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Associate Director, Clinical Pharmacology and DMPK
3 months ago
Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.
This position is a key member of the development team, executing clinical drug development activities by evaluating the clinical pharmacology of antibody therapeutics in an excellent organization that focuses primarily, but not exclusively, on immune-inflammatory diseases.
This position reports to the head of clinical pharmacology and DMPK and liaises with clinical development, clinical operations, non-clinical pharmacology and toxicology, and drug discovery to execute activities for advancing the development pipeline.
Essential FunctionsParticipate in the design of clinical pharmacology strategies and studies to support clinical development programs
Contribute clinical pharmacology sections of clinical study protocols and reports and regulatory documents including Investigator Brochures, and NDA/IB/IMPDs
Conduct hands-on non-clinical and clinical data analysis, including non-compartmental, PK/PD and modeling analyses where applicable
Oversees the development and validation of quantitative in vivo assays to enable PK/PD characterization of therapeutic antibodies
Work with nonclinical Pharmacology and Toxicology to design, analyze and interpret PK./PD relationship and toxicokinetic data
Collaborate with the clinical operations, clinical development, biostatistics/data sciences, and cross-functional project teams
Work closely with bioanalysis CROs to ensure that all studies are performed in high quality and timely manner to meet program milestones and goals
Work with Clinical Operations to ensure clinical PK/PD/Biomarker samples are well managed
Review clinical study protocols to ensure PK, PD and Biomarker sampling time points are consistent with study design
Manage CRO activities and ensure Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) compliance
Identify, scope out and select new clinical pharmacology/bioanalysis vendors as needed
Work with internal legal and finance to execute service contracts with CRO labs
Possesses excellent communication skills to work efficiently with all stakeholders
Qualifications Requirments
PhD, PharmD or equivalent in Pharmacokinetics, Pharmacology, Bioanalytical or related field with at least 5+ years of experience in Clinical Pharmacology, DMPK or related disciplines required.
Knowledge and Competencies:
Knowledge of pharmacokinetics and pharmacodynamics (PK/PD) and DMPK principles
Familiarity with regulatory guidelines such as ICH, GLP and GCPs
Working knowledge of clinical pharmacology related software tools such as WinNonlin, NONMEM, SympCyp and/or R
Knowledge of small molecule bioanalytical assays used to support PK studies
Experience and knowledge in translational methodologies to advance molecules from preclinical to first-in-human studies
Knowledge of quantitative pharmacology, modeling and simulation or advanced data analysis
Excellent team skills and proven ability to work within multi-disciplinary teams to influence the overall direction of projects
Strong ability to prioritize daily work based on changing business requirements
Excellent ability to multi-task in a high-energy, dynamic environment
Self-motivated, independent, and results-oriented
Ability to work productively in a matrix environment, as a team contributor taking ownership of multiple projects
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus in order to read.
Work Environment
The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job, typically in an open office environment.
The noise level in the work environment is usually moderate.
May be required to travel by plane or car
This position requires working with biological and/or chemical hazards
Alumis Values
Elevate
Challenge
Nurture
This position is located in South San Francisco, CA. At this time we are not considering remote applicants.
The salary range for this position is $198,000 USD to $220,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company's compensation practices.
Alumis Inc. is an equal opportunity employer.
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