Lead and develop a high-performing rare disease sales team across the Carolinas, including recruiting and hiring Therapeutic Specialists, coaching employees, and driving compliant sales execution. Shape regional sales strategy, support product launches and portfolio selling, monitor team performance, and collaborate with commercial, medical, legal, compliance, market access, and patient services partners.
The intern will support the legal team's intellectual property strategy by conducting legal research on patent law and regulatory frameworks. They will also assist in monitoring legislative developments and preparing research memoranda for various stakeholders.
The Regional Director manages a team of Medical Science Liaisons to drive field medical strategy and ensure high-quality scientific engagement within the Central region. They are responsible for personnel leadership, performance coaching, and fostering collaboration between field teams and internal stakeholders.
The intern will work with senior biostatisticians on innovative statistical methodology and clinical trial analysis. They will also complete assigned goals that support the company's strategic business plan and present their work to the team.
The Executive Director will lead the global labeling, advertising, and promotion regulatory strategy to ensure compliance and scientific integrity across the product portfolio. They will serve as a strategic advisor to senior leadership while managing cross-functional teams and health authority interactions.
The Senior Manager will lead recruiting for assigned functional areas by shaping strategies and building talent pipelines to attract high-quality candidates. They will serve as a trusted advisor to business leaders and HR partners while driving operational excellence through data-driven recruiting processes.
Develop, implement, and maintain automated data analytics solutions to support clinical trial reporting and biometrics infrastructure. Collaborate with cross-functional stakeholders to identify technical gaps and deliver standardized, high-quality programming utilities.
Lead Field Medical Excellence initiatives by translating organizational priorities into an integrated roadmap, consistent planning frameworks, and scalable processes for field medical teams. Own designated CRM and enablement platforms, partner across functions on implementation and optimization, and use operational measures and field insights to improve execution and demonstrate medical impact.
The Director serves as the business owner for safety systems, defining the technology strategy, roadmap, and delivery for Drug Safety & Pharmacovigilance. They lead cross-functional collaboration to ensure systems are fit for purpose, compliant with global regulations, and integrated with enterprise data and AI initiatives.
The Senior Clinical Trial Manager oversees global phase I-IV clinical trials from startup through the Clinical Study Report, ensuring compliance with GCP and regulatory standards. They are responsible for managing study budgets, vendor relationships, project timelines, and mentoring clinical operations staff.
Formulate and implement global regulatory strategies to enable efficient product development for assigned programs. Serve as the primary regulatory contact for the US FDA and lead the preparation and submission of regulatory documentation.
The Associate Director, Programming will provide technical leadership as the Program Lead for an assigned compound, ensuring quality and timeliness of programming deliverables. They will collaborate with cross-functional teams and external vendors while overseeing contractors and coaching junior staff.
The Director of Biostatistics provides statistical leadership for clinical development plans and oversees the design, analysis, and reporting of clinical trials. They are responsible for managing CRO or internal teams, ensuring high-quality statistical output, and engaging with global regulatory agencies.
The Director, Medical Safety will lead a team of PV Scientists to oversee signal detection, risk management, and aggregate safety reporting throughout the product lifecycle. They will also serve as a strategic partner to cross-functional teams to ensure the timely identification and communication of product safety risks.
The intern will support the Clinical Development team by reviewing patient-level trial data and identifying trends or inconsistencies. They will also assist in data reconciliation, study tracking, and the preparation of materials for medical monitoring meetings.
The Senior Director will provide global regulatory leadership and strategic direction for assigned development programs across the product lifecycle. They are responsible for driving integrated global regulatory strategies and leading interactions with major Health Authorities like the FDA, EMA, and PMDA.
The Senior Director will lead global regulatory CMC strategy for gene therapy programs, ensuring compliance and efficient product development from early to late-stage. They will act as the regulatory lead at the CMC sub-team level, managing interactions with health authorities and overseeing the preparation of key regulatory dossiers.
The Associate Director will lead cross-functional initiatives to improve disease diagnosis experiences and manage the operational infrastructure for disease acceleration programs. This includes partnering with communication teams to drive awareness and overseeing agency relationships, budgets, and compliance documentation.
The CMC Lead will provide strategic and operational leadership for the development of gene therapy programs from early stages through commercialization. This role involves coordinating cross-functional activities across process development, manufacturing, quality, and regulatory teams while managing external CDMO/CRO partners.
The Therapeutic Specialist will develop and execute sales plans to maximize growth within the rare disease market while maintaining expert knowledge of the competitive landscape. They will collaborate with cross-functional partners and engage with healthcare professionals to achieve shared business objectives.
The Director, Medical Safety Lead serves as the subject matter expert for safety surveillance, risk management, and benefit-risk assessment for assigned gene therapy products. They are responsible for medical evaluation of adverse events, leading safety review teams, and providing expert input into regulatory and clinical development documentation.
The Senior Director will oversee the Drug Safety and Pharmacovigilance (DSPV) quality and compliance framework to ensure regulatory readiness and continuous improvement. They will lead compliance monitoring, manage quality events and CAPAs, and govern training and procedural standards across the PV system.
The Senior Manager, Clinical Supplier Quality leads supplier quality management activities for global clinical suppliers, ensuring compliance with regulatory requirements and internal quality standards. They manage supplier qualification, performance monitoring, risk assessments, and the development of Quality Technical Agreements to support clinical development programs.
The Associate Director will develop and maintain professional relationships with healthcare practitioners to provide comprehensive medical and scientific support across PAH, IPF, and PPF therapeutic areas. They will serve as a field-based expert, connecting HCP insights with internal research and commercial strategies while supporting clinical development programs.
The Associate Director will develop and maintain professional relationships with healthcare practitioners to provide comprehensive medical and scientific support across PAH, IPF, and PPF therapeutic areas. They will also serve as a field-based expert, translating clinical insights into actionable strategies while supporting clinical development and medical affairs initiatives.
The Associate Director will develop and maintain professional relationships with healthcare practitioners to provide comprehensive medical and scientific support for PAH, IPF, and PPF. They will also serve as a field-based expert, translating field insights into actionable strategies while collaborating with cross-functional teams.
The Associate Director will develop and maintain professional relationships with healthcare practitioners to provide medical and scientific support across PAH, IPF, and PPF therapeutic areas. They will also serve as a field-based expert, connecting clinical insights with internal research and commercial strategies.
The Associate Director will develop and maintain professional relationships with healthcare practitioners to provide medical and scientific support across PAH, IPF, and PPF therapeutic areas. They will serve as a field-based expert, translating clinical insights into strategy and supporting clinical development programs.
The Associate Director, Medical Science Liaison will develop and maintain professional relationships with healthcare practitioners to provide comprehensive medical and scientific support. They will also serve as a field-based expert, connecting healthcare professional insights with the company's research and commercial strategy.
The Associate Director will develop and maintain professional relationships with healthcare practitioners to provide comprehensive medical and scientific support across PAH, IPF, and PPF therapeutic areas. They will serve as a field-based expert, translating clinical insights into actionable strategies while collaborating with cross-functional teams.
