Job Description:

Acts as the scientific lead for clinical program development activities within a product group or within a portfolio. Determines product and portfolio level standards for clinical development planning, scientific document content, data analysis and reporting,and reporting to senior management, OPCJ and affiliates. Ensures that scientific content of development plans and protocols meets requirements for simultaneous regulatory submission and optimal market access. Supports Medical Affairs and other functional areas in reporting program activities and results. Serves as a "resident expert" within OPDC for issues related to clinical development planning, program management, and internal reporting. May directly supervise clinical management personnel. Serves as a member of the Clinical Management Leadership Team. Provides scientific clinical research and operational expertise in the development of overall strategy and objectives of the GCDP, including performing/overseeing and providing background research (literature, SBA, competitive intelligence, regulatory guidance etc)

Responsibilities:

·        Directs development of current program level training materials, program slide updates for management, and program level template. Provide/support program level presentations & training.

·        Ensures program specific standards (e.g., CRFs, outsourcing specifications, slides, training) are developed and applied across all trials to ensure consistency of clinical dossier.

·        In collaboration with the protocol team, leads the clinical trial data ongoing medical/scientific review focusing on data integrity, trending & consistency across the program. Contributes to final analysis and interpretation including the development of clinical trial reports, publications and internal/external presentations.

·        Serves as support for global affiliates in relation to regulatory filings, trial implementation, training etc.

·        Develops and presents long-term program level financial estimates (MLTE) as part of overall program strategy. Provides advice to senior management for budget adjustments across programs, portfolio, or OPDC, as requested.

·        Leads program level teams as Co-Chair and/orserves as lead clinical management representative for CRT/GBT/PDC/JDC/Alliance teams.

·        Contributes to the preparation and defense of clinical program documents (investigator brochure/IMPD, IND/CTA annual reports, Health Authority briefing books and submissions (NDA, MA, NDS etc.), including ongoing maintenance of filings and support of labeling teams. Leads development of clinical sections of regulatory documents (i.e. Investigators' Brochures, briefing books, submission dossier, and responses to Health Authorities questions) and inspection readiness programs, where appropriate.

·        Develops strong scientific partnership with key advisors in assigned therapy area to optimize scientific quality/innovation of clinical study design, execution, reporting and publication. Leads program-related advisory boards/committees and meetings.

·        Supports the design & implementation of a program level HEOR strategy, including endpoint development where necessary.

·        Coordinates and/or supports program level inspection readiness strategies in preparation for and defense of global regulatory filings and ongoing marketed products.

·        Serves as contact for Medical Affairs/PBS related to medical information requests, public disclosure of information (e.g., clinicaltrials.gov) and publications strategies. Provides program training and interactions with MSLs, as appropriate.

·        Represents assigned programs to senior management and OPCJ, and disseminate information and tasks to team members.

·        Assists Senior Director with departmental resourcing activities.

·        Gives direction, training, and support to Clinical Management personnel within portfolio/compound team. Assists supervisors in skill set development activities.

·        Leads assigned departmental, External Service Provider partnership, and corporate standardization and continuous improvement efforts for issues relating to program design and execution.

·        Analyzes best scientific conduct and planning practices across products and portfolios. Designs and implements plans to incorporate practices• Researches and investigates industry best practices in the areas of clinical development planning, and endpoint design/validation/reporting. Shares OPDC best practices in industry-wide forums.

·        Serves as a PORT reviewer for protocols within and across portfolios.

·        Sets performance expectations for each direct report. Establishes a feedback loop among employee's peers (on departmental and project teams). Provides specific and frequent feedback to the employee on his/her performance. Creates individual development plans.

·        If supervising employees, responsible for training and orienting new employee on corporate culture, corporate expectations and departmental/organizational policies and procedures. Works with various groups to devise training program(s) for the employee and makes arrangements for such sessions to be conducted.

·        Ensures the employee has access to all required material, systems to satisfy their individual job responsibilities.

·        Communicates corporate decisions in a timely and effective manner through various venues to ensure staff are aware of updates to corporate culture, vision and management.

Knowledge:

·        Advanced knowledge of clinical trial design, the drug development process, and the clinical concepts involved  in assigned projects.

·        Must be a credible and knowledgeable representative of project to KOLs and Investigators.

·        Advanced understanding of drug development principles and clinical trial implementation and management. Strong

·         knowledge of global regulatory requirements and compliance, biostatistics, data management, and medical writing.

·        Understanding of overall corporate goals with a fundamental grasp of basic principles to work in a business setting.

Skills:

·         Excellent skills in designing and managing global clinical trials and the ability to contribute strategically to development of clinical development programs from first-in -man through life-cycle management.

·         Must be able to form and articulate a clear vision to successfully guide all clinical team members (e.g., internal staff and external investigators/consultants).

·         Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).

Required:

·         Bachelor's degree with a minimum of 12 years of applicable pharmaceutical industry experience. Previous

·         Supervisory experience.

Preferred: Advanced degree

Apply Online at:

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Company Description:

Otsuka Pharmaceutical Development and Commercialization, Inc. (OPDC) is involved in conducting all phases of clinical research and development of innovative healthcare products to address unmet medical needs. OPDC is well established in the scientific community as a globally focused organization that plays a leadership role in the research and development of Otsuka's ethical healthcare products. The Company is dedicated to the improvement of the quality of human life and health of its patients around the world with a strong commitment to research and development in the areas of cardiovascular, respiratory, renal and neuroscience systems, and to treat cancer and ophthalmic disorders.