Associate Director, Regulatory Affairs Advertising and Promotion Daiichi Sankyo, Inc.Associate Director, Regulatory Affairs Advertising and PromotionBasking Ridge, NJ$166,720–$250,080 / yearFull timeThe Associate Director, Regulatory Affairs Advertising and Promotion (RAAP) provides strategic and tactical regulatory support for U.S. promotional and selected non-promotional communications across assigned products, disease-state initiatives, and related external-facing materials within the Daiichi Sankyo portfolio. Partner with Medical, Legal, Compliance, Commercial, Clinical, Labeling, Public Affairs, Corporate Communications, Market Access, including alliance partners to support aligned, efficient, and compliant review of promotional materials.
Director, Global Regulatory Affairs (GRL) Daiichi Sankyo, Inc.Director, Global Regulatory Affairs (GRL)Basking Ridge, NJ$193,040–$289,560 / yearFull timeThe GRL represents Daiichi Sankyo's regulatory group in internal and external development project meetings, provides guidance to peers and cross-functional team members regarding strategic regulatory issues, and develops overall regulatory strategy with input from respective regional strategists for global Health Authority interactions. Serves as a leader of the Global Regulatory Team (GRT) and is responsible for strategic integration of regional strategies, including an understanding of CMC, supply chain and commercialization aspects to support Health Authority requirements.
Associate Director, Global Oncology Medical Affairs, Early Pipeline Daiichi Sankyo, Inc.Associate Director, Global Oncology Medical Affairs, Early PipelineBasking Ridge, NJ$171,120–$256,680 / yearFull timeThe Associate Director Global Medical Affairs Oncology (GMA), under the direction of the Senior Director, GMA Oncology (Global Medical Affairs team lead for compound), is responsible for assisting with defining compound/program medical strategies and for leading select medical affairs projects within a specific compound or indication. Provides medical leadership in interactions with key external stakeholders and lead Scientific Engagement activities such as planning advisory boards, managing individual stakeholder interactions and peer to peer discussions, congress engagement activities, and collation of insights for select indications related to the compound.
Head, Global Oncology Medical Affairs, Clinical Trial Management, Resources, Operations & Governance Daiichi Sankyo, Inc.Head, Global Oncology Medical Affairs, Clinical Trial Management, Resources, Operations & GovernanceBasking Ridge, NJ$271,500–$452,500 / yearFull timeEnsure all key internal stakeholders are aligned on the approach and the conduct of a global studies/programs that will be implemented in multi-regions (US, Europe, ASCA, Japan)- including Regional Medical, Regional Operations, Safety, Regulatory, Quality, Legal/Compliance, Clinical Supply Operations, Global Program Teams, GMAT Leads, GMA leadership. Responsible for primary data evidence generation delivery of GMA programs: Company Initiated studies (CIS), Non-Interventional Studies (NIS) and Expanded Access Programs (EAP) delivery across countries in Oncology Business Unit and other Regions.
Director, Global Oncology Medical Affairs, Early Pipeline Daiichi Sankyo, Inc.Director, Global Oncology Medical Affairs, Early PipelineBasking Ridge, NJ$210,640–$315,960 / yearFull timeThe Director Global Medical Affairs Oncology (GMA), ADC, under the direction of the Senior Director, GMA Oncology ADC (Global Medical Affairs team lead for compound), is responsible for assisting with defining compound/program medical strategies and for leading select medical affairs projects within a specific compound or indication. Provides medical leadership in interactions with key external stakeholders and lead Scientific Engagement activities such as planning advisory boards, managing individual stakeholder interactions and peer to peer discussions, congress engagement activities, and collation of insights for select indications related to the compound.
NewVice President, Medical Larimar TherapeuticsVice President, MedicalPhiladelphia, PAD.O.) required; neurology or cardiology background preferred; 10+ years of pharmaceutical industry experience with demonstrated progressive increase in management responsibilities; Prior experience in neurology and/or rare disease preferred; Experience with activities related to Medical Affairs a plus but not required; Track record of meaningful and substantial support of Phase 2 and Phase 3 studies, such as medical monitoring activities (data, coding, and protocol deviation review), contribution to and review of documents (protocols, informed consent forms, clinical study reports), and interactions with relevant external stakeholders (key opinion leaders, investigators, data monitoring committee); Proven excellent writing, presentation, communication, leadership, organization, and problem-solving skills; Established understanding of good clinical practices (GCP) and best practices related to evidence generation and scientific communications; Demonstrated appreciation of the needs and culture of a small company environment; Robust knowledge of clinical development, regulatory requirements, and healthcare compliance. Specific responsibilities include: Lead the medical guidance and support of clinical development programs, ensuring prompt, facilitative, and high value collaboration with Clinical Operations and the cross-functional study teams; In coordination with Statistics and Quantitative Sciences, review data and assist with interpretation of data from clinical studies; Partner with Safety and Pharmacovigilance to ensure provision of medical input as needed; Support Medical Affairs activities; Review and approve documents related to the clinical development program; Represent Medical at internal meetings and provide definitive guidance and direction; Supervise direct reports and external contractors; Ensure compliance with relevant regulatory law and guidance; Present medical and scientific information at study site visits and congresses; Represent Larimar Medical in engaging with external partners, regulatory bodies, and other external stakeholders; Perform other duties as appropriate at the direction of the Chief Medical Officer.
