Full-Time 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 report
• Provide 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 organizations
• Oversee 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 outcome
• Approve final investigator site selection for clinical trials
• Coordinate all relevant Clinical Operations activities/documents related to regulatory and ethics submissions
• Manage the implementation of the Clinical Operations by providing direction and oversight to the Clinical Research Managers and Medical Manager/Advisor in the region
• Develop and manages the Clinical Affairs budget within stated financial goals
• Approve CRO and other vendors as appropriate
• Participate in the preparation of periodic regulatory agency reports
• Direct line management and mentorship to clinical research personnel
• Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team
• Collaborate with key functional areas to meet corporate goals and objectives
• Work with other Clinical Operations staff globally to ensure consistent application of performance expectations, compensation decisions, and succession planning
• Responsible for making Clinical Operations resource allocation projections and decisions based on program prioritization
• May manage all aspects of an assigned clinical program or program(s) globally, as appropriate
• Participate in due diligence activities as required

EDUCATIONAL PREREQUISITES AND SKILL REQUIREMENTS:

• Requires 10+ years of clinical research experience managing clinical projects and preferably multinational projects
• Advanced degree (MD, PhD, PharmD) required
• Proven ability to lead and grow diverse teams globally
• Experience in interventional oncology, radiopharmaceuticals and interventional radiology strongly preferred
• Excellent interpersonal and communication skills with experience of complex scientific and clinical data evaluation and presentation
• Experience in Medical Device and/or Biopharmaceutical clinical trials
• Experience in Medical Device and/or Radiopharmaceuticals required
• 3-5 years of monitoring experience desirable; CCRA preferred
• Demonstrated experience in core and technical aspects of clinical trial conduct, which may include Site, CRO, Pharma, Biotech, and/or IRB related experience
• Thorough knowledge of GCP, ICH guidelines, ISO and regulatory requirements for clinical development
• Excellent project management skills, including risk assessment and contingency planning
• Excellent communication, management, and organizational skills, along with problem solving, conflict resolution, leadership and team building skills
• Excellent IT office software skills
• Data management experience
• Experience in budget development and management
• Prior experience with trials spanning all phases of development and implementation
• Experience in FDA approval pathways and ability to interact with FDA and other regulatory bodies

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