GlobeNewswire

Director

• Lead clinical pharmacology and pharmacometrics workstreams in CNS diseases (rare disease drug development experience preferred)
• Represent as therapeutic lead (siRNA or oligonucleotide experience is preferred) and SME in clinical pharmacology strategies, clinical study protocol preparation, study execution, data review/analysis, and study reports
• Lead the development and execution of translational and mechanistically based PK/PD modeling to enable identification of FIH dose, early characterization of efficacy and safety using biomarkers and disease animal models
• Lead and execute pharmacometrics strategies across all stages of drug development including population PK, PK/PD modeling and simulations, meta-analysis, disease modeling to inform clinical development
• Support non-clinical PK/PD, ADME and DMPK evaluations including strategy development, study design and execution, data analyses to inform lead optimization, candidate selection and nonclinical drug development
• Represent as functional lead for global regulatory activities and HA engagements (NDA and/or BLA experience is a must)
• Supervise, mentor and develop a team of high-performing scientists
• Contribute to platform-based pharmacology activities across novel genetic modalities and disease indications
• Encompass leading-edge knowledge in clinical pharmacology and pharmacometrics discipline, publish manuscripts
• Advocate scientific leadership at external conferences and scientific community.

Senior Director, Quantitative and Clinical Pharmacology

Compliance

• Serves as the subject matter expert for Regulatory Affairs Ad/Promo, providing leadership and development of innovative and compliant strategies to support communication and promotional objectives.
• Proactively identifies and evaluates fundamental issues, providing strategy and direction, anticipating factors that could influence strategies and company position in the market.
• Leads the PRC to navigate complicated claims while juggling requirements of laws and regulations, as well as interpreting and implementing FDA Guidance.
• Serves as lead Regulatory Advertising & Promotion expert on MRC.
• Accountable for review and approval of external communications materials for promotion and scientific exchange, and corporate messaging in line with relevant goals and deliverables with a broad impact on the organization. When needed, delegates tasks effectively and appropriately to direct focus on strategic planning and execution.
• Proposes creative, effective, and compliant regulatory strategies and solutions to challenging promotional concepts that meet business objectives and minimize risk.
• Supports Commercial launch teams, participating in strategy discussions and extended team meetings to provide regulatory guidance and perspective on marketing strategies and promotion objectives and tactics.
• Provides promotional regulatory input on concepts and draft materials to ensure they are aligned with promotional regulations, corporate standards and policies and business objectives.
• Leads the development and implementation of guidelines and processes for the creation, review, approval and regulatory submission, where applicable, of external communications content.
• Acts as the recognized authority on regulatory advertising and promotion matters. Able to work independently and deal with division or corporate functions, or with external agencies.
• Serves as primary Regulatory Advertising & Promotion contact for Regulatory Agencies.
• Actively participates in labeling and global regulatory team meetings to ensure support for anticipated promotional messages and claims (aligned with marketing strategy) in clinical trial design and product labeling as it related to the use of study results in US and global promotion.
• Maintains current awareness of evolving FDA regulations and interpretations, FDA advisory letters, enforcement letters and policies issues affecting the pharmaceutical/biologics industry and communicates significant changes in FDA perspective to relevant stakeholders.
• Contributes to the development of departmental strategic initiatives to drive effective, compliant promotional regulatory review.

Executive Director, Regulatory Affairs, Advertising & Promotion

• Establish and lead the medical information function, including strategy, processes, and execution
• Establish scalable medical information infrastructure, including inquiry intake, documentation, and response workflows
• Oversee the implementation and training of the medical inquiry intake portal and call center vendors and manage relationships going forward
• Develop high-quality medical information response documents (standard response letters, FAQs, backgrounders) and maintain medical information content aligned with product labeling, clinical data, and evolving scientific evidence
• Lead and oversee Medical, Legal, and Regulatory (MLR) review
• Ensure responses are scientifically accurate, balanced, up-to-date, and compliant with regulation
• Ensure appropriate escalation and coordination of safety, quality, and off-label inquiries
• Analyze inquiry trends to identify knowledge gaps, unmet medical needs, and opportunities to inform medical strategy
• Monitor metrics and quality indicators to ensure continuous improvement and compliance

Senior Director, Medical Information

Operations

• Build field reporting and analytics capabilities from the ground up to support KAM performance and decision-making.
• Partner with field leadership to define KPIs and develop analytics and dashboards to track performance and impact.
• Design and lead a Quarterly Business Review (QBR) process to assess commercial effectiveness and outcomes.
• Spend time in the field to understand Dyne’s operating model and translate insights into practical, field-ready solutions.
• Own KAM performance analytics and execution in support of incentive compensation programs.
• Collaborate with the KAM team to design and implement an account planning tool.
• Develop regional and account-level performance dashboards.
• Recommend and drive enhancements to BI and CRM tools to improve KAM effectiveness.
• Serve as the primary point of contact for the VP, Customer Experience, KAM leadership, and the KAM field team.
• Lead field force sizing and structural planning for upcoming launches and ongoing strategic reviews.
• Establish and maintain territory alignment and adjustment processes.
• Lead account and HCP targeting strategy and analytics in partnership with the Data and Advanced Analytics teams.
• Optimize field enablement tools, materials, and processes to maximize field productivity.

Senior Director, Quantitative and Clinical Pharmacology

Executive Director, Regulatory Affairs, Advertising & Promotion

Senior Director, Medical Information

Director, US Field Effectiveness – Operations