Senior Director, Nonclinical Drug Evaluation

The Senior Director of Nonclinical Drug Evaluation will be a key member of the TB Alliance’s Research and Development team and responsible for supporting and managing the translational science components of programs in preclinical discovery and development. In addition, she/he will play a supporting role in advancing clinical programs.

This position will report to the Senior Director Nonclinical Drug Discovery & Evaluation with a dotted line to the Chief Scientific Officer.

The Senior Director will be responsible for helping to create and implement the research and nonclinical development strategy of the TB Alliance. As a key member of the TB Alliance’s Research and Development team, the role will:

• Advise and support TB Alliance’s discovery and preclinical projects, ensuring timely and quality technical performance. Help develop and ensure science based cost-efficient methods for advancing drug discovery programs from hit generation through lead optimization to preclinical candidate drugs, and ultimately the filing of INDs.
• Provide scientific and technical leadership on ADME, DMPK, and PKPD/PBPK modeling across the portfolio, from preclinical research through clinical development.
• PBPK modeling — human dose prediction, DDI prediction, clinical trial simulation (PO and LAI; adult/juvenile/PRGLAC populations).
• Nonclinical PK/PD modeling & simulation.
• Preclinical efficacy modeling, leveraging internal/external datasets independent of CRO/partner interpretation to further our understanding of nonclinical models of TB disease and clinical TB disease.
• Lead nonclinical modeling and translational input into portfolio project selection and candidate progression decisions.
• Marshal appropriate cutting-edge technologies and current industry practices to drive forward programs including application of free drug concepts for PK, DDI, and pharmacodynamic endpoint analysis and prediction.
• Collaborate broadly and effectively throughout the TB Alliance discovery and development team to help drive and maximize the TB Alliance’s research and development activities.
• Contribute to INDs, IBs, and clinical-development documents with emphasis on ADME, DMPK, modeling, and clinical translation.
• Backup/surge capacity for clinical pharmacology/pharmacometrics (population PK/PD) when required.
• Represent the TB Alliance externally in scientific drug discovery and development communities and in meetings with regulatory bodies.
• Report progress towards research milestones to the Research and Development team, the Scientific Advisory Committee, the Head of Research, and TB Alliance management as needed.
• Ensure progress of portfolio projects by the efficient science based leverage of TB Alliance resources, including preparation of materials for interim and formal project reviews when appropriate.
• Contribute to TB Alliance’s research capabilities, particularly in building nonclinical modeling & simulation and translation science capability.
• Stay current on developments in ADME, DMPK, PKPD, TB biology and R&D in industry and academia.
• Ensure timely publication of research papers and maintain association with scientific and professional organizations to enhance the TB Alliance’s prestige.
• Responsible for compliance with applicable GxP regulations in performing the functions of the job and attendance at annual GxP or other applicable regulatory trainings provided by TB Alliance.

• A Ph.D. in a quantitative pharmacology discipline such as modeling and simulation, bioengineering, or a related discipline from a well-respected academic institution is required.
• 10+ Years of working experience in a research leadership capacity within a pharmaceutical/biotechnology company.
• Experience in mathematical modeling of…