Director, Clinical Scientist

Bicycle Therapeutics•Lexington, MA

2d•$195,000 - $245,000•Hybrid

About The Position

The mission is to serve as a clinical science leader for one of our innovative programs. You will apply your deep expertise in trial design, data interpretation, and translational science to drive our novel assets from early clinical development through to pivotal studies. As the key scientific partner to the physician lead, you will shape clinical strategy and ensure the rigorous execution of trials that will define the future of our therapies and bring them to patients in need.

Requirements

Advanced scientific or clinical degree (e.g., PhD, PharmD, advanced nursing degree, or equivalent) with extensive clinical research experience in the biotech/pharmaceutical industry.
Experience in the design and execution of clinical trials, with a deep understanding of protocol development, data analysis, and study reporting.
Thorough knowledge of GCP/ICH guidelines and current regulatory requirements.
Demonstrated ability to interpret complex scientific and clinical data and translate it into actionable strategies.
Excellent written communication, oral communication, and presentation skills.
Strong ability to critically analyze, interpret, and present complex clinical data to a variety of internal and external audiences.
Experience in oncology is essential.

Nice To Haves

Experience in radiopharmaceutical trial design, dosimetry, and molecular imaging endpoints is desirable but not essential.

Responsibilities

Lead the scientific design of clinical studies, providing expert input on study endpoints, patient population, and biomarker strategies.
Serve as the scientific author for clinical trial protocols and amendments, ensuring they are aligned with the overall program strategy and incorporate key principles of clinical development.
Maintain a deep and current understanding of the competitive and scientific landscape to ensure our trial designs are innovative and effective.
Lead the ongoing, rigorous review and interpretation of clinical trial data, including safety, efficacy, pharmacokinetics, and translational data.
Translate complex datasets into clear scientific narratives and actionable insights, guiding critical program decisions such as dose escalation and cohort expansion.
Partner with Biometrics and Translational Science to develop and execute analysis plans that fully explore trial data.
Serve as the primary clinical science expert for assigned programs, acting as the key partner to the Clinical Lead (MD) and the broader development team.
Drive the scientific content for key clinical and regulatory documents, including Investigator's Brochures, Clinical Study Reports, and sections of regulatory filings (INDs, CTAs, BLAs).
Present scientific rationale, clinical data, and program updates to internal governance bodies and external stakeholders.
Collaborate with and provide scientific training to Clinical Operations, CRO partners, and clinical site staff to ensure the highest quality trial execution.
Build and maintain strong relationships with key opinion leaders and clinical investigators in the radiopharmaceutical field.
Act as a key scientific representative of the company at investigator meetings, advisory boards, and scientific conferences.

Benefits

401(k) plan with a 4% Company match and immediate vesting
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
Employee assistance program (EAP)
Time off (eligibility to accrue up to 23 paid time off days per full year worked, the option to buy up to 5 additional days & 10 company nominated holidays)
10 Company holidays
Competitive reward including annual company bonus
Employee recognition schemes
Enhanced parental leave policies
Flexible working environment
Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.