The Clinical Development department at Molecular Templates is seeking a Head of Pharmacometrics with exceptional technical and leadership skills to develop and implement modeling and simulation strategies to advance development of novel oncology drug candidates (engineered toxin bodies) across various stages of preclinical and clinical development. This individual will be responsible for the development and implementation of modeling and simulation strategies to ensure that the appropriate dose, route, and schedule of ETB’s is delivered by integrating data from within the department and in collaboration with the Research and Development departments.
- Work in close collaboration with key stakeholders, including preclinical toxicology, clinical development, and tumor immunology to define and execute clinical pharmacology and M&S strategy for novel oncology drug candidates
- Represent the clinical pharmacology function on development project teams and take accountability for clinical pharmacology deliverables including sample schedule, collection, storage, analysis, and interpretation
- Conduct PK/PD and exposure-response analyses using pharmacostatistical and relevant state-of-the-art modeling and simulation techniques to support dose selection, trial design, Go/No-Go decisions, regulatory submission documents, and publications
- Provide subject matter expertise to inform decisions on key scientific questions
- Provide key guidance on regulatory strategies, and present data and interpretations in written and oral form to regulatory bodies to enable optimal clinical development and registration of novel drugs
- Manage relationships with all external vendors involved in PK sample collection and analysis
- Interface with clinical trial sites to train the site staff on appropriate sample collection and storage
- Mentor and supervise junior staff members, if required
- Represent MTEM in the external scientific environment, influencing partners and regulators in a positive way
- Actively participate in departmental leadership
- Build collaborative networks internal and external to the company to ensure rapid and successful development of novel drugs
- An advanced degree (PhD, MD, or PharmD) with eight+ (8) years of experience in Pharmacology, Pharmaceutical Sciences, Pharmacy, Biomedical Engineering, or other related fields
- Expertise in Quantitative Pharmacology and hands-on modeling and simulation skills using NONMEM, R, Simcyp, SAS, MATLAB and/or other modeling and simulation software
- Experience with advanced mechanistic PK/PD models, disease models, PBPK models, Quantitative System Pharmacology (QSP) models, clinical trial simulation is highly preferred
- Track record of working with health authorities and responding to regulatory questions
- Knowledge of global regulatory requirements and guidances on quantitative analyses
- Excellent interpersonal, verbal and written English communication skills and the ability to function in a highly matrixed team environment
- Previous record of impact on drug development through quantitative approaches with strong leadership skills and the ability to influence
- Substantial understanding of oncology or related field (e.g., inflammation, immunology)
- Experience with large molecule therapeutics is preferred
This position currently has no supervisory responsibilities. This position reports to the Chief Medical Officer.
Molecular Templates celebrates and supports our differences and is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, veteran status, disability, or any other legally protected characteristic.
MTEM is committed to providing reasonable accommodations for qualified individuals. If you need assistance with your application due to a disability, you may contact us at: firstname.lastname@example.org.
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