Senior Director, Nonclinical Drug Evaluation

TB Alliance; New York (NY); On-site; USD 250,000 - 310,000; Full time

Benefits offered by this job

Hybrid schedule

Job summary

TB Alliance in New York City seeks Senior Director of Nonclinical Drug Evaluation to lead translational science for preclinical and early clinical programs. You will shape nonclinical strategy, provide leadership on ADME, DMPK, PKPD modeling, and contribute to IND/IB documents while ensuring regulatory compliance.

The role offers a hybrid schedule, competitive salary in the $250k–$310k range, and opportunities to advance TB drug development through world‑class science.

Qualifications

• PhD in a quantitative pharmacology discipline from a well‑respected academic institution is required.
• 10+ years of working experience in a research leadership capacity within a pharmaceutical/biotech company.
• Experience in mathematical modeling of biological processes including molecular, cellular, tissue and organism levels.
• Experience with popPK modeling and software tools for pharmacokinetic/pharmacodynamic modeling (e.g., NONMEM, R).
• Experience with PBPK modeling (e.g., simCYP) and nonclinical development requirements to move candidates to clinical trials.

Responsibilities

• Advise and support discovery and preclinical projects, developing cost-efficient methods for drug discovery from hit generation to IND filing.
• Provide scientific leadership on ADME, DMPK, PKPD/PBPK modeling across the portfolio.
• Lead nonclinical modeling and translational input into portfolio project selection and progression decisions.
• Represent TB Alliance externally in scientific communities and regulatory meetings.

Skills

Pharmacology modeling

PopPK modeling

PBPK modeling

Scientific leadership

Communication

Education

PhD in quantitative pharmacology

Tools

NONMEM

R

simCYP

Job description

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.

Position Responsibilities:

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.

Requirements:

• 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 biological process including molecular, cellular, tissue and organism levels.
• Experience with popPK modeling and the software tools for statistical, pharmacokinetic, and pharmacodynamic modeling of nonclinical and clinical data (e.g. NONMEM, R).
• Experience with physiological based PK modeling (PBPK) such as simCYP or similar commercial or academic software.
• Experience in nonclinical development with a thorough understanding of the requirements and processes needed to take a potential drug candidate from discovery into clinical trials.
• A successful track record in delivering drug candidates for development, preferably in the infectious disease area.
• A broad knowledge base in drug discovery and clinical development and experience with both discovery and development programs.
• Broad exposure to product development with an understanding of translational science and the complex interface between research and clinical development.
• Familiarity with regulatory guidelines governing the chemical, pharmacological, pharmacokinetic and toxicological aspects of a successful IND.
• Ability to interact in a positive manner with governments, funding agencies and the highest level of research management in pharmaceutical/ biotech companies.
• Ability to present well in an international setting and have the interest and ability to become an expert in TB.
• Strong communication, presentation and interpersonal skills with the ability to build effective working alliances.
• A sense of purpose and dedication to the mission of the TB Alliance and its not-for-profit focus.

Organizational Information:

TB Alliance is the recognized leader in accelerating the development and adoption of urgently needed new anti-tuberculosis (TB) drugs. The transformative BPaL/M regimens have become the gold standard for drug-resistant TB treatment, available at affordable pricing in more than 150 countries worldwide and approved by regulatory agencies in 28 countries.

TB continues to cause more deaths worldwide than any other infectious disease and disproportionately impacts marginalized populations as the disease is concentrated in lower- and middle-income countries and in patient populations in the lowest economic strata. The World Health Organization (WHO) reports an estimated patient population of 10 million annually with active TB, of which 410,000 have drug-resistant forms of the disease. In addition, over 1.5 billion people are infected with the TB bacillus, forming the reservoir for the development of active TB.

Despite the high degree of unmet need worldwide, lack of commercial viability severely limits commercial interest in this disease area and treatment improvements are largely dependent on financial subsidization through public sector and private sector funding. TB Alliance was established to fulfill the need for greatly improved TB treatment, deploying a unique not-for-profit operating model characterized by a small core of highly experienced internal staff with capabilities extending across the Research & Development spectrum through to achieving widespread access to improved TB drugs. The TB Alliance has a global footprint and an annual operating budget of approximately $100 million, including ~$45M in negotiated leverage funding.

Compensation and Benefits:

As part of our overall compensation package, we offer a competitive salary, comprehensive health benefits, generous retirement contributions, and work/life flexibility designed to support employees and their immediate family. Starting salary is expected to be in the range of US $250K – $310K exact salary will be commensurate with skills and experience and adjusted to reflect local currency for candidates outside the US.

Position based in New York City, NY (US). Other relevant locations may be considered. A flexible, hybrid schedule is available; domestic and international travel will be required.

TB Alliance is an Equal Employment Opportunity employer.This job description should not be construed to imply that these requirements are the only standards for the position. Other duties may be assigned. TB Alliance has the right to revise this job description at any time. TB Alliance is an “at will” employer and as such, neither this job description nor your signature constitutes any form of contractual arrangement between you and TB Alliance.