Drug Safety Temp Director, Pharmacoepidemiology - Remote New Jersey

Orbis Clinical is seeking a remote-based Temp Director, Pharmacoepidemiology for 6 months initial contract.

Job Title: Temp Director, Pharmacoepidemiology

Location: Remote

Contract: 6 months initial

We use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Temp-Director Pharmacoepidemiologist join our Patient Safety team. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

• Work Location: Remote-United States
• Periodic travel may be required

Summary/Position Objective:

The Pharmacoepidemiologist with qualifications commensurate with the Director level will be accountable for development and implementation of pharmacoepidemiology strategy in the designated therapeutic area (TA), leading cross-functional project teams and epidemiology activities such as regulatory agency-required epidemiologic studies and generation of epidemiology data to support clinical development and regulatory filings and approval, in accordance with global regulations and company’s SOPs and working practices. The Pharmacoepidemiologist will serve as an in-house subject matter expert in epidemiology to other departments. The candidate should be knowledgeable in the latest epidemiologic methods and resources to be able to be responsive within cross functional teams and to influence decision making where needed.

Job Duties:

Under supervision of the Pharmacoepidemiology Therapeutic Area (TA) lead for Oncology:

• Responsible for pharmacoepidemiology strategy generation of real-world evidence (RWE), and conduct of regulatory agency required epidemiologic studies for post-marketing commitments (e.g., PASS, PAES, PMR, DUS, effectiveness of REMS and RMMs) in support of clinical development, regulatory filings, and post-marketing requirements
• As a subject matter expert, contribute to other pharmacoepidemiology activities, including but not limited to: (Development) Risk Management Plans; Benefit-Risk analyses; signal management; responses to regulatory agency queries; regulatory filings
• Working closely with Global Patient Safety (GPS) Leads, Safety Scientists, Clinical Scientists, Regulatory Affairs and other functions, provide timely epidemiological and risk management strategy and support to project and product teams of TAs including design, implementation and data analysis of epidemiological studies, review of study proposal from internal and external sources, and database activities such as exploring external electronic, patient-level database(s) (administrative claims/EMR/surveys/registries etc) to evaluate safety/benefit questions, mortality and morbidities/comorbidities, and other appropriate epidemiologic data in support of clinical development and regulatory filings
• Represent Pharmacoepidemiology on cross-functional teams, including Safety Monitoring Teams (SMT), Clinical Study Teams (including with external partners), Company Safety Oversight Committee, and Independent Data Monitoring Committees
• Proactively lead non-compound specific pharmacoepidemiology activities (ex. literature review and database queries in support of regulatory filling)
• Actively drive and participate in the development and maintenance of relevant SOPs and Working Instructions
• Actively drive and participate in process improvement activities and strategic initiatives GPS and across the company, as appropriate
• Manage contractors, and external vendors, as appropriate.
• Develop and maintain professional relationships and collaborations with external experts and opinion leaders to ensure high quality evidence generation

Job Requirements:

• Proven history as a subject matter expert in the field of pharmacoepidemiology, and ability to represent the function both internally and externally
• Up-to-date knowledge of US and international regulatory guidance’s (e.g., pharmacovigilance, RWE, good epidemiology practices) and ability to apply this knowledge to pharmacoepidemiology activities throughout the product life-cycle.
• Experience utilizing automated healthcare databases (internal and large external databases) to support pharmacoepidemiologic activities
• Significant experience working with and leading/overseeing cross-functional teams and external vendors.
• Proven track record of leadership (e.g., people management and/or project management)
• Excellent written and verbal communication skills

Education:

• MD, PharmD, plus other post-graduate degree in epidemiology or a related field (e.g. MPH, MSc)
• Doctoral degree in epidemiology or a related field, generally with 5+ years of post-doctoral experience, including 3+ years of industry/regulatory experience.
• Other post-graduate degree in epidemiology or a related field (e.g. MPH, MSc), generally with 8+ years of experience including 5+ years of industry/regulatory experience.
• Demonstrated achievements of increasing complexity/ responsibility.

Compensation Details:

• Orbis Clinical is an equal opportunity employer that provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.
• The Pay Range for this position is $150.00 – $170.00 per hour, can vary depending on employment status.
• Orbis Clinical offers eligible employees health benefits (medical, dental, and vision), employer-paid basic life and AD&D insurance, and a partial employer match on a 401(k). 

EEO and Reasonable Accommodation Statement:

Epic Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.

 By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.