About Codera
Codera is a Tang Capital company that provides in-house end-to-end drug development capabilities for its portfolio companies. Founded in 2002, Tang Capital is a life-sciences focused investment company that creates, acquires and finances companies that develop and commercialize pharmaceutical products.
Position Summary
The Associate Director/Director, Clinical Pharmacology will contribute to the oversight, planning and execution of clinical pharmacology strategy in support of Codera's development programs. In collaboration with internal departments, such as safety, biometrics, clinical operations and regulatory, the Associate Director/Director, Clinical Pharmacology will contribute to all aspects of clinical pharmacology, including design of clinical studies, analysis of pharmacokinetic (PK) data, oversight of vendors and production of regulatory and clinical documents.
Essential Duties and Responsibilities
- Assist with the design and execution of clinical pharmacology studies, including overall study planning, preparation, management, evaluation and documentation
- Contribute to clinical pharmacology strategy and regulatory packages
- Manage relationships with various bioanalytical labs and other contract research organizations (CROs)
- Prepare, analyze and interpret PK data to produce reports that integrate into clinical and regulatory documents
- Draft, edit and review sections of regulatory submissions and clinical documents
- Provide scientific input for protocols, statistical analysis plans and study reports
- Research clinical pharmacology topics to support Tang Capital's investments
- Participate in business development activities, as requested
Qualifications
- Bachelor's degree or higher in life sciences or related discipline required
- Master's degree preferred
- Minimum of 5 years in relevant pharmaceutical industry work experience required
- Experience with clinical pharmacology and PK-centric studies, including food effect studies, drug-drug interactions studies, ascending dose studies and bioequivalence studies required
- Experience working with bioanalytical labs
- Experience calculating PK parameters using software programs like Phoenix WinNonlin
- Experience writing and/or reviewing regulatory and clinical documents, including IND/NDA sections, protocols and clinical study reports
- Ability to effectively organize and manage multiple assignments with challenging timelines from project start-up through submission
- Knowledge of FDA and ICH regulations
- Outstanding written and verbal communication skills, including the ability to use clear language to explain complex ideas
- Ability to establish and maintain collaborative working relationships with internal and external stakeholders
Codera, LLC is an equal opportunity employer. Codera, LLC participates in E-verify.