Director, Pharmacoepidemiology

This is a fully remote position, open to applicants in United States.

📋 Description

• Establish effective external partnerships across key sectors.

• Assist in identifying, executing, and managing strategic relationships with organizations and institutions.

• Collaborate across matrixed teams to pinpoint opportunities and enhance the initiation and maintenance of external partnerships.

• Develop an internal capability for external partnerships that is highly regarded by both partners and leadership.

• Collaborate with internal leaders engaged with external partners to ensure effective cooperation, continuity, and alignment.

• Formulate and execute a pharmacoepidemiology strategy within a specified therapeutic area.

• Lead cross-functional project teams and epidemiology initiatives, including studies mandated by regulatory agencies.

• Generate epidemiology data that supports clinical development, regulatory submissions, and approvals.

• Act as an in-house expert in epidemiology.

• Produce real-world evidence and conduct post-marketing epidemiological studies, including PASS, PAES, PMR, DUS, and the effectiveness of REMS and RMMs.

• Contribute to Risk Management Plans, benefit-risk assessments, signal management, responses to regulatory agencies, and regulatory submissions.

• Offer epidemiological and risk-management strategies and support to project and product teams.

• Design, implement, and analyze epidemiological studies.

• Review study proposals from both internal and external sources.

• Investigate external electronic patient-level databases, including claims, EMR, surveys, and registries.

• Represent Pharmacoepidemiology on safety monitoring teams, clinical study teams, safety oversight committees, and independent data monitoring committees.

• Oversee non-compound-specific activities such as literature reviews and database inquiries.

• Create and maintain relevant Standard Operating Procedures (SOPs) and Working Instructions.

• Propel process improvement initiatives and strategic projects.

• Manage contractors and external vendors.

• Foster and sustain professional relationships with external experts and opinion leaders.

⛳️ Requirements

• A minimum of a Bachelor’s degree.

• Over 8 years of relevant experience in the Biotech/Pharma industry.

• Qualifications that are in line with the Director level.

• Proficiency in the latest epidemiologic methods and resources.

• Prior experience and a thorough understanding of the drug development process.

• Ability to manage and prioritize numerous tasks and projects with urgency in a matrix environment.

• Experience in planning and execution, demonstrating strategic thinking and tactical implementation.

• Strong business and financial management skills.

• Proven capability to build consensus among leaders and colleagues.

• A successful history of developing and maintaining partnerships at all organizational levels.

• Results-driven and collaborative approach.

• Demonstrated resilience, initiative, and sound judgment.

• Exceptional verbal and written communication and presentation abilities.

• Capacity to communicate clearly and concisely.

🏝️ Benefits

• Annual bonuses or incentive plans.

• Equity awards.

• Pension or retirement benefits.

• 401(k) company match.

• Health and wellness programs.

• Access to fitness centers.

• Comprehensive medical, dental, vision, life, and disability insurance benefits.

• Paid time off.

• Family support benefits.

• Reasonable accommodation for applicants with known disabilities or chronic illnesses during the recruitment process, as necessary.