• Provides strategic statistical input to and oversees all statistical aspects of assigned programs; • Drives cross-functional collaboration and decision making for program(s); • Oversees the performance of Contract Research Organizations (CROs); • Develop and mentor other statisticians. • Ensures expert level contribution to strategy (design, analysis/synthesis, interpretation and reporting, health authority response, influence and implement publication strategy, quantitative decision making) for critical studies in a program. • Leads collaborations with clinical, regulatory and other strategic functions to drive quantitative decision making and enable successful impact on robust drug development plans. • Maintains indication specific standards with respect to key variables, variable definitions, statistical methods, data structures and presentation of results. • Provides oversight and guidance to staff members within 4DMT and in CROs in completing high quality study deliverables according to agreed timelines following quality standards.

• Primary preparation of statistical analysis plans and expert cardiac safety reports for clients with Clario consulting cardiologists • Provides scientific training to all staff and external consultants • Contribute to the development of a dedicated preclinical-early phase cardiac consulting service for external clients • Supports sponsor meetings (e.g. bid defense meetings, investigator meetings, kick off meetings, teleconferences) originated by project management or business development • Partner with the Sales team to provide sales support as needed • Participate in preparation of regulatory responses and submissions, interactions with health authorities as clinical pharmacology/pharmacometrics subject matter expert (SME) • Responsible for guiding model-based efficacious dose prediction for First-In-Human studies by interpreting and integrating in vitro and in vivo data from nonclinical studies for clients. • Representing Clario at scientific meetings, industry meetings, and webinars • Serve as an internal clinical pharmacology subject matter expert • Travel to client meetings or regulatory meetings may be required • Assist sales with client retention and the development of new clients. • Oversee other contract resources as assigned.

• This position focuses on disease states (e.g. prostate cancer, neuroendocrine tumors, & etc.) being treated by Novartis’ Radioligand Therapies. • The Regional Director of Medical Science Liaisons (RDM) is a field based, non-promotional medical and scientific leadership role. • Their key accountability is the development and execution of an impact-driven medical strategy for their assigned Field Team, aligned with the overarching Medical Strategy, with the goal of improving patient care. • The RDM provides strategic direction and leadership to their assigned Field Medical Team while functioning within the Novartis Code of Conduct, Ethics, Risk and Compliance policies and Working Practice documents. • The RDM drives execution of the medical strategies by setting the direction and providing clear communication of objectives and expectations to Medical Science Liaisons (MSLs) direct reports and strategic guidance regarding key accounts. • They are also accountable for performance of the MSLs within their team, optimal resource management, and the cultivation and recruitment of high performing talent through ongoing coaching and development. • The RDM is responsible for establishing a high performing team culture aligned to Novartis values and behaviors. • The RDM drives cross-functional collaboration through participation in forums to share best practices and build innovation. • They lead cross-functional collaboration with senior internal stakeholders to improve or implement novel approaches to partnerships with external customers (Medical Experts, HCPs, Accounts, etc.) to drive medical and/or clinical goals. • The RDM may serve as a peer leader driving internal initiatives and process improvements for the field teams. • They ensure field training and readiness, scientific expertise, understanding and adoption of technology, and compliant business practices of their respective field teams.

Role Description Otsuka is seeking a Director, Global Clinical Development (GCD) based Remotely or in our Princeton, NJ or Rockville, MD offices, who will be responsible for the design and oversight of clinical research programs and protocols for OPDC products under good clinical practices (GCP). The incumbent will be responsible for the evaluation and clinical development of Rheumatology, Immunology and Specialty Medicine products at different stages of development for a global health-care market. The specific duties assigned to the Associate Director/Director/Senior Director, Global Clinical Development include the following: - Consults with patients or their representatives, clinical, regulatory and scientific leaders and thoughtfully applies their recommendations toward optimizing trial objectives, designs and protocols. - Develops focused expertise to serve as an internal medical/scientific consultant to health economic, medical affairs, marketing, regulatory, statistical and other research project team members, and to external regulatory agencies. - Authors program strategies (i.e., GDCP) and oversees trials essential for determining the clinical safety, efficacy, medical usefulness and value of drug or medical device product candidates. - Interprets and communicates results of Phase I-IV investigations in preparation for a new drug. - Acts as the signatory on NDA submissions and clinical study and safety documents. - Involved in product life cycle management from the earliest stages of development, constantly seeking innovations to add value strategically. - Provides strategic oversight in our vendor and CRO relationships, and provides clinical input into their governance committees. - Will help lead and support regulatory filing activities and documents, providing strategic direction and editing to provide concise, clear and convincing argumentation in all such written and verbal communications. Qualifications - A clinician (M.D., or D.O.) preferably with a rheumatology, nephrology or immunology background, including prior management experience (direct or indirect). Supplementary degrees (e.g., Ph.D., M.P.H., M.B.A.) are a plus. - 3-6 years of experience in the pharmaceutical industry or in academic translational clinical research. - A thorough knowledge of clinical medicine and science management, including defining critical objectives clearly and maintaining focus toward achieving business outcomes on time, on budget and with superior quality. - An ability to communicate effectively in meetings and via written and oral presentations, including facility with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook). - Demonstrated experience leading, managing and motivating team members (e.g., internal staff and external investigators or consultants). - An advanced understanding of drug development principles and clinical trial implementation, management and reporting. - Flexibility in working across different therapeutic areas and experience in different stages of clinical development. - Working knowledge of associated disciplines, including biostatistics, clinical pharmacology, formulation science, data management, and medical writing. - Complete understanding of the global regulatory requirements. - Working knowledge of the principles of health value creation, including financial assessment (e.g., net present value), project planning and budgeting, market research and commercialization strategies. - Dedication to assigned, developed projects and project goals. - Willingness to travel 30% of time, over weekends and ability to travel internationally. Requirements - Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. - Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business. - Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders. - Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. - Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals. - Empowered Development - Play an active role in professional development as a business imperative. Benefits - Comprehensive medical, dental, vision, prescription drug coverage. - Company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance. - Tuition reimbursement and student loan assistance. - A generous 401(k) match. - Flexible time off, paid holidays, and paid leave programs. - Other company provided benefits.