annual company bonusMedical, dental, and vision insurance for eligible employees and their families with 100% of the premiums covered by the CompanyHealth and Dependent Care Flexible Spending Accounts401(k) plan with a 4% Company match and immediate vestingEligibility to accrue up to 23 paid time off days per full year worked, plus the option to buy up to 5 additional daysEmployee assistance programEmployee recognition schemes10 Company holidaysCompetitive Family Leave PolicyEligibility 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.