Senior Director, Global Clinical Development

The Senior Director of Clinical Affairs will provide leadership and broad scientific and medical input to activities that span across the scope of clinical development, including leading strategic planning and execution of clinical development plans, providing support of regulatory submissions, contributing to/leading the development and execution of the medical/clinical affairs plan. The candidate should be able to work in a cross functional manner to bring a broad range of input into partnerships with internal stakeholders but be able to work with key opinion leaders/PI's/and leading clinical sites for external input into the program's strategy. The individual in the role will also be responsible for establishing, implementing and maintaining departmental policies, procedures, and strategies to ensure that trials are performed in accordance with Good Clinical Practices (GCP) and ISO 14155.PRIMARY RESPONSIBILITIES:Collaborate with Medical Directors, MSLs, Research and Development (R&D) the Heads of Regional Sales and Marketing (S&M), Global Head of Marketing, Global Head of Quality and Regulatory and Health Economics to execute clinical programs. This position will report to the SVP of Medical & Clinical Affairs.Ensure appropriate scientific rigor in the design, conduct, validity and interpretation of clinical trial to support regulatory applications or business/marketing objectives.Identify significant issues that may impact overall project plans and initiate contingency plans as appropriate.Deliver clinical/scientific input during the development and execution of clinical trials including protocol development through the review and interpretation of trial results and finalization of the clinical study reportProvide medical expertise and support to externally facing groups/stakeholders, including the field medical team, medical information, the commercial organization, expert advisors and key opinion leaders, payers and commercial advisors, and professional organizationsOversee implementation of clinical trials globally by approving execution plans in agreement with the SVP of Medical & Clinical Affairs.Manage and maintains metrics across clinical trials (e.g. patient recruitment to study goals, expenditure and cash flow to budget, administrative compliance and safety reporting. Ensures that ongoing data review is performed for studies, as appropriate and that clinical trials will deliver the highest quality data to maximize likelihood of successful trial outcomeApprove final investigator site selection for clinical trialsCoordinate all relevant Clinical Operations activities/documents related to regulatory and ethics submissionsManage the implementation of the Clinical Operations by providing direction and oversight to the Clinical Research Managers and Medical Manager/Advisor in the regionDevelop and manages the Clinical Affairs budget within stated financial goalsApprove CRO and other vendors as appropriateParticipate in the preparation of periodic regulatory agency reportsDirect line management and mentorship to clinical research personnelUnderstand the legal and compliance environment and drive collaboration with the Legal and Compliance teamCollaborate with key functional areas to meet corporate goals and objectivesWork with other Clinical Operations staff globally to ensure consistent application of performance expectations, compensation decisions, and succession planningResponsible for making Clinical Operations resource allocation projections and decisions based on program prioritizationMay manage all aspects of an assigned clinical program or program(s) globally, as appropriateParticipate in due diligence activities as required