The Clinical Pharmacology and DMPK (CPDMPK) department at Theravance Biopharma is seeking an experienced modeling and simulation (M&S) leader to support M&S activities across small molecule drug discovery and development projects. Primary responsibilities will be to develop and implement M&S strategies in cross functional drug discovery and development project teams in collaboration with colleagues in discovery biology, clinical pharmacology and DMPK, biostatistics, and clinical development. This leader will also be responsible for the overall direction and enhancement of M&S activities across the organization. The successful candidate will exhibit communication and interpersonal skills and exhibit a desire to work in a fast-paced, flexible and dynamic environment.
Duties and Responsibilities
1) Provide M&S Strategic and Tactical Input to Project Teams
• Develop and integrate M&S plans with preclinical and clinical studies
• Support clinical dose selection and optimal trial design
2) Responsible for Pharmacometric Analyses for preclinical and Phase 1 – Phase 4 clinical trials
• Perform population PK, PK/PD, PBPK, clinical trial simulations, or other model-based analyses as appropriate for the discovery or development stage of the project
• Effectively communicate the impact of M&S analysis to project teams and senior management
3) Strengthen Internal M&S Infrastructure
• Build and enhance internal capabilities
• Establish and broaden connections to key external M&S opinion leaders
Applicants should possess a PhD in pharmaceutical science, pharmacokinetics, PK/PD, clinical pharmacology, applied mathematics, biostatistics, engineering, or other quantitative discipline. Prior experience of ~ 10 or more years in the application of model-based methodologies in drug discovery or drug development is required. Applicants should be well-versed in current PK and PK/PD modeling practices and concepts. Hands-on experience with PK and PK/PD modeling packages is required (e.g. NONMEM, ADAPT, WinNonlin, SimCYP and/or GastroPlus, R, SAS, etc.). The successful applicant will have strong verbal and written communication skills and the ability to work in a collaborative environment. Prior experience with regulatory guidelines, expectations, and interaction with regulatory authorities is preferred.
No direct reports but the successful applicant will be anticipated to manage in a matrix-based environment.
The incumbent may be required to sit, stand and walk for extended periods of time. The incumbent may be required to climb, bend, lift, carry and kneel. Because of the volume of work performed by computer and telephone, the incumbent will spend a considerable amount of time looking at the computer monitors and using his/her hands to operate office equipment.