Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to trials at all stages—from early development through approval—with embedded experience in oncology and rare disease. With over 2000 dedicated professionals and 35 offices worldwide, we stand ready to help accelerate life-changing treatments anywhere around the globe.

Provides overall leadership and direction of the Safety department across Precision for Medicine Clinical Solutions.  Directly, and through reporting managers, ensures timely, compliant, and accurate safety reporting in accordance with applicable regulatory requirements, Good Clinical Practice (GCP), and standard operating procedures (SOP). The role requires both a "hands on" approach and a strategic mind-set.

Essential functions of the job include but are not limited to:

• Provides people leadership and manages the day-to-day operations of the Safety department, e.g., setting direction, preparing and delivering annual performance reviews, coaching and mentoring
• Oversees the provision of safety services for clients in compliance with federal regulations, ICH guidelines, Good Clinical Practices, company Standard Operating Procedures (SOP) and client contractual arrangements.
• Leads the multidisciplinary team completing the configuration, validation, and implementation process and the ongoing management of the related vendors and consultants for the Argus database
• Works in a cross-functional manner to develop solutions in support of issue escalation
• Provides leadership and oversight of safety case processing, preparation of project-related documents, safety tools, and safety information or reports for clients and regulatory agencies
• Works with client and internal project teams to identify and address project safety needs from project start‑up through completion
• Works closely with executive management on resourcing for current and future projects
• Contributes to the development of internal processes including SOPs, Guidelines, and Work Instruction Documents
• Provides consultation to clients or potential clients on safety requirements, including methods of safety data collection, processing, surveillance, and reporting for clinical studies and post-marketing projects
• Prepares for and participates in client meetings and bid defense meetings
• Identifies and supports opportunities for the expansion of safety services
• Provides oversight for safety analyses
• Follows applicable regulations, including FDA, ICH, and Precision For Medicine Clinical Policies and Procedures
• Other duties as assigned

Qualifications:

Minimum Required:

• BA/BS in the biological sciences or related disciplines in the natural science/healthcare field, nursing degree, or equivalent combination of education and experience.

Other Required:

• Minimum of 15 years of experience in safety in the CRO or pharmaceutical industry; minimum of 10 years in managerial role in drug safety
• Solid knowledge of FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global safety regulations.
• Experience with the ARGUS safety database
• Demonstrated effective people leader
• Ability to effectively adapt to a variety of situations
• Strong influencing skills
• Excellent communication skills, both written and oral
• Works effectively as a team member and promotes collaboration
• Demonstrates ownership, initiative, and accountability
• Approximately 10% travel 

Competencies:

• Experience managing direct reports
• Demonstrated people leadership abilities to lead a department of professionals
• Strong analytical and problem-solving skills
• Highly organized with excellent presentation, oral, and written communication skills
• Strong interpersonal skills, and a proven ability to foster a culture of mutual respect and collaboration
• Proven ability to effectively influence others, negotiate, and manage conflict
• Ability to manage tight timelines, prioritizing workload and maintaining high quality standards.
• Continuous improvement mindset including the ability to make proactive assessments on how to make processes more efficient and people more effective
• Demonstrates a high degree of professionalism, as evidenced by ability to deliver on commitments, an understanding of the service culture, and positive interactions with customers and teammates, including good interpersonal skills in the areas of diplomacy and negotiation

Ability to assess and quantify risks to the company, both internal and external