Job Openings
Clinical Pharmacology Director - REMOTE
About the job Clinical Pharmacology Director - REMOTE
About the job
- Provide clinical pharmacology support for programs through the worldwide marketing application filing, including supportive registration documents and presentations.
- Review and prepare documents for regulatory submission, including clinical development plans, Investigators Brochure, and the Clinical Pharmacology section of INDs, CTAs, and/or NDAs.
- Contribute to the clinical pharmacology sections of regulatory documents, including Investigator Brochures, documents for regulatory meetings, NDA/BLA/MAA.
- Participate in designing the overall clinical pharmacology plan for the different steps of clinical development, according to the strategy developed by the Company.
- Write and review scientific documents, such as Clinical Study Protocols, Standard Operating Procedures (SOPs), Statistical Analysis Plans, and Clinical Study Reports
- Collaborate with cross-functional teams, including clinical, clinical operations, regulatory affairs, and biostatistics, to ensure the successful execution of clinical trials
- Ensure the successful preparation and presentation of all internal and external documentation relating to clinical pharmacology.
- Development and execution of clinical pharmacology strategies for late-stage development programs from Proof-of-Concept (Phase 2a) through worldwide marketing application.
- Oversee population PK, ER, c-QTc analyses conducted by the vendors and perform PK NCA analysis/fit-for-purpose PK/PD simulation if needed.
- Provide expert PK/PD advice to cross-function project teams.
- Advanced degree (PhD, PharmD, MSc) in Pharmacology, Pharmaceutical Sciences, or related field.
- Minimum of 5 years of experience in clinical pharmacology in the pharmaceutical industry.
- Strong knowledge of PK/PD principles and their application to clinical pharmacology.
- Familiarity with PK/PD software (e.g. WinNonlin, NONMEM, Monolix, R, etc) and working knowledge of MIDD concepts.
- Experience in oncology small molecule development is preferred.
- Experience in regulatory submissions and interactions with regulatory agencies.
- Experience in clinical pharmacology study design and interpretation.
- Experience in clinical pharmacology data analysis and reporting.
- Excellent written and verbal communication skills.
- Ability to work independently and as part of a team.
Please use the below link for job application and quicker response:
https://lifelancer.com/jobs/view/fcd11ffd1d32c21e6195655caea78ab6