Director Pharmacoepidemiology

Proclinical; Lavamünd; Presencial; CHF 141 000 - 208 000; Tempo integral

Resumo da oferta

Proclinical is seeking a Director of Pharmacoepidemiology to join our team remotely within the US. You will lead the development and implementation of strategic pharmacoepidemiology programs across therapeutic areas and collaborate with cross-functional partners to support regulatory filings and post-marketing commitments.

The role requires strong epidemiologic methods expertise, leadership, and a track record of working in biotech or pharma environments, with the ability to influence

Qualificações

• Bachelor's degree or higher with relevant industry experience in biotech or pharma.
• Strong epidemiologic methods and study design experience.
• Proven ability to influence regulatory strategies and decisions.
• Excellent presentation and writing skills; adept at cross-functional collaboration.

Responsabilidades

• Develop and implement pharmacoepidemiology strategies, including real-world evidence generation and regulatory studies.
• Lead post-marketing commitments (e.g., PASS, PMR) and assess REMS/RMM effectiveness.
• Contribute to risk management plans, benefit-risk analyses, and regulatory responses.
• Collaborate with Safety, Clinical, Regulatory, and other teams to design and analyze epidemiological studies.
• Explore external databases (claims, EMR, registries) to answer safety-benefit questions.
• Represent Pharmacoepidemiology on cross-functional teams and study integration.
• Support SOPs, work instructions, and process improvements; manage contractors.

Conhecimentos

Leadership

Cross-functional collaboration

Epidemiology expertise

Regulatory strategy

Communication skills

Project management

Business acumen

Formação académica

Bachelor's degree in biotech/pharma

Ferramentas

SAS

R

Real-world data sources

Descrição da oferta de emprego

Director, Pharmacoepidemiology- Contract - Remote, US

Are you a pharmacoepidemiology leader looking to shape evidence-generation strategies that influence drug development, regulatory decisions, and patient safety on a global scale?

Proclinical is seeking a Director of Pharmacoepidemiology to join a dynamic team remotely within the US.

Primary Responsibilities:

The successful candidate will lead the development and implementation of pharmacoepidemiology strategies within the designated therapeutic area. You will collaborate with cross-functional teams to support regulatory filings, clinical development, and post-marketing commitments. This position requires expertise in epidemiologic methods and the ability to provide strategic insights to influence decision-making processes.

Skills & Requirements:

• Strong collaboration and results-oriented mindset with the ability to build consensus across teams.
• Proven experience in the drug development process and navigating matrix organizations.
• Ability to manage multiple tasks and projects with urgency and strategic focus.
• Excellent verbal and written communication skills, including presentation abilities.
• Demonstrated business and financial acumen with a track record of process improvement.
• Resilient and innovative, with the ability to explore alternative solutions to achieve outcomes.
• Minimum of a Bachelor's degree with relevant industry experience in biotech or pharma.

The Director's responsibilities will be:

• Develop and implement pharmacoepidemiology strategies, including real-world evidence generation and regulatory agency-required studies.
• Lead activities such as post-marketing commitments (e.g., PASS, PAES, PMR, DUS) and evaluate the effectiveness of REMS and RMMs.
• Contribute to risk management plans, benefit-risk analyses, signal management, and responses to regulatory queries.
• Collaborate with Global Patient Safety, Clinical Scientists, Regulatory Affairs, and other functions to design, implement, and analyze epidemiological studies.
• Explore external databases (e.g., claims, EMR, surveys, registries) to address safety-benefit questions and support clinical development.
• Represent Pharmacoepidemiology on cross-functional teams, including Safety Monitoring Teams and Clinical Study Teams.
• Drive non-compound-specific activities such as literature reviews and database queries for regulatory filings.
• Participate in the development and maintenance of SOPs, working instructions, and process improvement initiatives.
• Manage contractors and external vendors as needed.
• Build and maintain professional relationships with external experts to ensure high-quality evidence generation.