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 Contracts Operations Specialist will manage the contract lifecycle, including intake, tracking, and execution within the CLM system. They will also support legal operations by maintaining contract data, generating reports, and collaborating with cross-functional teams to optimize workflows.
The Patent Agent will manage and execute the company's intellectual property strategy, including drafting and prosecuting patent applications with the USPTO. They will collaborate with R&D and legal teams to monitor innovations and ensure alignment with business and regulatory objectives.
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 Associate Director will oversee the regulatory review and approval of promotional materials, medical communications, and social media content for assigned brands. They will serve as the primary liaison with the FDA's OPDP/APLB and ensure all promotional activities comply with regulatory standards and company policies.
The Associate Director will lead integrated project planning, milestone tracking, and cross-functional execution for drug development programs. They will also proactively manage risks, facilitate team meetings, and prepare decision-focused materials for leadership forums.
Lead a group of statistical programmers to deliver high-quality analysis datasets and integrated data packages for regulatory filings. Collaborate with biostatisticians and manage vendors to ensure accuracy and timeliness of clinical trial data analysis.
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.
Ensure GxP systems are implemented, validated, and maintained in compliance with regulatory and quality standards. Provide quality oversight for the software development lifecycle, including vendor evaluations and the approval of validation documentation.
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.
Oversee outsourced drug product development and manufacturing activities through CDMO partners from process development to commercial readiness. Lead secondary packaging development and ensure alignment of design, qualification, and regulatory expectations for late-stage products.
Develop and lead value demonstration and communication strategies to optimize patient access by engaging with healthcare decision-makers and influencers. Collaborate with internal functions to generate real-world evidence and support the operationalization of patient care sites.
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.
