Senior Manager Clinical Pharmacology
This position is a key member of the development team, executing early clinical drug development activities evaluating the clinical pharmacology of antibody therapeutics focused primarily, but not exclusively, on immune-inflammatory diseases. This position reports to the head of clinical pharmacology and liaises with clinical development, clinical operations, non-clinical pharmacology and toxicology, and drug discovery to execute activities for advancing the development pipeline.
- Participate in the design of clinical pharmacology strategy 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/BLA/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 toxicokinetic and immnunogenicity 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/ADA/Biomarker samples are well managed
- Review clinical study protocols to ensure PK, ADA 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
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 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
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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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.
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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 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.Requirements
Education & Experience:
- PhD, PharmD or equivalent in Pharmacokinetics, Pharmacology, Bioanalytical or related field with at least 3+ years of experience in Clinical Pharmacology, DMPK or related disciplines required.
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.