121 director clinical development jobs found in Frankfort

Job Summary The Associate Director, R&D HCP Engagement CoE is a critical change agent and system implementer responsible for designing the operating model and overseeing the execution of a unified, compliant, and exceptional service model for all Healthcare Professional (HCP) engagement and contracting within R&D. This role will seek to transform an inconsistent process into an audit-ready, "white glove" service, providing necessary direction to a direct report responsible for day-to-day execution. While initially focusing on Medical Affairs, the vision is to cover all R&D HCP engagement over time. This position reports into the Medical Excellence & Operations Vendor and Contracts Management Lead and directly manages the Manager, HCP Engagement Lead. This position will lead the transformation of how Otsuka plans, governs, and executes interactions with healthcare professionals; ensuring all engagements are conducted with the highest standards of integrity,...

Job Summary The Director, Nephrology & Immunology Publications Lead is responsible for leading the planning, development, and execution of the global medical publication strategy and publication deliverables for the Nephrology and Immunology therapeutic area. This role ensures the timely, accurate, and compliant communication of scientific and clinical data through congress abstracts, posters, manuscripts, and other peer-reviewed outputs. Serving as the functional lead for publication operations within the Nephrology & Immunology Medical Communications team, the Director partners closely with cross-functional stakeholders, including Clinical Development, Global Integrated Evidence & Innovation (GIE&I), Medical Strategy, Core Content, and external vendors, ensuring excellence and consistency in scientific communication across the portfolio. The position reports to the Senior Director, Nephrology & Immunology Medical Communications Lead and plays a key...

The Associate Director, Scientific Communications manages the execution of the core scientific and medical communications strategy for the relevant therapeutic area portfolio. This role is accountable for delivering operational results by overseeing the creation of core content assets and managing the global publications plan. This position provides guidance, coaching, and oversight to the Manager, Medical Core Content, ensuring all materials are developed with scientific accuracy, consistency, and compliance. This position reports directly to the Senior Director, CNS Medical Communications Lead. Key Responsibilities Include: Global Scientific Communication Strategy Manage and deliver a comprehensive, globally aligned medical communications strategy and tactical plan for the relevant therapeutic area portfolio, in partnership with the Senior Director, Medical Communications Lead, CNS Lead, and cross-functional teams (e.g., Global Integrated Evidence &...

The Director, External Expert Strategy & Engagement is a critical role responsible for defining, standardizing, and overseeing the company's global strategy for engaging a broad spectrum of external stakeholders. This includes Key Opinion Leaders (KOLs), Digital Opinion Leaders (DOLs), Payers/Access Stakeholders, Academic/Integrated Health Systems, Patients/Caregivers, and Patient Advocacy Groups. The role is accountable for establishing the governance, process clarity, and technological infrastructure necessary to ensure coordinated, high-value, and non-transactional interactions across all functional areas, distinguishing tactics based on the asset lifecycle stage (Early vs. In-line). This position reports directly to the Executive Director of External Engagement and Field Excellence. Job Description Key Responsibilities: Strategic Governance and Accountability Establish clear accountability and process ownership for all external expert engagement...

The National Director, Rare Disease is a senior leadership position accountable for setting the US strategy, operational oversight, and performance management of the Rare Disease Field Medical Affairs (FMA) team. This role manages the unique challenge of strategically deploying a small MSL team across a disparate rare disease presence (including PKU and ALS), ensuring effective scientific exchange, supporting identification for evidence generation needs, and collaboration with patient advocacy and policy teams to ensure strategy reflects patient perspectives. The Director is responsible for medical customer engagement, including the hiring, development, coaching, and strategic deployment of the Rare Disease MSLs (including the PKU and ALS MSLs). This position reports directly to the Rare Disease Medical Business Unit Lead. Job Description Key Responsibilities: Leadership and People Management Oversee the recruitment, on-boarding, training, and performance...

