Senior Director, Clinical Pharmacology

Clinical Dynamix, Inc.; South San Francisco (CA); Presencial; USD 200.000 - 260.000; Jornada completa

Descripción de la vacante

Clinical Dynamix, Inc. is seeking a highly motivated scientist to design clinical studies and perform PK/PD analyses. The role involves interpreting results and reporting findings to support drug development decisions and regulatory filings.

The candidate will lead PK/PD modeling efforts across Phase I–III and collaborate with multiple internal teams and external partners. The position reports to the SVP of Clinical Development and requires deep expertise in pharmacometrics, regulatory science,

Formación

• Ph.D. with 12+ years in Clinical Pharmacology or related field.
• Strong background interpreting non-clinical/clinical dose-response and PK/PD data.
• Regulatory guidance related to clinical pharmacology experience.
• Proficiency with PK/PD analysis software (WinNonlin, NONMEM, Phoenix NLME).

Responsabilidades

• Oversee and support a portfolio of clinical assets.
• Design Phase I studies and collaborate with clinical teams to select PK sampling strategies.
• Perform, supervise, and report PK and PK/PD analyses as assets progress through development.
• Integrate pharmacokinetic, pharmacodynamic, and safety data from multiple sources to optimize dosing.
• Interact with cross-functional teams to ensure timely study completion and regulatory filings.
• Contribute to protocol sections, analysis plans, and study reports for regulatory documents.

Conocimientos

PK/PD analysis

Regulatory guidance understanding

Independent leadership

Educación

Ph.D. in Pharmaceutics/Pharmacology/Pharmacokinetics or PharmD

Herramientas

WinNonlin

Phoenix NLME

NONMEM

Descripción del empleo

Position Overview

As Company continues to advance the development of our broad portfolio, we areseekingahighlymotivated scientist to be responsible for designing clinical studies and performing, interpreting, and reporting Pharmacokinetic/Pharmacodynamic (PK/PD) results.

Specifically, the incumbent will support the pipeline by constructing, validating, and implementing disease, placebo, exposure response, and appropriate PK/PD models to evaluate risk/benefit and facilitate drug development decisions.Basedonexperience,thispositioncouldserveasaClinicalPharmacology representativeon study and project teams and will contribute to the planning, implementation and organization of regulatory filings along with presentation of PK/PD data to internal cross-functional teams and external collaborators. Thispositionwillreport tothe SVPofClinical Development.

Responsibilities

Thesuccessfulcandidatemustbeabletoperformeachofthefollowingsatisfactorily:

• Oversee and support a portfolio of clinical assets
• DesignPhaseIstudiesandcollaboratewithclinicalteams (e.g. Clinical Operations, Research Bioanalytical scientists, Biometrics, and Clinical Development)to select the mostappropriatePK sampling strategy for Phase II-III studies
• Perform,supervise,andreportPKandPK/PDanalysesforCompany assetsastheyprogress through clinical development
• Capable of integrating pharmacokinetic, pharmacodynamic, and safety data from multiple sources to optimize dosing for patient populations across the development continuum will be essential
• Interact with scientists, medical directors, and Technical Operations /Regulatory Affairs personnel forthe timely completion ofclinical studies andregulatoryfilings
• Participate inmulti-disciplinarystudyteams andrepresent the function on project teams
• Contributeto protocol sections, analysis plans, study reports as well as regulatorydocuments (INDs, CTAs, NDAs, MAAs and Investigator's Brochure)
• Maintainandenhancetechnicalanddrugdevelopmentexpertise(e.g.,trainingcourses,external meeting attendance)
• Understand the legal and complianceenvironmentand drive collaborationwith the Legal and Compliance team
• Represent the Company Values in all interactions across allfunctions by supporting ateam approach to focus on our patients and customers as our top priorities

Requirements

Education and Experience

• Ph.D. degree or equivalent in Pharmaceutics, Pharmacology, Pharmacokinetics or PharmD with 12+ years of industry or equivalent experience in Clinical Pharmacology or similar background
• Strong theoretical background and hands-on experience interpreting non-clinical and clinical dose-response and PK/PD data to inform clinical study designs and drug development decision-making is required
• Neuroscience background strongly preferred
• Proficiency with analysis software (e.g., WinNonlin, Phoenix NLME, NONMEM, or other commonly used platforms) strongly preferred
• Prior experience in PK, PK/PD, and ADA of large molecules and/or vaccine therapeutics is preferred
• Knowledge and experience with regulatory guidance related to clinical pharmacology

Competencies and Attributes

• Ability to lead and work with others in a positive and collaborative manner
• Proven ability to work independently, proactively, and effectively
• Excellent oral and written communication skills and a proven track record of working effectively in a dynamic, integrated, team-oriented setting
• Learning agility and 'scalability' to take on increasing responsibility as Company grows
• Understanding the legal and compliance environment
• Ability to have fun and thrive in a growing, diverse and inclusive work environment