Day One Biopharmaceuticals logo
Day One Biopharmaceuticals

Cancer drug development comes of age.

Director, Clinical Pharmacology

DirectorDirectorFull TimeRemoteLeadTeam 11-50Since 2018H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

91 days ago

Salary

$220K - $240K / year

Seniority

Lead

Postgraduate Degree10 yrs expEnglish

Job Description

• 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

Job 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.

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