Job Summary The Medical Director, Rare Disease is a critical role responsible for shaping the strategic processes and planning for assets in across phases of development within the Rare Disease portfolio. This position manages the unique challenge of establishing an emerging portfolio, incorporating newly acquired assets, which requires significant scientific and strategic agility and a strong ability to balance competing priorities. This position reports directly to the Rare Disease Medical Business Unit (BU) Lead. Job Description Key Responsibilities Include: Medical Strategy & Narrative Provide key medical input into the initial development of the Target Reimbursable Product Profile as well as early development plans ensuring scientific consistency and alignment across functions (e.g., R&D, Clinical, Global Medical Affairs) Provide high-quality scientific/clinical input and review of early asset plans, ensuring content aligns with the...

Job Summary The Manager, HCP Engagement Lead is a dedicated execution role responsible for the day-to-day operation and administration of the R&D Healthcare Professional (HCP) engagement and contracting process. This position is the primary point of contact for internal stakeholders seeking to engage external experts and is accountable for ensuring all contracts, payments, and documentation are processed efficiently, compliantly, and in accordance with the CoE's established "white glove" service standards. This role supports the Associate Director in maintaining the integrity of the centralized system and achieving audit-readiness. This position reports directly to the Associate Director, R&D HCP Engagement Center of Excellence (CoE). Job Description Key Responsibilities Include: Operational Execution and Contract Management Execute the end-to-end HCP contracting workflow, including drafting agreements, securing internal approvals, and managing...

The Manager, Data Analytics is an important role within the Medical Excellence & Operations team within Global Medical Affairs. This role will serve as the data and analytics lead supporting operational excellence across the Global Medical Affairs organization. This role is responsible for collecting, analyzing, and translating data into actionable insights that inform medical strategy, field engagement, performance measurement and medical strategy. The Manager, Data Analytics will work closely with both Field Medical and Headquarters teams to understand business needs and system requirements, support development of analytical solutions and other projects to drive key business processes and decisions for the Medical Affairs function. This role reports into the Business Solutions & Analytics Lead who reports into the Executive Director, Medical Excellence and Operations. Job Description Key Responsibilities: Data Collection, Management and Governance...

Job Summary The Director, Medical Communications directs Leads and manages the execution of the global and US scientific communication for the global and US scientific communication strategy for the assigned Rare Disease therapeutic area and product portfolio. This includes directing the development and dissemination of core scientific and medical content within the Rare Disease portfolio (e.g., global slide decks, congress abstracts/presentations, publications, medical information, and medical education materials) to ensure scientific accuracy, consistency, and alignment with the overall Rare Disease Medical Affairs strategy. The role is a key leadership position within the Rare Disease Business Unit (BU) Medical Affairs team, engaging a small team of internal stakeholders, external experts, and the broader scientific community. The role reports directly into the Senior Director, Rare Disease Business Unit Lead. Job Description Key Responsibilities: Global...

Vaccine Account Managers (VAM) collaborate with Pfizer partners to grow appropriate use of Pfizer Vaccines and the overall immunization rates of organized customers by identifying shared objectives, aligning resources and deploying innovative solutions to achieve targeted clinical and business results. This is accomplished through identifying, prioritizing, and managing opportunities to affect access, immunization practices, programs, education, and processes that will increase the appropriate use of Pfizer vaccines. A VAM's primary focus is to ensure access to the Pfizer vaccine portfolio by leading contract negotiations with assigned customers and to improve immunization rates through the development of productive relationships with key decision makers. Areas of customer focus include but are not limited to administrative and decision making roles of all levels at integrated health systems, large hospital systems, health insurance plans, state departments of health, county/city...

Become a part of our caring community and help us put health first The Clinical Pharmacist Lead monitors drug development pipeline, and medical literature, while providing clinical support for internal stakeholders. Utilizes broad understanding of managed care and PBM knowledge to develop, and/or implement strategies and programs to mitigate cost trend and improve health outcomes. The Clinical Pharmacist Lead works on problems of diverse scope and complexity ranging from moderate to substantial. The Pharmacy Director, internally known as a Clinical Pharmacy Lead, plans, directs, and monitors all financial, operational, professional, and clinical activities for the purposes of pharmacy program development for our Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP) Michigan Medicare - Medicaid health plan. The individual leverages a broad understanding of managed care and pharmacy benefit management (PBM) to develop and implement strategies and programs that drive...

