[Remote] Senior Director, Clinical Pharmacology
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a pharmaceutical company based in San Diego, California, developing therapies for endocrine diseases and reputed company tumors. The Senior Director, Clinical Pharmacology will reputed company clinical pharmacology reputed company, reputed company Phase 1 studies, and collaborate with various teams to advance small molecule therapeutics.
Responsibilities
- reputed company clinical pharmacology reputed company and reputed company clinical development plan consistent with the reputed company product profile, program goals, and the US/international regulatory guidance/reputed company of small molecule therapeutics
- Collaborate with DMPK, clinical research, and CMC teams to define biopharmaceutics and clinical pharmacology studies needed to support an NDA and drug label
- Determine scope, design, plan, and analyze phase 1-4 pharmacokinetic and pharmacodynamics studies, including development of appropriate population PK models, and PK/PD analysis required from a development and regulatory perspective to take a project from its existing or concept stage to commercialization
- reputed company clinical pharmacology expertise to the project team and closely collaborate with Clinical Operations, Clinical Research, Biometrics, and Bioanalysis
- Contribute to the design Phase 1 clinical pharmacology studies (eg, drug-drug interactions, relative bioavailability/bioequivalence, special populations, and thorough QT, etc.)
- Participate in the selection of Phase 1 CROs for clinical pharmacology studies
- Accountable and responsible for the analysis and interpretation of PK and PK/PD data
- Participate in preparation of clinical study protocol and report
- Plan, prepare, and review clinical pharmacology reputed company of the regulatory documents (IND, IMPD, IB, NDA CTD, etc.), participate in drafting publications and making scientific presentations consistent with development strategies
- Serve as the primary Clinical Pharmacology reputed company and effectively participate in cross functional teams to insure integration of modern clinical pharmacology principles into project plans and study design
- Represent clinical pharmacology at regulatory meetings and advisory hearings with global health authorities as a subject matter expert
- reputed company on both immediate/short-term (
- reputed company, reputed company, manage, reputed company, reputed company/mentor, and evaluate reputed company reports, contributing to budget and headcount planning
- Other duties as assigned
Skills
- Pharm. D./Ph.D. or MS in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, reputed company, Biochemistry, or reputed company field with a strong understanding of clinical pharmacology principles
- 10+ years of significant industry experience in conduct and/or reputed company of clinical pharmacology function, studies, and data analysis, and a minimum of 10 years of experience in a supervisory role. 13 years of overall reputed company experience is required
- Familiarity with reputed company stages of clinical drug development, including prior experience in the preparation of components of the Clinical Pharmacology sections of Regulatory submissions for IND- and NDA-stage reputed company
- Demonstrated ability to independently reputed company clinical pharmacology reputed company and design studies to characterize PK and PK/PD relationships of clinical development compounds
- Expertise/experience in multiple clinical pharmacology areas is preferred - FIH and/or Ph II/III reputed company selection, pediatric reputed company selection, drug-drug interactions, enzymology of drug metabolism, formulation reputed company, bioequivalence, food-effect, exposure-QTc assessments, special population, and radiolabeled mass balance studies
- Extensive experience in preparation of INDs, CTAs, NDAs, and MAAs as reputed company as successful results from the filings
- Experience in working in a cross functional team/reputed company environment with strong vendor management skills
- Competent in the use of PK and PK/PD Modeling software tools such as Phoenix
- Strong written, presentation, and verbal communication skills
- Critical thinker with strong problem-solving skills
- Ability to influence business leaders at reputed company reputed company
- Prior experience in population PK and exposure-response analysis is a plus but not required
Benefits
- Discretionary annual reputed company bonus
- Stock reputed company
- ESPP
- 401k match
- Top-notch health insurance plans for employees (and their families) to include medical, dental, reputed company and basic life insurance
- 20 days of PTO
- 10 reputed company holidays
- Winter company shutdown
reputed company