Executive Director (DG)
Job Location: New York
Date Posted: 2020-03-31
Executive Director, Late Clinical Development Biostatistics
Directs statistical support and provide statistical leadership for all areas of late-phase clinical development and has responsibility for strategic and operational activities. Promote development of key staff responsible for individual projects or areas. Implement and maintain policy for recruitment of high potential staff. Assisting VP, BDM, in the development and implementation of departmental scientific policies, operational guidelines, and administrative structure. Responsible for project staffing and for appropriate resource allocation consistent with corporate priorities. Incumbent could serve as senior research expert, with demonstrated ability to be a leader within Global Clinical Operations (GCO) and within field for specific statistical methodology or application.
Determines in conjunction with department Vice President, department goals, and resource allocation. Ensure project teams have high quality statistical support for creation of clinical development plans (CDP), study design, and operational aspects. Oversee process for statistical reporting. Review critical documents, such as SAP, Key Results, CSR, and integrated summaries. Ensure compliance with data submission guidelines. Ensure appropriate statistical designs, data collection and analysis methodologies and processes to clearly and robustly address the objectives of clinical studies and programs. Lead development and optimization of statistical processes with specific focus on efficiency and quality, while maintaining or exceeding industry best practices. Work with senior management to ensure statistical representation in key project decisions and regulatory meetings. Serve as departmental representative on corporate-wide teams. Plan and track project activities, timelines, and resource use. Provide justification for planned resource needs. Seek to optimize resource utilization across projects or areas. Effect long-range planning. Sets strategy for how department will improve technical expertise and ensure technical direction and mentoring of staff. Develops staff on technical and personal development. Establishes a healthy culture in the department, including collaboration, quality mindset and motivation. Oversees late stage clinical development. Manages other senior managers and is accountable for all statistical aspects of clinical studies and submissions, including quality, relevance to regulatory perspective, and scientific validity. Identify business problems and establishes functional strategy, in collaboration with Head of BDM, and provides direction for team to craft solutions. Thorough working knowledge of regulatory guidelines. Understanding of the drug discovery and development process, regionally and globally. Alert staff to new or changing standards. Within area of control, harmonize policies with departmental guidelines / SOPs and with industry standards. Develop polices promoting application of corporate values in work practices. Liaise with other company function leaders to influence, shape, and drive unified strategies related to integrated development programs and regulatory submissions. Active research interest in area related to clinical trial. Advises all relevant employees about the procedures surrounding retention of data, records, and information for employees in their group. Participates in task forces and cross-functional operational excellence initiatives. Actively participates in statistical conferences and proactively seeks ways to represent company externally and to sponsor internal staff to be active at external professional meetings. Able to influence regulatory agencies, in both product-related forums and more generally in the industry and works with company to develop a regulatory strategy. Sponsor/leader of cross-functional process initiatives. Monitors performance of direct reports and proactively identifies and addresses gaps/issues to ensure performance goals/expectations are met. Will have own individual objectives of a strategic nature at department and company levels. Decisions will result in the long-term success of the function and will strongly influence the long-term success of the company. Works closely with senior management. Establishes department in a leadership role in drug development and drives how the company approaches product development. Extended member of DPR, PRC. Conducts all pre-PRC and pre-DPR reviews for BDM, within their area of responsibility. Ensures teams have appropriate plans, and reviews program and study strategy with teams, and mentors teams to improve their effectiveness in committee and senior management meetings.
Ph.D. in Statistics or related discipline with 13+ years of experience in the biotechnology, pharmaceutical or health related industry, including significant interaction with both FDA and EMEA, history of successful project and people management (6+ years), and expertise in multiple therapeutic areas.
Works in a changing and busy environment. Exercises judgment in interpreting, modifying, and adapting procedures, practices, methods, etc. in accordance with existing policies and standards for application to specific problems or tasks. Works independently - self-directed, high energy and strong work ethic. High degree of creativity, latitude and attention to detail required. Demonstrated strong leadership, project management, teamwork, and interpersonal skills. Excellent presentation skills. Responds well to questions, speaks clearly and persuasively in positive and negative situations. Demonstrated written and oral communication skills. Listens and gets clarification. Adaptability- Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Strives to continuously build knowledge and skills; Shares expertise with others. Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance. Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully. Responds to management; takes responsibility for own actions; keeps commitments; completes tasks on time or notifies appropriate person with an alternate plan. Experience and proven ability leading and managing major process and technology initiatives with utilization and impact across multiple functional groups. Broad knowledge and superior understanding of advanced statistical concepts and techniques. Outstanding ability and skills to effectively represent Biostatistics and Data Management in interaction with senior management or cross-functional committees. Thorough knowledge of pharmaceutical clinical development and life cycle management; ability to innovatively apply technical principles, theories and concepts to clinical drug development leading to regulatory approvals. Thorough working knowledge of regulatory guidelines on drug development, regulatory submissions, and statistical practice. Understanding of the drug development process, regionally and globally. Strong administrative skills. SAS, S-Plus/R, Sample size calculation software (e.g., EaSt and Nquery).
Please contact Darren Gutowski at email@example.com
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