Senior Manager Clinical

Work Flexibility: 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.
• 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.

What will you do:

• 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.

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.
• 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.
• 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.
• Experience with recruiting, people development.
• Influence across the organization.
• Ability to understand scientific and health concepts.
• 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