BridgeBio Pharma
The Director/Sr. Director of Clinical Pharmacology will lead clinical pharmacology strategy for biologics programs, focusing on nonclinical antibody therapeutics. This role involves guiding quantitative approaches, ensuring high-quality execution across nonclinical and clinical development, and collaborating cross-functionally in a fast-moving biotech environment.
Key Responsibilities
- • Develop and oversee clinical pharmacology strategy for biologics programs across all stages of development
- • Serve as the CP lead on nonclinical and clinical project teams, providing scientific input on study design, dose selection, PK/PD, and E-R
- • Lead first-in-human dose selection, PK/PD analyses, including NCA, PopPK/PD, and modeling/simulation
- • Collaborate with external CRO partners to deliver quantitative support for program decisions
- • Contribute and author CP content to protocols, SAPs, CSRs, and regulatory submissions (INDs, briefing packages, BLA sections)
- • Partner cross-functionally (Clinical, Regulatory, Stats, Translational, Nonclinical) to integrate CP into development plans
- • Establish and maintain CP standards, templates, and oversight of bioanalytical and modeling vendors
- • Present findings internally and externally with scientific meeting abstracts, posters, and manuscripts
Required
- • PhD, PharmD, or MD in Clinical Pharmacology, PK/PD, Pharmaceutical Sciences, or related field
- • 5–10+ years industry experience (Director) or 10+ years (Sr Director) applying CP in drug development
- • Direct experience with monoclonal antibodies/biologics, including immunogenicity and TMDD
- • In depth knowledge in contemporary PK, population PK, QSP modeling concepts, data analysis, and interpretation; demonstrated record in applying these concepts to support pre-clinical and clinical development programs
- • Proficiency with PK/PD, E-R, and PMx tools (e.g., WinNonlin, NONMEM/Monolix, R)
- • Strong understanding of bioanalytical guidance and GLP/GxP regulations and regulatory expectations for CP across IND through BLA/MAA
- • Previous experience working on INDs
- • Excellent communication, cross-functional collaboration, and leadership capabilities
- • Vendor management and experience working in fast-paced, matrixed biotech environments
Benefits & Perks
- • Market leading compensation
- • 401K with 100% employer match on first 3% & 50% on the next 2%
- • Employee stock purchase program
- • Pre-tax commuter benefits
- • Referral program with $2,500 award for hired referrals
- • Comprehensive health care with 100% premiums covered - no cost to you and dependents
- • Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
- • Hybrid work model - employees have the autonomy in where and how they do their work
- • Unlimited flexible paid time off - take the time that you need
- • Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
- • Flex spending accounts & company-provided group term life & disability
- • Subsidized lunch via Forkable on days worked from our office
- • People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
- • We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
- • We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities
Company Overview
Industry: Healthcare Technology
Company Size: 500-1,000 employees
Founded: 2015
Headquarters: San Francisco, CA
Company Links
Key Contacts
Contact information not available
About the Company
Leading healthcare technology company focused on improving patient outcomes through innovative digital solutions. We're transforming the way healthcare is delivered with cutting-edge technology and data-driven insights. Our platform serves over 10,000 healthcare professionals and has processed millions of patient interactions.
Recent News & Updates
Mavericks Wanted
When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on
In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.
Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma.
What You'll Do
BridgeBio is seeking an experienced Director/Sr. Director of Clinical Pharmacology to help grow our biologics pipeline, with a primary focus on nonclinical antibody therapeutics. This candidate will serve as the clinical pharmacology leader: shaping nonclinical and clinical strategy, guiding quantitative approaches, and ensuring high-quality execution across nonclinical and clinical development. This is a high-impact leadership role in a fast-moving biotech environment.
Responsibilities
- Develop and oversee clinical pharmacology strategy for biologics programs across all stages of development
- Serve as the CP lead on nonclinical and clinical project teams, providing scientific input on study design, dose selection, PK/PD, and E-R
- Lead first-in-human dose selection, PK/PD analyses, including NCA, PopPK/PD, and modeling/simulation
- Collaborate with external CRO partners to deliver quantitative support for program decisions
- Contribute and author CP content to protocols, SAPs, CSRs, and regulatory submissions (INDs, briefing packages, BLA sections)
- Partner cross-functionally (Clinical, Regulatory, Stats, Translational, Nonclinical) to integrate CP into development plans
- Establish and maintain CP standards, templates, and oversight of bioanalytical and modeling vendors
- Present findings internally and externally with scientific meeting abstracts, posters, and manuscripts
Where You'll Work
This is a hybrid role and requires in-office collaboration in our Palo Alto office.
Who You Are
- PhD, PharmD, or MD in Clinical Pharmacology, PK/PD, Pharmaceutical Sciences, or related field
- 5–10+ years industry experience (Director) or 10+ years (Sr Director) applying CP in drug development
- Direct experience with monoclonal antibodies/biologics, including immunogenicity and TMDD
- In depth knowledge in contemporary PK, population PK, QSP modeling concepts, data analysis, and interpretation; demonstrated record in applying these concepts to support pre-clinical and clinical development programs.Proficiency with PK/PD, E-R, and PMx tools (e.g., WinNonlin, NONMEM/Monolix, R).Strong understanding of bioanalytical guidance and GLP/GxP regulations and regulatory expectations for CP across IND through BLA/MAA
- Previous experience working on INDs
- Excellent communication, cross-functional collaboration, and leadership capabilities
- Vendor management and experience working in fast-paced, matrixed biotech environments
Rewarding Those Who Make the Mission Possible
We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.
Financial Benefits:
- Market leading compensation
- 401K with 100% employer match on first 3% & 50% on the next 2%
- Employee stock purchase program
- Pre-tax commuter benefits
- Referral program with $2,500 award for hired referrals
Health & Wellbeing:
- Comprehensive health care with 100% premiums covered - no cost to you and dependents
- Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
- Hybrid work model - employees have the autonomy in where and how they do their work
- Unlimited flexible paid time off - take the time that you need
- Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
- Flex spending accounts & company-provided group term life & disability
- Subsidized lunch via Forkable on days worked from our office
Skill Development & Career Paths:
- People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
- We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
- We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities
#LI-SG1
Keep track of your job search
Save personal notes for each job to track your thoughts, application status, and follow-ups.
Try for freeUpload your resume
Sign up to upload your resume and get AI-powered customization for job applications.
Sign up freePractice your interview
Get AI-powered mock interviews tailored to this Director/Sr. Director, Clinical Pharmacology role. Upload your resume and practice with real-time voice feedback.
Sign up to practice