Job Description Aligning with the strategic goals of the GQ organization, the Sr. Director of Global Quality Solutions (GQS) is responsible for understanding and driving efficiency across Global Quality's processes and operations via automation and digitization; serving as an enabler of transformation across existing GQ systems, future processes and teams. The Sr. Director position will facilitate continuous improvement activities within GQ leading special pilots, prototypes, collaborations and projects to digitalize the Knowledge and Document management processes. The Sr. Director of GQS liaises with applicable business functions (i.e., Otsuka Data Sciences, Otsuka Information Technology, Applied Innovation and Process Improvement, etc.) to advance the digital transformation of the entire GQ workspace (across GXP) via the optimization of applicable systems and workflows, the adoption of automation, and the promotion of a GQ culture driven by state-of-the-art...

Job Description The Clinical Note AI Agent Product Management Leader will be responsible for defining and executing the global strategy for our rapidly expanding product - Clinical Note AI Agent. This role will drive product innovation and growth across multiple geographies and specialties, lead cross-functional collaboration, and ensure seamless integration with healthcare systems and key stakeholders, including government and reimbursement teams. This is a hands-on product management role with people responsibilities. Strategy & Leadership: Develop and own the product strategy for the Clinical Note AI Agent to drive continued growth and global expansion. Customer Value: Ensure the Clinical Note AI agent provides measurable business value across customer bases, including Emergency Departments, Inpatient settings, and 18+ specialties across the US, UK, Canada, and Australia. Government Engagement: Serve as the principal product manager for...

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Associate Director Regulatory Affairs. The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects. This position is expected to lead the development...

Job Summary Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: "Otsuka-people creating new products for better health worldwide." Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. As an Associate Director, Biostatistician, you will be a champion of Otsuka's culture and values and will be responsible for providing statistical expertise/input in the drug development including clinical development plan and regulatory submission strategy. This is a strategic and critical role in the development of protocols and statistical designs in different phases of the clinical trials leading to approval of drug products in different phases of the clinical trials. This position can be based in Princeton, New Jersey, or Rockville, Maryland. Remote arrangements can also be considered. Otsuka...

ROLE SUMMARY The Internal Medicine Field Medical Director is responsible for providing Antiviral therapeutic area/product expertise for the designated therapeutic area across a broad range of external medical stakeholders ("EMS") and initiatives in an assigned territory. ROLE RESPONSIBILITIES Plan and execute independent medical strategies and engagements for appropriate assigned external medical stakeholders within a territory, compliantly coordinating with other Pfizer colleagues as needed to achieve medical objectives Maintain required level of knowledge of relevant TA/disease states and Pfizer medicines, providing therapeutic area/product information to both internal and external stakeholders as needed Serve as a conduit and resource for Medical Information and external medical stakeholder insights, providing requested information to external medical stakeholders as allowed by Pfizer guidance and sharing external medical stakeholder viewpoints with...

ROLE SUMMARY The Internal Medicine Field Medical Director is responsible for providing Antiviral therapeutic area/product expertise for the designated therapeutic area across a broad range of external medical stakeholders ("EMS") and initiatives in assigned territory. ROLE RESPONSIBILITIES Plan and execute independent medical strategies and engagements for appropriate assigned external medical stakeholders within a territory, compliantly coordinating with other Pfizer colleagues as needed to achieve medical objectives Maintain required level of knowledge of relevant TA/disease states and Pfizer medicines, providing therapeutic area/product information to both internal and external stakeholders as needed Serve as a conduit and resource for Medical Information and external medical stakeholder insights, providing requested information to external medical stakeholders as allowed by Pfizer guidance and sharing external medical stakeholder viewpoints with...

The Senior Director Translational Medicine will be responsible for design, execution and reporting of First in Human (FIH), Translational Medicine (TM) and Proof of Concept (POC) studies and will work closely with Discovery, Preclinical, Biomarker, Genomics, Bioanalytical and Global Clinical Development teams to ensure efficient and scientific execution of early phase trials as well as development and execution of biomarker plans as well as identification and utilization of emerging biomarker and translational tools, new technologies and scientific capabilities in support of Otsuka's pipeline. The Senior Director TM works closely with Head of TM as well digital and diagnostics groups to support development of biomarkers throughout life cycle of Otsuka's compounds. The Senior Director TM will represent TM at cross functional teams to identify, introduce, and evaluate discovery assets and ensures incorporation of translational tools in early phase programs. Senior Director TM will...

