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Day One Biopharmaceuticals · 13 hours ago

Director, Clinical Pharmacology

United States

Full-time

Remote

Director/Executive

$220K/yr - $240K/yr

10+ years exp

Day One Biopharmaceuticals is focused on advancing innovative medicines for childhood and adult diseases. They are seeking a Director of Clinical Pharmacology to lead early-stage clinical programs, focusing on dose selection and optimization for antibody drug conjugates (ADC). The ideal candidate will have a strong scientific background and a collaborative mindset to drive clinical pharmacology strategy and execution.

BiopharmaBiotechnologyHealth CarePharmaceutical

No H1B

Responsibilities

Serve as the Clin Pharm lead for one or more ADC programs within cross-functional team:

Lead dose selection and optimization in support of early-stage clinical development and decision-making; you are expected to be SME on dose selection and optimization

Provide clear and actionable recommendations to the cross-functional team by review, analysis, and interpretation of PK, PD, and exposure-response data; you are expected to be the primary expert on your data and prepared to discuss it confidently and accurately at any time

Drive clinical pharmacology strategy and execution with direct accountability for data integrity and scientific interpretation

Translate cross-functional questions into clear, actionable Clin Pharm objectives with defined scopes of work and timelines

Author and maintain a comprehensive Clinical Pharmacology Plan, ensuring timely execution of deliverables

Author or co-author, and critically review key program documents including Investigator’s brochure, clinical trial protocols, study reports, and regulatory submission documents

Collaborate with Medical Affairs to support scientific communications, including abstracts, posters, and manuscripts for conferences and peer-reviewed publications

Respond to clinical pharmacology-related inquiries from medical monitors, investigators, and cross-functional stakeholders

Lead clinical pharmacology input and strategy for regulatory interactions, including written responses and meetings with Health Authority

Oversee external vendors: monitor vendor performance to ensure alignment with scientific and operational expectations and provide timely, constructive feedback to support high-quality deliverables and effective collaboration

May serve as a strategic leader for the clinical program:

Identify and proactively resolve issues that may impact the programs execution (e.g., data quality or timelines)

Influence program direction using integrated scientific, clinical, and business insights

Provide leadership and mentorship to junior colleagues or contractors, including effective delegation, professional development, and performance support

Qualification

Clinical PharmacologyAntibody Drug Conjugates (ADC)PharmacokineticsData AnalysisRegulatory SubmissionsStrategic ThinkingCollaborationCommunication SkillsMentorship