About this Clinical Development Scientist role at Artbio
Summary
Responsibilities
Clinical development strategy and study design
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Contribute to the clinical development plan for the assigned asset, including dose-escalation strategy, cohort design and endpoint selection.
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Author clinical study protocols, amendments and informed consent forms, and coordinate cross-functional review to approval.
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Translate preclinical, dosimetry and emerging clinical data into study design.
Program and project management
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Serve as the day-to-day clinical lead and primary point of contact for the assigned asset across all functions.
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Chair or co-chair study team meetings: set the agenda, drive decisions to closure, and track actions to completion.
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Manage study budget and forecast in partnership with Clinical Operations and Finance.
Data, safety and decision-making
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Own ongoing clinical data review and scientific data cleaning in partnership with the Medical Monitor and data management.
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Prepare and run Safety Review Committee and dose-escalation meetings, including data packages, dose recommendations, minutes and follow-through.
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Support safety surveillance, SAE reconciliation and signal evaluation.
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Contribute to statistical analysis plans and review of outputs.
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Prepare clinical data and interpretation for internal governance, investor and partner interactions.
Regulatory and documentation
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Contribute clinical content to IND/CTA submissions, Investigator's Brochures, DSURs, briefing books and responses to health authority questions.
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Contribute to clinical study reports and ensure the clinical narrative is supported by the data.
Sites, vendors and external engagement
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Support site feasibility, selection and activation.
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Deliver protocol training at site initiation visits and investigator meetings and act as the clinical point of escalation for protocol questions.
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Build relationships with investigators, steering committee members and advisory boards.
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Contribute to abstracts, posters, manuscripts and congress presentations.
Qualifications & Education
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Advanced degree (MSc, PhD, PharmD, MD or equivalent) in life sciences, pharmacy, medicine or a closely related discipline.
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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.
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Demonstrated protocol authoring, including at least one protocol taken from concept through to approval.
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Hands-on experience of clinical data review, query resolution, and preparation of data packages for safety or dose-escalation committees.
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Experience with early-phase oncology trial design, including dose escalation, DLT definition and cohort expansion.
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Ability to read and interrogate imaging, dosimetry, pharmacokinetic and biomarker data.
Preferred
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Direct experience with radiopharmaceutical oncologic therapies.
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Experience with prostate cancer therapies and landscape.
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Experience of studies conducted in both the US, Australia and Europe.
Personal Attributes
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Comfortable working in a fast-paced biotech environment, hands on and self-directed
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Team player who thrives on collaboration and cross-functional flexibility.
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Detail-oriented without losing sight of the program as a whole.
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Commitment to safety, quality, continuous improvement and staying current with industry trends and advances.
What We Offer
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A unique chance to contribute to first-in-class cancer therapies.
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Exposure to both imaging and clinical development in a dynamic biotech setting.
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Hands-on training and professional development opportunities.
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An international, collaborative, and supportive work culture.
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Competitive compensation and benefits.