Director, Clinical Pharmacology – DMPK
Braveheart Bio
full-time
Posted on:
Location Type: Hybrid
Location: San Francisco • California • United States
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Salary
💰 $208,000 - $265,000 per year
Job Level
About the role
- Lead all aspects of execution and oversight across nonclinical and clinical programs
- Serve as the primary liaison to external CROs, ensuring scientific quality, regulatory compliance, and timely delivery of data
- Partner cross functionally with CMC, Clinical Operations, and Regulatory to support advancement of our phase 3-ready asset
- Manage all CRO relationships related to bioanalysis, including selection, contracting, technical oversight, and performance tracking
- Ensure timely and compliant sample collection, shipping, and analysis in alignment with GxP requirements
- Experience developing population PK models and integrating them into pivotal program planning
- Familiarity with regulatory expectations for Clinical Pharmacology in NDA/MAA filings, including labeling language
- Strong partnership with clinical development, ensuring study protocols incorporate appropriate PK sampling and CDISC-aligned data plans
- Lead the Clinical Pharmacology components of global regulatory interactions (FDA, EMA)
- Alignment of Clinical Pharmacology strategy with cross-functional program priorities and commercial considerations
- Effective communication to simplify complex concepts for clinical investigators, executives, and external partners
- Collaboration with Clinical Operations, Safety, Biometrics, and Regulatory.
- Guiding the company through decision-making (interim analyses, dose adjustments, safety reviews)
- Oversight of high-quality PK sample handling, assay readiness, and data processing workflows
- Building fit-for-purpose processes that scale as the company moves from Phase III to registration
- Operate independently as the sole internal Clinical Pharmacology expert
- Be proactive and resourceful, with the ability to step beyond a narrow functional box when needed
- Influence without direct authority—shape strategy through clarity, data, and presence rather than team size
- Thrive in a fast-moving environment and adjust strategy rapidly as clinical data emerge.
Requirements
- Advanced degree (PhD, PharmD, or MS with extensive industry experience) in a relevant field such as Pharmaceutical Sciences, Bioanalysis, or Pharmacokinetics
- At least 8 years of industry experience in bioanalysis, DMPK, or clinical pharmacology within biotechnology or pharmaceutical R&D
- Proven experience managing bioanalytical CROs and overseeing assay validation, sample analysis, and data delivery for clinical-stage programs
- Strong understanding of PK principles, LC-MS/MS assay validation, and regulatory guidance (FDA, EMA, ICH)
- Demonstrated ability to interpret, communicate, and integrate complex bioanalytical and pharmacokinetic data
- Experience supporting Phase 2–3 programs with exposure to clinical pharmacology components (first-in-human through registrational studies)
- Excellent organizational and vendor management skills in a dynamic, fast-paced environment
- Strong written and verbal communication skills with a collaborative, team-oriented approach
- Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity
- Flexible, proactive, and hands-on mindset with a roll-up-your-sleeves, can-do attitude.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
bioanalysisDMPKclinical pharmacologypopulation PK modelsLC-MS/MS assay validationregulatory guidancePK principlesdata deliverysample analysisassay validation
Soft Skills
effective communicationcollaborationorganizational skillsvendor managementproactive mindsetflexibilityteam-oriented approachability to thrive in dynamic environmentsinfluence without authorityresourcefulness
Certifications
PhDPharmDMS