Medical Director, RWE Clinical Trials - Remote
Walgreens
Job Summary
Walgreens RWE Clinical Trials is seeking an experienced Medical Director role to provide medical oversight and leadership serving as Principal Investigator and Medical Monitor for clinical trials on behalf of Pharmaceutical (Sponsor) companies. The candidate will have a strong background in clinical research, a deep understanding of regulatory requirements, and experience with innovative trial designs and technologies. The role will also require the need to interface with Sponsor medical teams and collaborate with the RWE Commercial team on pre-sales activities to win new clinical trials for the business.
Major duties of the Medical Director are outlined below:
Job Responsibilities:
Medical Business LeadershipProvides medical and scientific leadership for clinical trial design, protocol development, and execution including review of new business proposals, clinical trial data, feasibility analysis, study protocols, training materials, informed consent, eCRFs, analysis plan designs, clinical study reports, regulatory approval submissions, serious and non-serious adverse event evaluation and reporting.Oversees the development of clinical study reports, publications, and presentations.Ensures the scientific integrity and patient safety in compliance to the FDA and ICH/GCP guidelines for clinical trials.Participate in new business development activities including proposal writing and RFP responses, providing medical and scientific input.Serves as the external clinical trials medical leader to meet with Pharma and at Investigator meetings.Assist in developing strategic partnerships with technology providers, CROs, and other industry stakeholders.Establishes and maintains a network of medical/scientific Principal Investigators and other medical associates (in house or external contractors)Supervises and manages Medical Director activities conducted by staff reporting into the Medical DirectorCollaborates with medical group leadership on governance, policy and procedure development, clinical integrity, compliance, quality satisfaction and coordination initiatives, and related activities from time to time
Principal Investigator (Billable)Serve as the licensed and approved Principal Investigator (PI) for the Walgreens’ clinical trials.Verifies the medical accuracy of patient safety data and maintains an ongoing assessment of the safety profile of the studyIn consultation with the sponsor, follow procedures for acquiring knowledge of subject treatment assignments (i.e. breaking the blind)Interact with appropriate FDA officials concerning safety and other study related issues, as requestedProvides on call coverage for protocol queries and site supportProvides first line contact for other study investigators and monitors regarding study related medical/safety issues and resolution of study protocol and patient eligibility issuesProvides medical review of eCRFs and data analysis plan for clinical accuracyReviews safety fields at case freeze for reconciliation (if needed)Engages in medical group leadership activities to build-out Principal Investigator functional capabilities
Medical Monitoring and SAE Reporting Activities:Verifies the medical accuracy of patient safety data and maintains an ongoing assessment of the safety profile of the studyIn consultation with the sponsor, follow procedures for acquiring knowledge of subject treatment assignments (i.e. breaking the blind)Interact with appropriate FDA officials concerning safety and other study related issues, as requested.
About Walgreens
Founded in 1901, Walgreens (www.walgreens.com) has a storied heritage of caring for communities for generations, and proudly serves nearly 9 million customers and patients each day across its approximately 8,500 stores throughout the U.S. and Puerto Rico, and leading omni-channel platforms. Walgreens has approximately 220,000 team members, including nearly 90,000 healthcare service providers, and is committed to being the first choice for retail pharmacy and health services, building trusted relationships that create healthier futures for customers, patients, team members and communities.
Walgreens is the flagship U.S. brand of Walgreens Boots Alliance, Inc. (Nasdaq: WBA), an integrated healthcare, pharmacy and retail leader. Its retail locations are a critical point of access and convenience in thousands of communities, with Walgreens pharmacists playing a greater role as part of the healthcare system and patients’ care teams than ever before. Walgreens Specialty Pharmacy provides critical care and pharmacy services to millions of patients with rare disease states and complex, chronic conditions.
The actual salary an employee can expect to receive, plus bonus pursuant to the terms of any bonus plan if applicable, will depend on experience, seniority, geographic location, and other factors permitted by law. To review benefits, please visit jobs.walgreens.com/benefits.
"An Equal Opportunity Employer, including disability/veterans".
