Medical Director, RWE Clinical Trials

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.

Job Responsibilities

Major duties of the Medical Director are outlined below:

• Medical Business Leadership
• Provides 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 Director
• Collaborates 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 study
• In 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
• Provides on call coverage for protocol queries and site support
• Provides first line contact for other study investigators and monitors regarding study related medical/safety issues and resolution of study protocol and patient eligibility issues
• Provides medical review of eCRFs and data analysis plan for clinical accuracy
• Reviews 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 study
• In 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 And WBA

Walgreens www.walgreens.com is included in the U.S. Retail Pharmacy and U.S. Healthcare segments of Walgreens Boots Alliance, Inc. Nasdaq WBA, an integrated healthcare, pharmacy and retail leader with a 170 year heritage of caring for communities. WBAs purpose is to create more joyful lives through better health. Operating nearly 9,000 retail locations across America, Puerto Rico and the U.S. Virgin Islands, Walgreens is proud to be a neighborhood health destination serving nearly 10 million customers each day. Walgreens pharmacists play a critical role in the U.S. healthcare system by providing a wide range of pharmacy and healthcare services, including those that drive equitable access to care for the nations medically underserved populations. To best meet the needs of customers and patients, Walgreens offers a true omnichannel experience, with fully integrated physical and digital platforms supported by the latest technology to deliver high quality products and services in communities nationwide.

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".

Basic Qualifications

• Bachelor's Degree and at least 8 years of experience in Medical Doctorate, Clinical Trials OR High School/GED and at least 11 years of experience in Medical Doctorate, Clinical Trials.
• MD only (licensed)
• At least five (5) years of clinical trial experience and acting as a Principal Investor on clinical trials to fulfill the FDA’s regulatory requirements for Medical Directors to oversee clinical trials.
• At least seven (7) years of experience is required which can include medical practice (hospital/clinic), academia, clinical research, or drug development direct patient care in clinical practice.
• Desire to provide input to build a new and exciting model using pharmacy for clinical trials.
• At least 5 years of experience contributing to financial decisions in the workplace.
• At least 5 years of direct leadership, indirect leadership and/or cross-functional team leadership.
• Willing to travel up to/at least 25% of the time for business purposes (within state and out of state).