"Alerted.org

We seek an experienced professional to lead our Safety and Regulatory Analytics initiatives. This role is responsible for transforming data into actionable insights that will drive business decisions, enhance patient outcomes and optimize product development. The role will serve as a key partner to drive data-driven operation and decisions with the clinical development stakeholders.

General Description:

We seek an experienced professional to lead our Safety and Regulatory Analytics initiatives. This role is responsible for transforming data into actionable insights that will drive business decisions, enhance patient outcomes and optimize product development. The role will serve as a key partner to drive data-driven operation and decisions with the clinical development stakeholders.

Essential Functions of the Job:

Data Analytics & Interpretation:

+ Set the analytics strategy and roadmap with business stakeholders across portfolio

+ Align cross-functional analytical insight strategy and roadmap and ensure consistent insight delivery

+ Provide senior leadership with forward-looking analyses, predictive models, and risk assessments to inform governance and prioritization

+ Deliver development of safety signal detection, integrated safety review, risk evaluation and safety operation using clinical trial, real-world and post-marketing surveillance data.

+ Partner with regulatory affairs teams to establish and monitor competitive landscapes, approval trends, KPIs, monitor submission cycle times, response quality, and agency feedback trends, driving efficiencies and compliance

+ Utilize advanced analytics, machine learning, and artificial intelligence techniques to identify trends, patterns, and opportunities within complex datasets, directly applying these capabilities to address business challenges.

+ Ensure the accuracy, integrity, and security of data to meet compliance standards and regulatory requirements.

Stakeholder Engagement:

+ Translate business and cross-functional questions into well-structure analyses with actionable recommendations

+ Understand business and organization in-depth, familiar with business process, strong business acumen

+ Act as a key point of contact and partner to product managers and business functions to define KPIs, OKRs, metrics as pertained to pharmacovigilant and regulatory affairs, develop and implement role-based dashboards or analytical tools to track business operations, performance and suggest data-driven next best actions.

Innovation and Continuous Improvement:

+ Stay abreast of industry trends, emerging technologies, and best practices in data analytics and insights to drive innovation within the organization.

+ Hands-on experience in implementation and operationalizing AI/ML solutions in business context, technically proficient in various algorithms and models

+ Identify and improve processes continuously, explore the opportunities of doing things differently and smartly

Team Management:

+ Manage a team of data scientists and data analysts or managers or senior members of the team, developing talent, and fostering a culture of continuous improvement

+ Foster a culture of curiosity, accountability and continuous improvement

+ Promote data-driven decision-making at the study and program level through hands-on support and stakeholder engagement.

Education/Experience Requirements:

+ Bachelor’s degree in Data Science, Computer Science, Life Sciences, or related field and 8+ years’ experience in data analytics, insights, or related fields required

+ Master’s degree in Data Science, Computer Science, Life Sciences, or related field and 6+ years’ experience in in data analytics, insights, or related fields

+ PhD in Data Science, Computer Science, Life Sciences, or related field and 4+ years’ experience in in data analytics, insights, or related fields

+ Proven track record of managing large-scale data projects and leading high-performing teams

+ Familiar with clinical systems, e.g., EDC, CTMS, IRT, Argus and other systems

+ Hands-on experience with AI/ML frameworks and libraries to develop algorithms in business context. Familiarity with Agentic AI is a plus

+ Excellent communication and presentation skills, with the ability to convey complex data insights to non-technical stakeholders

+ Strong interpersonal skills and the ability to lead cross-functional teams and influence at all levels of the organization

+ Strong capability of prioritizing and handling multitasks, executing quickly

+ Be able to work under pressure

+ Strong proficiency in data analysis tools and programming languages

+ Exceptional analytical, problem-solving, and critical-thinking skills

+ Self-motivator, hands-on, disciplined and proactive person with great team-work spirit and strong accountability

Supervisory Responsibilities:

+ 4+ years in a management role overseeing analytical insights

Computer Skills:

+ Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).

**Travel:** Minimum

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.