Director, Clinical Pharmacology & DMPK

About us:

Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. Our lead program is a next-generation myosin inhibitor, licensed from Hengrui Pharma, being developed to transform the treatment of hypertrophic cardiomyopathy (HCM)—the most common inherited cardiac disease.

Currently in Phase 3 clinical development in China for the more common obstructive form of HCM, our candidate has demonstrated a compelling clinical profile that may position it as a best-in-class therapy with meaningful differentiation.

With a proven leadership team, a strong financial foundation, and a high-value late-stage asset, Braveheart Bio represents an outstanding opportunity for ambitious, mission-driven professionals to make a tangible impact in a high-profile and rapidly evolving therapeutic area.

The role:

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. 

Key responsibilities:

Scientific & Clinical Expertise 

• 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. 

Strategic Program Leadership 

• 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. 

Cross-Functional Impact 

• 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). 

Operational Strength 

• 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. 

Leadership & Startup Fit 

• 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. 

Required experience & skills:

• 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 experience & skills:

• 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 

Base Salary Range: $208,000 - $265,000

We are an equal opportunity employer. 

We are committed to inclusion and diversity, and we do not discriminate on the basis of race, gender, religion, gender, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any characteristic protected under applicable law.