Vice President, Safety

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 mentoringOversees 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 databaseWorks in a cross-functional manner to develop solutions in support of issue escalationProvides leadership and oversight of safety case processing, preparation of project-related documents, safety tools, and safety information or reports for clients and regulatory agenciesWorks with client and internal project teams to identify and address project safety needs from project start‑up through completionWorks closely with executive management on resourcing for current and future projectsContributes to the development of internal processes including SOPs, Guidelines, and Work Instruction DocumentsProvides 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 projectsPrepares for and participates in client meetings and bid defense meetingsIdentifies and supports opportunities for the expansion of safety servicesProvides oversight for safety analysesFollows applicable regulations, including FDA, ICH, and Precision For Medicine Clinical Policies and ProceduresOther 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 safetySolid knowledge of FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global safety regulations.Experience with the ARGUS safety databaseDemonstrated effective people leaderAbility to effectively adapt to a variety of situationsStrong influencing skillsExcellent communication skills, both written and oralWorks effectively as a team member and promotes collaborationDemonstrates ownership, initiative, and accountabilityApproximately 10% travel

Competencies

Experience managing direct reportsDemonstrated people leadership abilities to lead a department of professionalsStrong analytical and problem-solving skillsHighly organized with excellent presentation, oral, and written communication skillsStrong interpersonal skills, and a proven ability to foster a culture of mutual respect and collaborationProven ability to effectively influence others, negotiate, and manage conflictAbility 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 effectiveDemonstrates 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

Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.

Reasonable estimate of the current range

$240,000 — $325,000 USD

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