Clinical Development Scientist

Artbio • Cambridge, MA

6d

About The Position

ARTBIO is seeking a Clinical Development Scientist to serve as the day-to-day clinical lead for one of its Radioligand Therapy (RLT) development programs. The role combines scientific ownership of the study with hands-on project management, including protocol design and authorship, study-team leadership, timeline management, and interpretation of emerging clinical data to inform program decisions. The position reports to the VP, Clinical Development and works closely with functional heads and subject matter experts.

The scientist contributes to clinical development strategy and study design; leads clinical data review and safety and dose-escalation decision processes; supports regulatory submissions and clinical documentation; and engages with sites, investigators, vendors, and external scientific groups. The role is based in ARTBIO’s international, collaborative biotech environment and offers exposure to imaging and clinical development, training, and professional development opportunities.

Requirements

• Advanced degree (MSc, PhD, PharmD, MD, or equivalent) in life sciences, pharmacy, medicine, or a closely related discipline.
• At least 4 years of clinical development experience; experience may be in industry or at a CRO and must include hands-on responsibility for at least one oncology study.
• Demonstrated protocol-authoring experience, including at least one protocol taken from concept through approval.
• Hands-on experience with clinical data review, query resolution, and preparation of data packages for safety or dose-escalation committees.
• Experience with early-phase oncology trial design, including dose escalation, DLT definition, and cohort expansion.
• Ability to read and interrogate imaging, dosimetry, pharmacokinetic, and biomarker data.
• Comfort working in a fast-paced biotech environment; hands-on and self-directed.
• Collaborative team player able to work with cross-functional flexibility.
• Detail-oriented while maintaining sight of the overall program.
• Commitment to safety, quality, continuous improvement, and staying current with industry trends and advances.

Nice To Haves

• Direct experience with radiopharmaceutical oncologic therapies.
• Experience with prostate cancer therapies and the treatment landscape.
• Experience conducting studies in the US, Australia, and Europe.

Responsibilities

• Contribute to the clinical development plan for the assigned asset, including dose-escalation strategy, cohort design, and endpoint selection.
• Author clinical study protocols, amendments, and informed consent forms, and coordinate cross-functional review through approval.
• Translate preclinical, dosimetry, and emerging clinical data into study design.
• Serve as the day-to-day clinical lead and primary cross-functional point of contact for the assigned asset.
• Chair or co-chair study-team meetings, set agendas, drive decisions to closure, and track actions to completion.
• Manage the study budget and forecast in partnership with Clinical Operations and Finance.
• Own ongoing clinical data review and scientific data cleaning in partnership with the Medical Monitor and data management.
• Prepare and run Safety Review Committee and dose-escalation meetings, including data packages, dose recommendations, minutes, and follow-through.
• Support safety surveillance, SAE reconciliation, and signal evaluation.
• Contribute to statistical analysis plans and review statistical outputs.
• Prepare clinical data and interpretation for internal governance, investor, and partner interactions.
• Contribute clinical content to IND/CTA submissions, Investigator's Brochures, DSURs, briefing books, and responses to health authority questions.
• Contribute to clinical study reports and ensure the clinical narrative is supported by the data.
• Support site feasibility, selection, and activation.
• Deliver protocol training at site initiation visits and investigator meetings, and act as the clinical escalation point for protocol questions.
• Build relationships with investigators, steering committee members, and advisory boards.
• Contribute to abstracts, posters, manuscripts, and congress presentations.

Benefits

• Hands-on training and professional development opportunities.
• International, collaborative, and supportive work culture.
• Competitive compensation and benefits.
• Opportunity to contribute to first-in-class cancer therapies and gain exposure to imaging and clinical development in a dynamic biotech setting.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level