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, including hands-on responsibility for at least one oncology study.
Demonstrated protocol authoring experience, with at least one protocol taken from concept through to approval.
Hands-on experience in clinical data review and preparation of data packages for safety or dose-escalation committees.
Experience with early-phase oncology trial design, including dose escalation and cohort expansion.
Ability to read and interrogate imaging, dosimetry, pharmacokinetic and biomarker data.
Responsibilities
Contribute to the clinical development plan, including dose-escalation strategy and endpoint selection.
Author clinical study protocols and coordinate cross-functional review for approval.
Translate preclinical and emerging clinical data into study design.
Serve as the day-to-day clinical lead and primary point of contact for the assigned asset.
Chair study team meetings, set agendas, and track actions to completion.
Manage study budget and forecast in partnership with Clinical Operations and Finance.
Prepare and run Safety Review Committee meetings, including data packages and dose recommendations.
Benefits
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.
Full Job Description
Summary
We are seeking a Clinical Development Scientist to act as the day-to-day clinical lead for one of ARTBIO's Radioligand Therapy (RLT) development programs, combining scientific ownership of the study with hands-on project management of its execution. Reporting to the VP, Clinical Development and working closely with functional heads and subject matter experts, you will be the person who holds the program together: designing and authoring the protocol, chairing the study team, driving the timeline, and turning emerging clinical data into the decisions that advance the asset.
Responsibilities
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.
Qualifications & Education
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.
Preferred
Direct experience with radiopharmaceutical oncologic therapies.
Experience with prostate cancer therapies and landscape.
Experience of studies conducted in both the US, Australia and Europe.
Personal Attributes
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.
What We Offer
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.
