Senior Manager Clinical

Hybrid Who we want: A Leader to develop clinical center of excellence, develop organizational strategies, processes, goals, and metrics to drive measurable improvement in clinical processes.

Responsibilities

• Oversee consistency in clinical processes.
• Drive new approaches to improve the development, review, and oversight of clinical projects.
• Collaborates with internal and external stakeholders to direct and contribute initiatives within the organization.
• Someone who provides global and/or regional leadership to execute large scale and/or complex clinical programs for assigned therapeutic area.
• Oversee the planning, design, and execution of pre-clinical (if applicable), clinical studies ensuring they are conducted in accordance with applicable regulations and standards.
• Lead the development of clinical study protocols, ensuring they are scientifically rigorous and ethically sound.
• Manage day-to-day clinical processes to ensure issues are appropriately evaluated Manage and mentor a team of clinical professionals.
• Establish annual budgets and quarterly forecasts.
• Make necessary changes with appropriate management involvement.
• Communicate and collaborate with regulatory, quality, R&D, Global Supply, Finance, Sales, and Marketing departments to ensure corporate goals and strategies are met Serve as Subject Matter Expert for clinical processes.
• Provide guidance, recommendations, and implementation plans for adherence to new clinical requirements or expectations.
• Establish standard process to ensure appropriate resolution and management of the responsible task owner.
• Chair meetings required to drive closure of clinical issues.
• Manage and provide updates for clinical metrics.
• Implement appropriate enhancements.
• Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targets.
• Recruit, select, and on-board top talent.
• Develop talent within team to increase performance.
• Actively address performance issues on team.
• Maintain a high level of team engagement.
• Experience with recruiting, people development.
• Lead, Develop, Solution, Functional Representative Lead cross functional projects and departmental initiatives.
• Support larger scale cross functional or intra-divisional initiatives Consistently demonstrating influencing skills impacting cross functional project and /or departmental results Travel Percentage: None

Requirements

• What you need Minimum of 15 years of experience; minimum 8 years of management experience required and / or experience in leading critical projects for the business.
• A bachelor's degree in a relevant field such as life sciences, biology, biomedical engineering, nursing, or a related discipline.
• Demonstrated knowledge and application of clinical requirements, including ISO, FDA, and International requirements.
• Demonstrated ability to expand application of clinical and regulatory knowledge to interdivisional projects as needed.
• Demonstrated written, verbal, listening, communication, and team-building skills.
• Demonstrated ability to collaborate effectively with and lead cross-functional teams.
• Demonstrated ability to effectively prioritize and manage multiple project workloads.
• Demonstrated experience with trending and analysis reporting.
• Demonstrated leadership skills.
• Demonstrated process improvement and management skills.
• Influence across the organization.
• Ability to understand scientific and health concepts.

Preferred

• An advanced or master’s degree, or certifications in clinical research and project management preferred.
• Knowledge Competencies Strong experience in the medical device field required, experience in the pharmaceutical industry considered.
• Previous experience with regulated global trials highly preferred.