Director Real World Evidence

Job Title: Director of Real-World Evidence and Data Analytics

Overview:
Join our client, a pioneering biotechnology innovator, in their mission to cure rare childhood diseases through advanced gene therapies. This is an exciting opportunity to become a key part of a highly collaborative team, contributing to an entrepreneurial, scientifically driven organization. The role offers a competitive compensation package, including excellent health benefits.

Responsibilities:

• Develop and drive innovative evidence strategies in collaboration with cross-functional partners to support the value of our client's therapies.

• Identify the scientific questions that will lead to the evidence needed for regulatory approval, market access, and clinical adoption of therapies.

• Provide expertise on data and evidence generation solutions, considering a holistic product lifecycle perspective.

• Collaborate with internal and external partners to ensure scientific rigor in study design and analyses.

• Represent the Real-World Analytics & Innovation team in internal cross-functional teams and initiatives.

• Manage and execute Real-World Evidence (RWE) studies.

• Develop RWE study documentation in line with applicable processes.

• Publish and communicate study results in collaboration with internal partners.

• Mentor junior team members to ensure competence and development in epidemiologic skills and knowledge.

Qualifications:

• PhD, PharmD, MD, or equivalent (Education in health services research, epidemiology, biostatistics, or public health is a plus).

• 10 years of RWE-related experience, preferably in rare/complex diseases.

• Experience in applying observational research methods to RWE sources across various use cases.

• Understanding of regulatory and HTA requirements as they relate to evidence generation.

• Experience in designing and conducting observational research, including protocol writing, analysis plan, and study report development.

• Familiarity with various data sources, such as electronic medical records, registries, and/or medical claims databases is preferred.

• Advanced experience in a pharmaceutical or biotech organization is preferred, with demonstrated success working within matrixed cross-functional teams.

• Demonstrated strategic thinking and strong leadership skills.

• Ability to synthesize and convey complex data or concepts in an understandable way.

• Strong interpersonal skills.

• Ability to effectively manage projects and meet timelines.

• Excellent written and oral communication skills.