Braveheart Bio · 5 days ago
Director, Clinical Pharmacology & DMPK
United States
Full-time
Remote
Director/Executive
$208K/yr - $265K/yr
8+ years expBraveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. The Director of Clinical Pharmacology and DMPK will lead all aspects of execution and oversight across nonclinical and clinical programs, serving as the primary liaison to external CROs and ensuring scientific quality and regulatory compliance.
BiotechnologyLife ScienceTherapeutics
Hiring Manager
Erica Arkin
Responsibilities
Understanding of human PK/PD, exposure-response modeling, and dose-optimization strategies for Phase II/III and registration
Expertise in ADME and translational modeling strategies relevant to late-stage clinical development
Experience in designing and interpreting clinical pharmacology studies (DDI, QTc, food effects, hepatic/renal impairment)
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
Leadership of 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)
Management of modeling and simulation vendors/CROs
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
Qualification
Required
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
Preferred
Prior experience in cardiovascular or rare disease therapeutic area
Hands-on experience with model-informed drug development (MIDD) or exposure-response analysis
Track record of collaboration in small biotech or matrixed environments with limited infrastructure
Company
Braveheart Bio
Braveheart Bio is a clinical-stage biotechnology company focused on developing precision therapies in the cardiovascular disease space.
2-10 employees
Funding
Current Stage
Early StageTotal Funding
$185M2025-11-05Series A· $185M
Recent News
2026-01-06
2025-12-16
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