Brief Description:  

Provide leadership, strategic direction, practical consultation and support on design and implementation of epidemiologic studies including registries, observational studies, post-authorization safety studies, and RWE and data base analyses; safety surveillance; regulatory responses, and risk management plans ex US to internal UBC teams and to biopharmaceutical clients worldwide. Contribute to the strategic growth, development, and implementation of UBC’s late stage business development activities (e.g., capabilities, presentations, proposals, bid defenses). Lead strategic  initiatives related to real world evidence (RWE) and research, including database analyses, hybrid studies, integrated studies and decentralized studies.

Specific job duties: 

Provide direction, guidance and strategic and regulatory support to, Clinical Operations, and RWE teams.Design strategic approaches and protocols for observational studies, registries and RWE studies of all designs, and strategic approaches to safety issues in response to regulatory requirements Consult with clients worldwide on the strategy, design, implementation, and analysis of risk management programs ex-US, including interface with EMA and PRAC.Serve as UBC representative to the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP).Provide strategic direction to observational study teams and lead strategy , analysis and writing of EU Risk Management Plans.Author protocols, reports and other study documents as well as manuscripts.  Ensure quality and completeness of end products.

Desired Skills and Qualifications:

Ability to establish and execute goals and objectives for functional areas within Evidence development solutions (EDS). Excellent written and verbal communication skills.Excellent interpersonal skills. Medical degree or Doctorate level preferredMinimum of 10 years of work experience in the biopharmaceutical industry Knowledge of global regulatory requirements for epidemiologic programs, RWEIn-depth knowledge of study design for clinical trials, observational studies and RWE database studies

UBC is proud to be an equal opportunity employer and does not discriminate because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state, or local protected class. We are committed to a diverse, equitable and inclusive culture that fosters respect for each other, our clients, and our patients.

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