Director, Clinical Pharmacology
Day One Biopharmaceuticals
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $220,000 - $240,000 per year
Job Level
Lead
About the role
- 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
Requirements
- PhD, PharmD, or equivalent in pharmaceutical sciences, clinical pharmacology, pharmacokinetics, or related discipline.
- 10+ years of industry experience in clinical pharmacology, with a strong preference for hands-on experience in ADC program
- Proven ability to lead in a fast-paced, cross-functional, and collaborative environment.
- Strong written and verbal communication skills, with the ability to clearly convey complex scientific and clinical concepts to diverse audiences.
- Demonstrated strategic thinking coupled with strong attention to detail and operational execution.
Benefits
- Please visit https://www.dayonebio.com/benefits to see our competitive benefits.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical pharmacologydose selectionoptimizationPK analysisPD analysisexposure-response dataClinical Pharmacology Planregulatory submission documentsinvestigator's brochureclinical trial protocols
Soft skills
leadershipmentorshipstrategic thinkingcommunicationcollaborationproblem-solvingattention to detaildelegationprofessional developmentperformance support
Certifications
PhDPharmD