Working Classification:At Bicycle, we benefit from a hybrid style working arrangement, allowing employees where possible the opportunity to collaborate and engage with their coworkers in person while also benefiting from the flexibility of remote working. A typical hybrid arrangement for this role is
3 days onsite per week at our Lexington, MA office, with the remainder of your working week remote.
Job DescriptionTHE ROLE (The Mission) Your 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.
YOUR RESPONSIBILITIES - Clinical Trial Strategy & Design:
- 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.
- Data Analysis & Interpretation:
- 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.
- Scientific & Program Leadership:
- 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.
- Collaboration & External Engagement:
- 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.
WHO ARE YOU: SKILLS & COMPETENCIESKnowledge & Expertise:- Core Expertise: You provide recognized expertise in clinical science, influencing the clinical strategy for these key programs.
- Data / Insight: You shape clear recommendations from complex and often ambiguous clinical trial data to guide critical program decisions.
- Knowledge Sharing: You share insights on clinical development across the organization, strengthening our collective capability and mentoring junior team members.
Job Complexity:- Task / Project Delivery: You oversee and are accountable for the clinical science components of significant and complex clinical programs.
- Problem-Solving: You solve highly complex challenges in trial design and execution with creative and scientifically rigorous approaches.
- Strategic Impact: You directly shape the clinical development strategy for our key assets and influence organization-wide priorities through your deep scientific and clinical insights.
Independence:- Autonomy: You set the scientific strategy and direction for assigned clinical programs with broad autonomy, acting as the key scientific decision-maker in partnership with the physician lead.
- Decision-Making: You make high-impact decisions in uncertain contexts, such as recommending go/no-go decisions for a program based on your interpretation of emerging data.
- Leadership / Mentorship: You empower and mentor other clinical scientists and team members, acting as a role model for scientific rigor and strategic thinking, even without direct line management responsibility.
Values & Behaviors:- One Team: You create strong alignment across multiple functions-including Clinical, Translational, CMC, and Regulatory-to ensure a cohesive and effective program strategy.
- Adventurous: You champion the adoption of transformative ideas in clinical trial design, such as novel imaging endpoints or innovative biomarker strategies, to accelerate our path to patients.
- Dedicated to our Mission: You hold yourself accountable for delivering high-quality clinical science that directly advances our mission to bring novel therapies to patients with high unmet medical needs.
QualificationsWHO ARE YOU: QUALIFICATIONS- 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; experience in radiopharmaceutical trial design, dosimetry, and molecular imaging endpoints is desirable but not essential.
Additional InformationWHAT'S IN IT FOR YOU? - 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.
Compensation - Salary Range: $195,000 - $245,000
