Director, Clinical Pharmacology & DMPK

Braveheart Bio•San Francisco, CA

18d•$208,000 - $265,000

About The Position

The Director of Clinical Pharmacology and DMPK will lead all aspects of execution and oversight across nonclinical and clinical programs. This individual will serve as the primary liaison to external CROs, ensuring scientific quality, regulatory compliance, and timely delivery of data. This role will also partner cross functionally with CMC, Clinical Operations, and Regulatory to support advancement of our phase 3-ready asset. This is a hands-on, highly collaborative position that requires both technical depth and operational agility suited to a startup advancing toward pivotal studies.

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

Nice To Haves

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

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.