Associate Director, External Supplier QA GMP Daiichi Sankyo, Inc.Associate Director, External Supplier QA GMPBasking Ridge, NJ$153,600–$230,400 / yearFull timeCross-Functional Team Participation: Responsible for working with Quality Leaders in each operating site to influence and affect the necessary operations managed through the leadership teams and will partner closely with other Subject Matters Expert across all the Functional Units (Global ADC Team Members, Pharmaceutical Technology, QA-GMP and QA R&D functional areas, Regulatory Affairs – CMC, Pharmacovigilance, Medical Affairs and Supply Chain) to ensure compliant operations. Quality Management System (QMS): Ensures and support that a robust QMS is in place at CMOs with respect to the facility, equipment & lab instruments, engineering, maintenance, computerized systems and validation activities which complies with GMP guidelines such as ICH and PIC/s as well as FDA regulation requirements, industry best practices and will withstand regulatory inspections by regulatory authorities and regular audits.
Head of Quality Assurance, Drug Product, GMP QA Daiichi Sankyo, Inc.Head of Quality Assurance, Drug Product, GMP QABasking Ridge, NJ$226,275–$377,125 / yearFull timeAs a member of SLT/SMT, the role will provide oversight of manufacturing sites according to the product lifecycle, collaborate with Quality teams to complete PPQ planning and the transition to commercial manufacturing activities for the product portfolio, and provide technical expertise to their team of MSMQs. Resolve issues in internal and external manufacturing site quality performance escalated from MSMQs in collaboration and negotiation with Tech Unit Senior Leaders (L-2 Leaders) and other internal peer groups, and escalate issues to GMQ Head as necessary for resolution and approval.
Executive Director, Head of Clinical Supply Planning and Operations SCM Daiichi Sankyo, Inc.Executive Director, Head of Clinical Supply Planning and Operations SCMBasking Ridge, NJ$255,000–$425,000 / yearFull timeAdditionally, as the regional head of DSI (US) CSO, this position will 1) Oversee all the Clinical Supply Operation-related functions in DSI, 2) Ensure alignment between DSI-CSO and TECH Unit sub-functions (Project Lead (CMC), Regulatory Affairs CMC, Process Technology Research, Formulation Technology Research, and Analytical & Quality Evaluation Research), 3) Make the best effort to increase the total performance of the TECH Unit. Responsible for leading all Clinical Supply Operation (CSO)-related activities for oncology and specialty medicine drug candidates from early development to launch and life cycle management of products globally to achieve the business success of Daiichi Sankyo Group and managing the Global-CSO function from Daiichi Sankyo Inc. (DSI).
Director, Healthcare Compliance Aquestive Therapeutics Inc.Director, Healthcare ComplianceWarren, NJReporting to the Chief Legal Officer & Chief Compliance Officer, this position serves as the Company's primary healthcare compliance leader and strategic advisor to Commercial, Medical Affairs, Market Access, Patient Services, Regulatory Affairs, and other business functions. Key Internal Partners: Legal, Commercial, Medical Affairs, Market Access, Regulatory Affairs, Finance, Human Resources, Quality, Patient Services, and Executive Leadership.
NewSenior Manager, Clinical Quality Larimar TherapeuticsSenior Manager, Clinical QualityPhiladelphia, PAPosition Overview: The Senior Manager, Clinical Quality serves as the study-level quality leader for the clinical quality assurance program for a clinical-stage biotechnology company focused on developing innovative therapies for patients with rare diseases through novel cell-penetrating peptide technology. This highly visible, cross-functional role partners with Clinical Operations, TMF Management, Biostatistics, Data Management, Medical Affairs, and external service providers to ensure the quality and integrity of clinical trial activities throughout the product development lifecycle.
NewManager, Drug Product Manufacturing Larimar TherapeuticsManager, Drug Product ManufacturingPhiladelphia, PAThe successful candidate will provide technical leadership across drug product manufacturing, process validation, lifecycle management, and commercialization efforts while partnering closely with Technical Operations, MSAT, Quality, Regulatory Affairs, Supply Chain, Process Development, and external partners. Reporting to the Head of Drug Product, CMC Technical Operations, the Manager/Senior Manager, Drug Product Manufacturing is responsible for overseeing external manufacturing operations and technology transfer activities for lyophilized biologic drug products supporting clinical and commercial supply.