The Senior Manager, Centers of Excellence (CoEs) is responsible for establishing, leading, and optimizing one or more prioritized CoEs within the Global Quality Operations organization-such as Inspection Readiness, Audit Effectiveness, or other strategic focus areas. This role drives execution of CoE initiatives, develops tools and frameworks, and delivers performance metrics and dashboards to support continuous improvement and operational excellence. The ideal candidate will have strong global collaboration skills and experience working across cross-functional teams in a matrixed environment. Key Responsibilities Centers of Excellence Leadership Lead the development and execution of one or more CoEs (e.g., Inspection Readiness, Audit Effectiveness) aligned with global quality priorities. Establish CoE charters, operating models, and governance structures to ensure clarity and accountability. Develop and maintain tools, templates, and guidance documents...

Job Description Description NetSuite Project Manager - ERP Why NetSuite? One word - transformation . At NetSuite, we believe the cloud is here to stay, and so do our 20,000+ customers. We believe businesses should not be bogged down by the overhead of bulky data centers and expensive personnel to run it all. Businesses need to be lean, efficient, and agile. NetSuite is truly redefining business worldwide by providing a cloud-based, unified system that delivers unprecedented capabilities to drive the business forward. Founded in 1998 as THE cloud ERP pioneer, today NetSuite has transformed the business operations of our customers without the high costs and inefficiency of on-premise systems. Transform your career at NetSuite At NetSuite, we work hard. We hire steadfast competitors. We hire individuals that are daring trailblazers. NetSuite employees take the hill, we prefer action over inaction, we are dedicated in our mission, and we pause only to...

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. Job Overview We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Manager, Clinical Records Management. The Manager, Clinical Records Management will work in Clinical Operations under the leadership of Clinical Records Lead or similar, playing a pivotal role in supporting all aspects of central records for clinical studies across Phase 1-4. The Manager,...

Job Description The Brand & Product Communications Manager, Events & Experiences is a detail-oriented professional responsible for the strategic planning, organization, and execution of immersive brand experiences within General Motors. This role focuses on procuring and onboarding new creative agencies, conducting competitive analysis of automotive experiences, managing communications, overseeing budget planning, and executing on-site events. The senior manager will work closely with various internal stakeholders and external creative partners to ensure alignment with GM's brand objectives and community engagement initiatives. Key Responsibilities Agency Procurement & Onboarding: Lead efforts in identifying, evaluating, and onboarding creative agencies that align with GM's brand vision, ensuring all partnerships are strategically beneficial and effectively managed. Competitive Analysis: Conduct thorough competitive analyses of other automotive...

Position Overview The Principal Enterprise Architect is the technical liaison between development and the various Medical Informatics departments. Principal Enterprise Architects must have expert level knowledge in all areas of medical informatics; enterprise IT infrastructure design and deployment, medical imaging industry in general and clinical environment workflow. In addition to technical expertise, HCUS relies on the Principal Enterprise Architect to deliver industry leading customer satisfaction, requiring excellent communication and verbal skills within project teams and externally with customers. The Principal Enterprise Architect must be adept to working in highly dynamic multi-vendor environment and stay up to date on healthcare and general IT trends, best practices, regulations, and a wide range of hardware and software products. This position requires interaction with development, marketing, sales, technical support, field service, the end user, outside...

Job Summary The Senior Manager of Global Quality Management (GQM) supports the execution of clinical quality activities to ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and internal standards across global clinical trials. This role provides hands-on quality oversight, supports audit and inspection readiness, and collaborates with internal teams and external partners to maintain high-quality standards throughout the clinical development lifecycle. Key Responsibilities Clinical Study Support Serve as a GCP quality resource to clinical teams during study planning, conduct, and close-out. Support the review of study documents (e.g., protocols, monitoring plans, vendor agreements) for quality and compliance. Assist in identifying and resolving quality issues, protocol deviations, and potential noncompliance. Collaborate with Clinical Operations, Regulatory Affairs, and Medical Affairs to embed quality practices...