Post: Associate Director Pharmacokinetics and Clinical Pharmacology
Endo International plc is a global specialty healthcare company focused on improving patients’ lives while creating shareholder value. Endo develops, manufactures, markets, and distributes quality branded pharmaceutical, generic and device products through its operating companies. Endo has global headquarters in Dublin, Ireland and US headquarters in Malvern, PA. Learn more at www.endo.co
- Key Accountabilities:
In association with the Senior Director of Pharmacology, develop and execute the clinical pharmacology plans supporting new product development and life-cycle management operations.
- Provide plans for the evaluation of the safety, tolerability and pharmacology of Endo development/pipeline products. Develop plans, conduct and/or direct pharmacokinetic (PK, including popPK) and pharmacodynamic (PD) modelling and simulation.
- Develop and execute preliminary and adjunctive clinical pharmacology studies (i.e. drug interactions, special populations, and bioequivalence etc.) protocol preparation, site approval, data analysis, and reporting of results for worldwide registration.
- Clinical pharmacology & DMPK due-diligence evaluations and recommendations for potential in-licensing opportunities.
- Represent Pharmaceutical Sciences Dept. on project teams and provide guidance and recommendations to project teams on clinical DMPK/pharmacology studies, data and interpretation. Provide technical and professional leadership and input to other members of the organization through informal, project team and matrix reporting relationships.
- Respond to regulatory authority (e.g. FDA, Health Canada, EMEA) questions on Endo products as required. Represent Endo before Regulators in areas of clinical pharmacology and PK/PD. Authorship for modules 2.6.4, 2.6.5, 2.7.1 and 2.7.2 and contribution to other modules of CTD for IND, NDA and sNDA submissions.
Education and Experience:
- The position requires a PharmD or PhD in Drug Metabolism and Pharmacokinetics, or equivalent training, and a minimum of 8 years of experience in clinical drug development within the pharmaceutical industry.
- The Associate Director should possess a strong background in PK/PD theory and practice with hands-on population PK data analysis, PK/PD modeling and simulation.
- Working knowledge of clinical trial design and execution.
- Fully conversant with population PK methodology and PKPD modeling/simulation.
- Knowledgeable about current regulatory requirements for clinical pharmacology study designs/data analysis.
Skills and Abilities:
- Proficient in PK/PD data analysis methods including population methods of PK/PD data analysis (NLME, NONMEM, WinNonlin).
- Excellent written and verbal communication skills, ability to communicate effectively with people individually and groups; ability to communicate with technical and non-technical colleagues; experience establishing and maintaining effective relationships with leaders and peers.
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