Director/senior Director, Dmpk at BridgeBio Pharma, Inc. in San Francisco, CA

who you are:

Eidos is seeking an experienced and highly motivated Director of DMPK to provide expert guidance on clinical and non-clinical pharmacokinetics and clinical pharmacology. This position will be responsible for designing, implementing, and interpreting in vitro and in vivo studies to understand adsorption, distribution, metabolism, and excretion (ADME) to drive to development candidate optimization and progression into the clinic. The Director of DMPK will be accountable for establishing DMPK strategy and tactical planning along with in-house and external execution, outsourcing, monitoring, and reporting while ensuring high-data quality for regulatory submissions. This position will report to the Vice President of DMPK.

responsibilities:

• Provide expert guidance on all aspects of clinical and non-clinical pharmacokinetics and clinical pharmacology
• Write, review and edit relevant sections of regulatory submissions – IND, DSUR, NDA, etc., and respond to queries from regulatory agencies
• Design and oversee ADME and PK studies to support discovery and development programs
• Participate in study design, vendor selection, study execution, interpretation and report writing for molecules that pertain to PK and PK/PD assessment
• Contribute to design of human PK, ADME and DDI studies and write the protocol sections related to these study components
• Lead writing of scientific publications on relevant topics – abstracts, posters, oral presentations and manuscripts
• Work collaboratively with other groups on PK and PK/PD aspects of non-clinical studies
• Engage and manage CROs and consultants as required

qualifications:

• Ph.D. in Pharmaceutical Sciences, or related discipline with a focus on pharmacokinetics, ADME, and PK/PD modeling and simulation
• At least 10 years’ experience in PK study design, PK analysis, population PK analysis, PK/PD and PBPK modeling, human dose prediction and report writing
• Hands-on experience LC/MS/MS systems and using Phoenix WinNonlin preferred
• Experience with, and demonstrated ability to, manage CROs
• Working knowledge of regulatory guidance for PK analysis and clinical pharmacology
• Ability to collaborate and effectively lead cross-functionally and in a team setting
• Excellent interpersonal and written communication skills in English to communicate effectively with external collaborators and internal project teams
• Ability to multi-task in a fast-paced dynamic environment while demonstrating a positive attitude and good work ethics

what we offer:

• Patient Days, where we are fortunate enough to learn more about the lives we are looking to impact and a real exchange of ideas as to how we can improve our efforts
• A culture inspired by our values: put patients first; think independently, be radically transparent; every minute counts, and let the science speak
• Learning and development training to help employees be the best version of themselves
• Collaborative business environment
• Excellent compensation package (Base, Performance Bonus, Stock, RSU programs)
• Excellent benefits package
• Flexible PTO
• With office locations in San Francisco, Boston, New York, and Raleigh, there are ample cross-collaboration opportunities with other BridgeBio Pharma programs
• A fast-paced, data-driven, work environment with world-class R&D minds and capabilities
• Work with the most productive groups of R&D operators in the industry
• Partnerships with leading institutions
• A platform for meaningful scientific contributions to shine
• Commitment to Diversity & Inclusion – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels respected for who they are, empowered to contribute, inspired to lead, and supported in their efforts to do so