Director, PV QA DSI Daiichi Sankyo, Inc.Director, PV QA DSIBasking Ridge, NJ$184,240–$276,360 / yearFull timeThe role will participate in other PV QA projects, tasks, and initiatives as needed and as instructed, including but not limited to including planning and PV QA executing the Pharmacovigilance Quality Strategy Plan in alignment with the DSI business objectives, review of key REMS documents, Health Authority Commitments, Quality Event management, escalation process and the CAPA oversight across applicable functional areas. Lead the PV inspection management activities by ensuring readiness, compliance, and inspection preparedness for the respective regulatory inspections in alignment with regulatory and company strategy, including coordinating and supporting preparation of CSPV teams and active participation and management of these processes, specifically in the US.
NewAssociate Director, Quality (Validation and Data Integrity) Larimar TherapeuticsAssociate Director, Quality (Validation and Data Integrity)Philadelphia, PAThe responsibilities for the Associate Director/Director, Quality, Validation and Data Integrity may include, but are not limited to the following activities: Provide Quality oversight of Computer System Validation (CSV)/Computer Software Assurance (CSA) activities related to initial implementations, changes, periodic review, maintenance, and decommissioning of GxP systems. The management team, employees, and consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs, commercialization, and the development of manufacturing processes utilizing good manufacturing practices (GMPs).
NewAccount Management - Project Coordinator ECLAROAccount Management - Project CoordinatorLawrence Township, NJ$36.42–$38.63 / hourProject Coordination and Support: Assist with Client initiatives, which may include alliance management, portfolio strategy, biomarker initiatives, and clinical guidelines/pathways projects, including project documentation and stakeholder communications. Contract and Budget Coordination Support: Support Client team members in coordinating and finalizing project expenditures, purchase order creation, invoice processing, and related financial activities.
Associate, Global Compliance External Engagement Daiichi SankyoAssociate, Global Compliance External EngagementBasking Ridge, NJRemoteContractorConduct independent initial review (“first line review”) of all planned CBER requests originating from DSI Business Requestors to determine if they (1) require CBER review and (2) if proposed engagements comply with applicable healthcare laws/regulations, internal policy and procedure requirements. Interact directly and frequently with CBER Committee Reviewers, Local Country-level Reviewers, and Business Requestors to assist with questions related to the review of CBER submissions.
NewDirector of Strategy & Impact (Grants & Allocations) Jewish Federation of Greater PhiladelphiaDirector of Strategy & Impact (Grants & Allocations)Philadelphia, PAServe as primary liaison between S&I and other departments on all workflows, including but not limited to: FRD and S&I departments for grantmaking committees (JFRE, Weinberg, WOV) and philanthropic guidance for restricted gifts, including identifying funder priorities and community needs. Work with Chief Strategy & Impact Officer on strategic planning for the Strategy & Impact department, including working with the Director of Israel and Global Operations to align funding priorities, budget operations, and missions and lay leader travel, and restricted gift workflow.
NewSales Training Senior Manager/Director Aquestive Therapeutics Inc.Sales Training Senior Manager/DirectorWarren, NJAs a key member of the commercial organization, this individual will be responsible for building a comprehensive learning curriculum that equips sales leaders and specialty sales representatives with the knowledge, skills, and behaviors necessary for launch success and growth. The Director will partner closely with Sales, Marketing, Medical Affairs, Market Access, Legal, Regulatory, Compliance, and external partners to translate commercial strategy into effective, compliant, and measurable learning experiences.
NewSr. Director, Global Brand & Portfolio Management CSLSr. Director, Global Brand & Portfolio ManagementSummit, NJ$287,000–$352,000 / yearOversees and guides continued global launch planning for aTIVc, including maximizing the portfolio opportunity across Fluad and aTIVc, refining the launch sequencing strategy, advancing business cases for key investments, and leveraging the Glocal brand marketing model (global to local division of activities) to drive efficiencies. Working in close partnership with R&D and cross-functional stakeholders, the role ensures alignment from research through commercialization, advances high-value strategic investments, and drives portfolio decisions that maximize mid- to long-term growth, value creation, and public health impact.
Head of Commercial Operations Aquestive Therapeutics Inc.Head of Commercial OperationsWarren, NJGroup and project leadership (interaction with cross-functional partners, conflict resolution, and consensus-driving) and project management (planning, prioritization, objective setting, meeting management, and plan execution) with history of working and delivering on multiple projects simultaneously, with tight deadlines and changing priorities. Demonstrated leadership focused on driving results and building successful team culture, a record of people management/development accomplishment, experience leading teams and cross-functional projects, and strong interpersonal, communications and presentation skills.