Associate Director, Global Clinical Safety - Medical Devices (on-site)

The Opportunity

Our location in Santa Clara, CA or Maple Grove, MN currently has an on-site opportunity for an Associate Director, Clinical Safety professional.

Reporting to the Global Safety Director, this position will provide leadership, management, and direction for Clinical Safety for Abbott’s clinical trials.

This new team member is responsible for oversight of medical device safety performance, oversight in the development and maintenance of project-specific Safety Plans, Abbott Standard Operating Procedures (SOPs) and Work Instructions related to safety, and ensuring required regulatory reporting requirements are met.

What You’ll Work On

• Directs all activities related to safety components of Abbott’s clinical trials.
• Accountable for Safety support of up to 3 business units and their associated product portfolios.
• Provide strategic leadership and subject matter expertise for safety of the medical devices used in the clinical studies.
• Work cross functionally to implement relevant guidelines into Abbott practices and procedures.
• Oversight of the staff that perform the day-to-day clinical trial adverse event processing function and serious adverse events reporting to regulatory agencies following the company policies and applicable US and international regulations.
• Support projects or other initiatives from cross-functional groups and departments (i.e., Project Management teams, Scientific group, Quality / Compliance, Data Management, Biostatistics and Regulatory Affairs), and ensure adequate safety support and timely update of safety information to internal and external stakeholders.
• In collaboration with Clinical Science and Project Management, contribute to or review regulatory and clinical documents including Clinical Reports, Informed Consent Forms, pre-market submission documents, and responses to regulatory authority inquiries.
• Provide support and review study-specific documents for clinical trials including CIP, safety-related case report forms, and design of tables and listings for safety data from clinical studies to present to independent committees.
• Understand the legal and compliance environment and drive collaboration with the Clinical Quality & Compliance team.
• Undertake activities to maintain a state of inspection readiness and participate in audits, including being the representative and point of contact for inspections by regulatory authorities and internal audit requests / questions related to the safety data.
• Review and assist with responses to safety-related queries from Ethics Committees, if needed.
• Provide staff training and mentoring; monitor performance of direct reports and provide constructive feedback and coaching.
• Build effective safety teams, motivate, delegate, and drive timely / quality decision-making and operational performance.
• Manage and provide oversight of activities performed by the Safety Specialists and Safety Monitors, including but not limited to quality review and assessment of SAEs, SAE and Device Deficiency reporting, event trending, narrative writing, appropriateness of queries to clinical sites, and accuracy of MedDRA coding.
• Review and update proposals, budgets and contracts as required.
• Take a proactive, solutions-based approach, prioritize and manage multiple, varied tasks with enthusiasm and attention to detail.
• Thrive in a matrix environment and to value the importance of teamwork.
• Provide recommendations and input regarding safety activities, goals and objectives. Make judgments and decisions in a sound logical manner.
• Drive the spirit of "ONE Team" across all functions by supporting a team approach to focus on our patients and customers as our top priorities.
• Maintains knowledge and an in-depth understanding of current clinical regulations and common industry practices. Seeks continued education on disease state relevant to the study patient population, Abbott devices, and corresponding therapies.
• Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Maintains a safe and professional work environment.
• Responsible for improving operational efficiency and effectiveness within the functional area assigned. Directs auditing activities of the clinical files to assure complete documentation and compliance with the study protocol.

Creates and enforces departmental standards and procedures. Provides input and implements Safety management processes defined in the worldwide Standard Operating Procedures (SOPs).

Required Qualifications

• Bachelor’s degree in health sciences, biological sciences or related field OR an equivalent combination of education and experience
• Minimum of 10 years in clinical research for a medical device or pharmaceutical company
• Progressive leadership experience in functional area or related field.
• Solid knowledge of clinical biostatistics and applicable clinical trial regulations both US and OUS.
• Demonstrated leadership / management skills with respect to achievement of company goals and objectives.
• Must possess comprehensive written and verbal communication, interpersonal, presentation, analytical, project management skills and the ability to prioritize and handle a large volume of projects simultaneously and meet deadlines.
• Skillful in formulating strategies, tactics, and action plans to achieve results.
• Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
• Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail.

Preferred Qualifications

• Bachelor’s degree in medicine, pre-medicine, nursing, life science, bioengineering; Master’s degree
• Experience working in a broader enterprise / cross-division business unit model. Ability to work in a highly matrixed and geographically diverse business environment.
• Solid understanding and working knowledge of US and international medical devices regulatory requirements (e.g., US Code of Federal regulations;

European MDR; and ICH Guidelines). China and Japan safety reporting experience is a plus.

• Previous strong clinical experience in cardiology; vascular and neurology.
• An excellent understanding of all aspects of clinical research with previous experience within a clinical or corporate setting or relevant clinical experience in a clinical / hospital environment
• Previous experience in a hospital or clinic setting, within the cardiovascular or neurology specialties.
• Experienced in pre- and post-approval study activities, with the focus on safety reporting, safety data analysis, categorization, assessment.
• Problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency and the ability to successfully execute in an environment under time and resource pressures.
12 days ago