The Manager, Data & Analytics leads the strategy, development, and delivery of commercial analytics capabilities to turn complex data into actionable insights. They are responsible for managing analytical workstreams, defining KPIs, and collaborating with cross-functional teams to improve commercial effectiveness.
The Director will lead the regulatory review and approval of promotional materials, medical communications, and social media content to ensure compliance with FDA standards. They will serve as the primary point of contact for the FDA's OPDP/APLB and provide strategic regulatory guidance to cross-functional teams.
The Director will lead outsourced drug product development and manufacturing activities, serving as the primary technical lead for CDMO partners. They are responsible for overseeing formulation, process validation, technology transfer, and commercial supply readiness while ensuring alignment with regulatory and quality standards.
The Senior CSV Analyst will lead and support validation activities for GxP computerized systems using a risk-based CSA approach. They will also manage inspection readiness activities, including gap assessments, documentation preparation, and supporting regulatory audits.
The Associate Director will serve as the study lead programmer for clinical trials, overseeing vendor deliverables and ensuring high-quality data standards. They will collaborate with biostatisticians and data management teams to support clinical trial data review, analysis, and regulatory submissions.
Implement market access strategies for assigned commercial payer and PBM accounts, manage executive relationships, and develop account-specific access and reimbursement recommendations. Lead account planning and customer engagement, translate clinical and economic evidence into payer-relevant discussions, and provide market insights to support launch readiness and leadership decisions.
The Staff Accountant will manage accounts payable processes, including invoice review and weekly payments, while assisting with general ledger accounting and month-end close activities. The role also involves supporting bank reconciliations, maintaining accurate financial records, and ensuring compliance with internal controls.
The Director of Supply and Distribution Quality oversees outsourced commercial packaging, labeling, distribution, and serialization activities to ensure compliance with cGMP and DSCSA standards. This role manages relationships with CMOs, CPOs, and 3PLs while leading inspection readiness and risk-based quality governance.
The Director of Medical Communications will lead the development and execution of medical communication strategies to support the company's psychiatry portfolio. This role involves translating complex scientific evidence into impactful materials while managing cross-functional partnerships and external agency vendors.
The Director will own the development and execution of the Patient Services strategy to drive the successful commercial launch of DT120. This role involves designing end-to-end patient journeys, managing REMS compliance, and leading cross-functional teams to ensure operational success.
The Director will lead the end-to-end strategy, design, and execution of Expanded Access Programs and late-stage clinical studies. This role involves cross-functional collaboration to ensure programs are scientifically sound, compliant, and aligned with the company's overall asset strategy.
The Senior Director will lead the commercial finance function, serving as a key business partner to the commercial leadership team. Responsibilities include overseeing financial planning, revenue forecasting, launch readiness, and establishing infrastructure to support the company's commercialization efforts.
The MSL will build and maintain relationships with Key Opinion Leaders and healthcare providers to communicate scientific data regarding the psychiatry portfolio. They will gather clinical insights from the field to inform internal R&D strategies and support clinical trial initiatives.
The MSL will build and maintain relationships with Key Opinion Leaders and healthcare providers to communicate scientific data regarding the psychiatry portfolio. They will gather clinical insights from the field to inform internal R&D strategies and support clinical trial initiatives.
The MSL will build and maintain relationships with Key Opinion Leaders and healthcare providers to communicate scientific data regarding the psychiatry portfolio. They will gather clinical insights from the field to inform internal R&D strategies and support clinical trial initiatives.
The Senior MSL serves as a field-based scientific expert building relationships with KOLs and stakeholders to communicate scientific data for the psychiatry portfolio. They also support government affairs, HEOR, and the development of internal medical affairs infrastructure.
The Senior MSL serves as a field-based expert building relationships with KOLs and stakeholders to communicate scientific data for a psychiatry portfolio. The role also involves gathering field insights to inform R&D strategy and supporting government affairs and HEOR initiatives.
Serve as a field-based scientific expert building relationships with KOLs and stakeholders to communicate scientific data for the psychiatry portfolio. Support medical affairs infrastructure, government affairs, and clinical trial initiatives to align R&D with real-world practice.
The Senior Director will provide clinical science leadership, managing the design, planning, and execution of clinical trial programs with minimal guidance, and leading study design, implementation, and execution for assigned programs. This role involves serving as a major contributor to protocols, data interpretation, final reports, and overseeing medical monitoring activities for all human clinical trials.
