Clinical Development Scientist in Cambridge, Massachusetts at ARTBIO

Clinical development strategy and study design

• 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 to approval.

• Translate preclinical, dosimetry and emerging clinical data into study design.

Program and project management

• Serve as the day-to-day clinical lead and primary point of contact for the assigned asset across all functions.

• Chair or co-chair study team meetings: set the agenda, drive decisions to closure, and track actions to completion.

• Manage study budget and forecast in partnership with Clinical Operations and Finance.

Data, safety and decision-making

• 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 of outputs.

• Prepare clinical data and interpretation for internal governance, investor and partner interactions.

Regulatory and documentation

• 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.

Sites, vendors and external engagement

• Support site feasibility, selection and activation.

• Deliver protocol training at site initiation visits and investigator meetings and act as the clinical point of escalation for protocol questions.

• Build relationships with investigators, steering committee members and advisory boards.

• Contribute to abstracts, posters, manuscripts and congress presentations.

• Advanced degree (MSc, PhD, PharmD, MD or equivalent) in life sciences, pharmacy, medicine or a closely related discipline.

• Minimum 4 years of clinical development experience for appointment. Experience may be gained in industry or at a CRO and must include hands-on responsibility for at least one oncology study.

• Demonstrated protocol authoring, including at least one protocol taken from concept through to approval.

• Hands-on experience of 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.

• Direct experience with radiopharmaceutical oncologic therapies.

• Experience with prostate cancer therapies and landscape.

• Experience of studies conducted in both the US, Australia and Europe.

• Comfortable working in a fast-paced biotech environment, hands on and self-directed

• Team player who thrives on collaboration and cross-functional flexibility.

• Detail-oriented without losing sight of the program as a whole.

• Commitment to safety, quality, continuous improvement and staying current with industry trends and advances.

• A unique chance to contribute to first-in-class cancer therapies.

• Exposure to both imaging and clinical development in a dynamic biotech setting.

• Hands-on training and professional development opportunities.

• An international, collaborative, and supportive work culture.

• Competitive compensation and benefits.