Job Title: Head of Clinical Pharmacology
Job Number: 25070
Location: Cambridge, MA
The Head, Clinical Pharmacology will be responsible for the design, leadership, and implementation of Clinical Pharmacology strategies across Magenta’s research and development programs. This position will report to the Senior Vice President of Translational Sciences. He/she should be familiar with current practices in the following areas: clinical pharmacology, DMPK, bioanalytical assays and pharmacometrics. He/she should have a strong knowledge of best regulatory practices, extensive experience designing and executing clinical pharmacology studies, and a demonstrated ability to make data-driven decisions based on pre-clinical and clinical information. This individual will work in close collaboration with colleagues in Clinical Development, Clinical Operations, Biostatistics, Translational Sciences, Bioanalysis, Project Management, Research, and Regulatory to execute the company’s overall development strategy, participate on cross-functional project teams, and contribute to interactions with global health authorities.
This role provides the rare opportunity for a growing professional to develop their skills through collaboration with the senior most levels of the organization, while making strategic and tactical impact on the things that matter most – driving our science to help patients.
• Leading the Clinical Pharmacology strategy with vision to create scientifically sound, innovative and efficient programs that meet regulatory requirements, corporate and R&D program goals, and facilitate expedient development from preclinical to Phase 1 and on to registration
• Independently representing Clinical Pharmacology as a member of program, nonclinical, and clinical trial working teams, and contribute to clinical development strategy, clinical trial design, clinical study protocols, executing and coordinating clinical trial conduct and finalizing clinical study reports
• Partnering with the discovery group and work with preclinical DMPK colleagues to optimize preclinical models and inform first in patient clinical dosing strategies
• Reviewing preclinical study reports, in conjunction with Pharmacology / DMPK and preparing submission documentation
• Identifying and managing consultants and vendors to support Clinical Pharmacology studies
• Accountable for adherence to agreed timelines and budgets to ensure execution of deliverables from Clinical Pharmacology studies and programs
• Collaborating cross functionally with all relevant areas to support corporate objectives
• Ph.D., Pharm.D. or equivalent training in pharmacokinetics, pharmaceutical sciences or related disciplines with at least 10 years of bio/pharmaceutical industry drug development experience in clinical pharmacology.
• Strong understanding of Clinical Pharmacology principles, the drug development process and regulatory guidance to support Clinical Pharmacology strategies
• Experience with preparation of the clinical pharmacology portions of regulatory documents such as the pre-IND, IND, IB, briefing documents, clinical study reports, CTA and filing documents, while working in collaboration with cross functional team
• Experience in regulatory submissions for small molecules, biologics and cell therapies preferred, with a focus on preclinical and clinical development global strategy and execution. Experience with cell therapies, small molecules, and ADC products a plus.
• Ability to exercise good judgement, problem-solving skills, strong analytical and organization skills; attention to detail required.