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Director, Pharmacometrics
4 months ago
Bicycle Therapeutics is a clinical-stage biopharmaceutical 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 BT8009, a Bicycle® Toxin Conjugate (BTC®) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BTC 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.
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.
The Director of Pharmacometrics, reporting to the head of Pharmacometrics within the Quantitative Pharmacology group, will implement model informed drug development (MIDD) for assets in preclinical and/or clinical stages at Bicycle Therapeutics. The role will serve as a subject matter expert on pharmacometrics and a key member of our multidisciplinary Quantitative Pharmacology team which includes Clinical Pharmacology, Pharmacometrics, DMPK and Bioanalysis. You will be responsible primarily for leveraging quantitative disciplines and techniques, including population PK, PK/PD, PBPK, QSP, and exposure-response modeling and simulations, to integrate data and knowledge across various sources and inform decision-making.
- Formulate pharmacometric strategies for assigned programs with limited supervision;
- Work independently or with external vendor(s) to deliver pharmacometric analysis plans, analysis results, and reports;
- Interpret and communicate pharmacometric findings to stakeholders to inform or influence decision-making, e.g., dose selection and optimization, dose adjustment for subpopulations, study design;
- Support preclinical study design, eg. dose finding, PK and TK studies and analyze and interpret data to support decision-making;
- Perform PK/PD data analysis to support human dose prediction for FIH studies;
- Support preparation of nonclinical and/or clinical study documents, e.g., study protocols, TK reports, study reports, DSURs, etc;
- Support clinical and/or nonclinical pharmacology summary documents for regulatory submissions (such as INDs, briefing book, IB, CTA, CTD Module 2 documents, product labeling);
- Collaborate cross-functionally with other departments, including Biology, In Vivo Pharmacology, Clinical, Regulatory, Translational Science, Biometrics, Clinical Operations, and Pharmacovigilance;
- Lead or support infrastructure initiatives and/or cross-functional best practice initiatives;
- Maintain a high standard for good clinical practice, compliance and ethics.
Essential:
- Solid knowledge in pharmacology, pharmaceutics, or engineering-related disciplines with a quantitative mindset;
- Industrial experience in Pharmacometrics and/or Clinical Pharmacology;
- Hands-on skills and experience in population PK/PD, exposure-response analyses, PBPK, translational modeling;
- Proficiency in software such as NONMEM, R, Monolix, or other modeling tools commonly used in pharmacometrics;
- Hands-on experience in writing /contributing to DMPK or clinical pharmacology documents (protocols, PMx reports, CSRs, etc.);
- Strong oral and writing communication skills to thrive in cross-functional teams;
Desirable:
- Experience in oncology therapeutic area;
- Experience in supporting development of ADCs, biologics, immuno-oncology therapeutics, bispecific antibodies, or radiopharmaceutics;
- Experience in regulatory submissions or regulatory interactions;
- 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.
All your information will be kept confidential according to EEO guidelines.
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.
