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Senior Director,
Clinical Pharmacology
for
Senior Director, Clinical Pharmacology
Waltham, Massachusetts
The Senior Director of Clinical Pharmacology will provide leadership to the Clinical Pharmacology and Pharmacometrics team and be accountable for the overall strategy for determining the PK, PD, and immunogenicity properties of all programs at Dyne Therapeutics.
This individual should be able to efficiently and effectively synthesize data to produce a clinical pharmacology strategy for the programs at Dyne. The ideal candidate will have a strong knowledge of best practices in Clinical Pharmacology and Pharmacometrics, extensive experience in designing and executing clinical pharmacology studies, and a demonstrated ability to make data-driven decisions based on preclinical and clinical information. The person will also work very closely with team members in the bioanalytical and biomarker function. As a core member of cross-functional program teams the selected candidate will work in close collaboration with colleagues in discovery, research, clinical development, clinical operations, and project management contributing to multiple IND submissions, initiation of clinical development programs, late-stage development, and interactions with health authorities.
Position Responsibilities
- Provide leadership to the Clinical Pharmacology and Pharmacometrics team and be accountable for the overall strategy for determining the PK, PD, and immunogenicity properties of all programs at Dyne Therapeutics
- Collaborate with colleagues in discovery, research, clinical development, clinical operations, and project management contributing to multiple IND submissions, initiation of clinical development programs, late-stage development, and interactions with health authorities
- Lead the Clinical Pharmacology function and strategy, with a vision to create scientifically sound, innovative, and efficient programs that meet regulatory requirements, as well as corporate and R&D program goals, enabling advancement of Dyne programs across all stages of drug development
- Lead the Clinical Pharmacology accountability for Dyne portfolio from IND to post-approval, including design and implementation of program specific clinical pharmacology studies, data analysis, internal decision points, and external regulatory interactions
- Represent Translational Biomarkers SME providing expertise and guidance on PK/PD and clinical pharmacology on discovery and program teams
- Integrate clinical pharmacology knowledge with a broad understanding of and collaboration with related disciplines such as clinical development, biostats, regulatory, nonclinical and research to support and impact development decisions
- Develop clinical pharmacology plans to support the development and registration of Dyne programs
- Responsible for protocol design of clinical pharmacology trials, study planning, review, data analysis / interpretation, and reporting of individual studies implemented to support clinical pharmacology components of project plans
- Determine scope, design, and planning and analysis of pharmacokinetic (PK) and pharmacodynamic (PD) studies, and modeling/simulations required from a drug development and regulatory perspective to take a project from concept to NDA submission
- Lead and prepare appropriate documents or sections of clinical protocols, clinical study reports with respect to Clinical Pharmacology studies or data
- Author regulatory documents (IND's, NDA's, IB's, etc.) and respond to regulatory inquiries related to DMPK, PK/PD, and clinical pharmacology
- Identify and manage consultants and vendors and monitor work with external vendors to ensure compliance with agreed protocols, quality standards and timelines
- Ensure that appropriate PK, PD and PK/PD data analyses (including population PK, PK/PD modeling and simulation) are conducted for each study/program while adhering to timelines and budgets to insure prompt and accurate execution of deliverables from clinical pharmacology studies and programs
- Collaborate cross functionally with all relevant areas to support corporate objectives
Basic Requirements
- PhD, PharmD, 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
- This individual should be able to efficiently and effectively synthesize data to produce a clinical pharmacology strategy for the programs at Dyne. The ideal candidate will have a strong knowledge of best practices in Clinical Pharmacology and Pharmacometrics, extensive experience in designing and executing clinical pharmacology studies, and a demonstrated ability to make data-driven decisions based on preclinical and clinical information
- Strong knowledge of pharmacokinetics and pharmacodynamics principles, immunogenicity, modeling and simulation, Model-Informed Drug Development, ADME Concepts, and regulatory and clinical pharmacology requirements to support clinical development and regulatory submission
- Demonstrated track record and ability to manage the clinical pharmacology/ pharmacokinetic components of programs in clinical stage of development
- Experienced in performing Modeling and Simulation (M&S) in drug development (i.e. PK/PD, PBPK, mechanistic modeling, population PK)
- Proficient and experienced in using common PK/PD modeling software packages (i.e., Phoenix WinNonlin, NONMEM, R, SAS, and other similar tools)
- Experienced in preparing Clinical Pharmacology portions of regulatory documents such as the pre-IND, IND, IB, briefing documents, clinical study reports, CTA, and BLA submission documents
- Ability to innovate dosing strategies in a data-driven manner for this novel class of molecule
- Strong interpersonal and relationship building skills with demonstrated experience to lead and influence within a matrixed environment
- Ability to work and communicate in an open and clear manner, listening effectively and inviting responses and discussions with internal and external partners
- Must be independent and highly motivated, with the ability to multi-task, driving strategy and execution, in a fast-paced collaborative environment
Know About
Dyne Therapeutics
Dyne’s sole focus is to deliver transformative therapies for serious muscle diseases. Using our proprietary FORCE™ platform, we aim to overcome tissue delivery limitations and advance oligonucleotide therapeutics. Our team, with expertise in muscle disease, rare disorders, and drug development, along with a distinguished scientific advisory board, is committed to this mission.
Force Platform
Dyne’s proprietary FORCE platform drives the development of targeted oligonucleotide therapeutics, offering life-changing potential for patients with severe muscle diseases. Designed with deep expertise in muscle biology and oligonucleotide therapeutics, FORCE overcomes delivery limitations to muscle tissue, focusing initially on myotonic dystrophy type 1 (DM1),
Duchenne muscular dystrophy (DMD), and facioscapulohumeral muscular dystrophy (FSHD).
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