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Job Title: Director, Clinical Pharmacology & Pharmacometrics
Reporting To: Vice President, Head of Clinical Pharmacology & Pharmacometrics
Department: R&D: Clinical
People Manager: No
Location: San Diego, hybrid schedule in office 3 days a week
Position Summary
The Director, Clinical Pharmacology & Pharmacometrics (CPP), will be a key member of the Clinical Pharmacology group and will report directly to the VP of Clinical Pharmacology. This individual will apply strong clinical pharmacology skills to independently determine, plan and execute clinical pharmacology strategy along with modeling/simulation analyses as applicable for a successful product registration
Responsibilities Include But May Not Be Limited To
• Serve as a core member of cross-functional drug development teams
• Design, execute, interpret data from various clinical pharmacology studies (single ascending dose, multiple ascending dose, drug-drug interaction, food effect, 14C human ADME, bioavailability/bioequivalence, impairment etc.)
• Serve as the lead for clinical pharmacology and/or pharmacometrics deliverables, including population PK, PK-PD, exposure-response, model-based meta-analysis, trial simulation, etc.
• Participate in preparation of regulatory responses and submissions, interactions with health authorities as clinical pharmacology/pharmacometrics subject matter expert (SME)
• Collaborate with internal and external SMEs to develop and enhance pharmacometrics methodologies and capabilities
• Be responsible for guiding model-based efficacious dose prediction for First-In-Human studies by interpreting and integrating in vitro and in vivo data from nonclinical studies.
Minimum Requirements
• PhD degree in life sciences (e.g., biology, biochemistry, biophysics, or pharmacology), chemical engineering, pharmacokinetics, or related disciplines with 10 years relevant experience in understanding of drug development, PK/PD, systems pharmacology, and mathematical modeling
• 10 years of experience Pharmaceutical, Biotech experience, Regulatory and/or Academic experience in clinical pharmacology related applications
• Experience with development of small molecules required
• Experience with CNS drugs including epilepsy or rare disorders required
• Experience with pediatric development is a plus
• Demonstrated regulatory interactions (FDA/EMA etc.) as a Clin Pharm lead is a plus
• Expertise with modeling software such as Phoenix system, Sym-CYP , NONMEM, R etc.
• Experience with PBPK modeling is a plus
• A strong understanding of US and EU (at a minimum) and other international pharmaceutical guidelines and regulations is required, particularly ICH and GCP
• Excellent verbal, presentation, and written communication skills
• Demonstrated understanding of CMC, translational biomarkers, drug metabolism & transporters, pharmacokinetics, and drug development
• Ability to foster relationships within an organization and advance the concepts of model informed drug development (MIDD)
• Record of publications, presentations, and volunteering for professional organizations
About Longboard
At Longboard Pharmaceuticals, our mission is to enhance the lives of individuals battling profound neurological conditions. Collaboratively, we foster an inclusive company culture and an inviting environment that we take immense pride in. We actively seek dynamic, talented, and dedicated individuals to join our team.
Pay Transparency
The expected salary for candidates who work in La, Jolla, CA is $210,000.00 – $235,000.00. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the industry, education, etc. Longboard Pharmaceuticals, Inc is a multi-state employer and will consider candidates based in remote work locations.
Benefits
At Longboard, we prioritize the well-being and satisfaction of our employees, understanding that benefits play a crucial role in their overall compensation and life quality. We take pride in providing a robust suite of benefits designed to safeguard the health and happiness of our team members, their families, and their lifestyles.
Our Benefits Currently Include
• Hybrid work schedule out of our La Jolla office, 3 days a week
• Competitive compensation package including bonus opportunities and stock options
• Medical, Dental & Vision Plans
• 401(k) Plan, including company match with immediate vesting
• Flexible Time Off, including one week off in the summer and one week off around December holidays
• 11 paid company holidays per year
• An opportunity to do truly meaningful work to make a lasting impact
• Longboard Perks (on-site gym, garage parking, company-sponsored events, etc.)
• Flexible spending account for medical care
• Life insurance, short and long term disability plans
