About the position
The Associate Director, Quantitative Pharmacology and Modeling & Simulation (M&S) is responsible for providing strategies, plans and deliverables on pharmacology and related quantitative analytics, for the advancement of programs across all stages of drug development at Dyne Therapeutics. Primary responsibilities include the strategic planning and execution of pharmacology- and biomarker-related modeling & simulation (M&S) activities in seamless coordination and collaboration with other internal functions and subject matter experts (SMEs), and the further implementation of an internal quantitative data analytics & modeling infrastructure in coordination with internal and external functional partners. The person in this role applies quantitative modeling, including pharmacometrics, modeling based on first principles (mechanistic PKPD, QSP, PBPK, etc), and data mining approaches, in support of objectives and progression of drug development programs, from preclinical inception to drug regulatory registration and approval. The person in this role works seamlessly with colleagues in the Translational Biomarkers & Pharmacology department and, with SMEs in platform discovery, preclinical research, clinical development, clinical operations, regulatory, CMC and program management, enabling IND submissions, initiation of clinical development programs, late-stage development, and interactions with Health Authorities. This role is based in Waltham, MA without the possibility of being a remote role.
Responsibilities
- Provide strategies and plans for quantitative data analytics (pharmacometrics, population PK/PD analyses, mechanistic drug-disease modeling, meta-analyses, data mining), in alignment with Regulatory requirements as well as corporate and R&D goals, thereby enabling the advancement of Dyne programs across all stages of drug development
- Provide expertise and guidance on quantitative aspects, including dosing strategies and PK/PD, to R&D program teams working alongside with Clinical Pharmacology and Biomarker Leads and in close collaboration with Medical, Biometrics, Pharmacovigilance, Preclinical Tox and ADME/DMPK SMEs.
- Provide hands-on quantitative data analyses, including PK/PD modeling and related tools, in support of program pipeline progression, from preclinical to clinical, and from early to late clinical development
- Lead the department in establishing a fit-for-purpose, internal PK/PD modeling workflow environment, from data inception to model building, model qualifying and model simulations, to enable PK/PD analyses internally while also interfacing with external modeling CROs
- Identify and manage consultants and vendors to support M&S activities
- Author high quality regulatory documents
- Accountable for adherence to agreed timelines and budgets to ensure execution of deliverables from Clinical Pharmacology studies and programs
- Collaborate cross functionally with all relevant areas to support corporate objectives
Requirements
- PhD, PharmD, or equivalent training in Quantitative Pharmacology, Pharmaceutical Sciences, Engineering, Physics, Applied Mathematics, and/or Computational Sciences, with 8+ years of bio/pharmaceutical industry drug development experience in Pharmacology- or Biomarker-related functions
- Strong understanding of Clinical Pharmacology principles, PK/PD modeling and simulation, the drug development process and regulatory guidance, particularly around oligonucleotides and biologics (including antibody-drug conjugates), molecular delivery systems, and rare diseases
- Hands-on skills in M&S and related infrastructure tools, including R, Monolix (or NONMEM), WinNonLin, data exploration & mining tools; experience in model-based meta-analyses desirable
- Experience with the preparation of Clinical Pharmacology portions of regulatory documents such as pre-IND, IND, IB, briefing documents, clinical study reports, CTA, and BLA
- Ability to devise innovative dosing strategies in a data-driven manner for novel classes of drug modalities
- 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
- Independent and highly motivated, with the ability to multi-task, drive strategy and execution, in a fast-paced and fluid collaborative environment