#LI-TO1
Walgreens RWE Clinical Trials is seeking an experienced Medical Director role to provide medical oversight and leadership serving as Principal Investigator and Medical Monitor for clinical trials on behalf of Pharmaceutical (Sponsor) companies. The candidate will have a strong background in clinical research, a deep understanding of regulatory requirements, and experience with innovative trial designs and technologies. The role will also require the need to interface with Sponsor medical teams and collaborate with the RWE Commercial team on pre-sales activities to win new clinical trials for the business.
Major duties of the Medical Director are outlined below:
Job Responsibilities:
Medical Business LeadershipProvides medical and scientific leadership for clinical trial design, protocol development, and execution including review of new business proposals, clinical trial data, feasibility analysis, study protocols, training materials, informed consent, eCRFs, analysis plan designs, clinical study reports, regulatory approval submissions, serious and non-serious adverse event evaluation and reporting.Oversees the development of clinical study reports, publications, and presentations.Ensures the scientific integrity and patient safety in compliance to the FDA and ICH/GCP guidelines for clinical trials.Participate in new business development activities including proposal writing and RFP responses, providing medical and scientific input.Serves as the external clinical trials medical leader to meet with Pharma and at Investigator meetings.Assist in developing strategic partnerships with technology providers, CROs, and other industry stakeholders.Establishes and maintains a network of medical/scientific Principal Investigators and other medical associates (in house or external contractors)Supervises and manages Medical Director activities conducted by staff reporting into the Medical DirectorCollaborates with medical group leadership on governance, policy and procedure development, clinical integrity, compliance, quality satisfaction and coordination initiatives, and related activities from time to time
Principal Investigator (Billable)Serve as the licensed and approved Principal Investigator (PI) for the Walgreens’ clinical trials.Verifies the medical accuracy of patient safety data and maintains an ongoing assessment of the safety profile of the studyIn consultation with the sponsor, follow procedures for acquiring knowledge of subject treatment assignments (i.e. breaking the blind)Interact with appropriate FDA officials concerning safety and other study related issues, as requestedProvides on call coverage for protocol queries and site supportProvides first line contact for other study investigators and monitors regarding study related medical/safety issues and resolution of study protocol and patient eligibility issuesProvides medical review of eCRFs and data analysis plan for clinical accuracyReviews safety fields at case freeze for reconciliation (if needed)Engages in medical group leadership activities to build-out Principal Investigator functional capabilities
Medical Monitoring and SAE Reporting Activities:Verifies the medical accuracy of patient safety data and maintains an ongoing assessment of the safety profile of the studyIn consultation with the sponsor, follow procedures for acquiring knowledge of subject treatment assignments (i.e. breaking the blind)Interact with appropriate FDA officials concerning safety and other study related issues, as requested.
About Walgreens
Founded in 1901, Walgreens (www.walgreens.com) has a storied heritage of caring for communities for generations, and proudly serves nearly 9 million customers and patients each day across its approximately 8,500 stores throughout the U.S. and Puerto Rico, and leading omni-channel platforms. Walgreens has approximately 220,000 team members, including nearly 90,000 healthcare service providers, and is committed to being the first choice for retail pharmacy and health services, building trusted relationships that create healthier futures for customers, patients, team members and communities.
Walgreens is the flagship U.S. brand of Walgreens Boots Alliance, Inc. (Nasdaq: WBA), an integrated healthcare, pharmacy and retail leader. Its retail locations are a critical point of access and convenience in thousands of communities, with Walgreens pharmacists playing a greater role as part of the healthcare system and patients’ care teams than ever before. Walgreens Specialty Pharmacy provides critical care and pharmacy services to millions of patients with rare disease states and complex, chronic conditions.
The actual salary an employee can expect to receive, plus bonus pursuant to the terms of any bonus plan if applicable, will depend on experience, seniority, geographic location, and other factors permitted by law. To review benefits, please visit jobs.walgreens.com/benefits.
"An Equal Opportunity Employer, including disability/veterans".
#LI-TO1
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