This position will design, plan and execute clinical trials, from leading the development of clinical plans to driving through clinical studies. You will identify needs, contingencies and operational plans, while also ensuring strategic positioning is in line with company goals. Specific responsibilities include:
o Write and/or facilitate the writing of clinical project management documents such as project scope definition documents, project training materials, monitoring plans and monitoring tools, study protocols, safety plans, recruitment plans and closeout plans, etc.
o Coordinate/execute operational aspects of assigned clinical studies (including identification, selection, qualification and management of clinical investigators and third party vendors, test article release to sites, site monitoring activities, ongoing review of key study data, etc.).
o Review and approve monitoring reports and follow-up letters prepared by the project CRAs for assigned studies.
o Plan and review the analysis of clinical data and determine the ultimate interpretation of results.
o Ensure the assigned trials are “audit ready” at all times (project team training records, current regulatory documents, appropriate IRB approvals, monitoring tools required for the trial). Ensure that any audit observations are addressed appropriately and in a timely manner.
o Develop and maintain project schedules, with key metrics, for clinical projects to ensure optimal study management. Identify and resolve issues that impact project scope, resources. or timelines and communicate to senior management.
o Develop and monitor overall clinical development budget for assigned projects ; effectively manage resources, funding and expenses.
Assist with tracking and forecasting resource capacity and utilization to ensure that required clinical development resources are available when needed and optimally utilized.
• Provide therapy area medical and scientific expertise to study teams and key stakeholders.
• Anticipate trends in medicine and industry that may/will have an impact on the clinical/commercial viability of products and factors into planning.
• Serve as principal medical monitor overseeing all aspects of the safety monitoring in the clinical development programs.
• Prepare clinical sections of regulatory documents such as investigator brochures, INDs, NDAs, BLAs, background packages for FDA meetings, etc. Provide medical review and approval of regulatory documents pertaining to the work of the clinical team.
• Cultivate and nurture strong collaborations with key opinion leaders, Investigators, research centers and corporate partners.
• Collaborate with Business Development, Senior R&D and Commercial leadership to identify, recommend and develop strategic alliances, partnership and licensing opportunities requiring due diligence work and strategic input.
• Engage and inspire the project/clinical development team through communicating the strategic vision and the operational plan to achieve the vision.
• MD and US medical license, with 14+ years of clinical drug development related experience in the research and development of novel biologics, particularly within the field of inflammation.
• Expertise in preclinical, translational and early clinical development within the field of inflammation
• Extensive academic and pharma collaborative network. History of personal interaction with thought leaders in the inflammation field.
• Track record of program leadership and achievement of goals and deliverables, of effective collaboration, effectiveness in team settings, and team leadership
• Firm understanding of the mechanistic basis of human inflammatory disorders
• Thorough understanding of clinical protocols and regulatory processes.
• Excellent understanding of the drug development process
• Thorough knowledge of FDA requirements, Good Clinical Practices, and pharmaceutical clinical development.
• Demonstrated success establishing, communicating and driving a vision and strategy for a therapeutic area/product, and develop an integrated plan of action including milestones and endpoints and ensure executional excellence.
• The ability to think globally, strategically and innovatively about the future of the disease state and company’s therapeutic agents and possess a solid understanding of the pharmaceutical industry, company competition and commercial side of business, including Marketing and Sales, Market Access, Pricing/Reimbursement, Business Development, Medical Affairs and Supply Chain.
• Effective communication and interpersonal skills, with the ability to successfully articulate strategies, experimental results and analysis to various constituents such as governance committees, project teams, clinical sub-teams, and senior management to build enthusiasm, passion and commitment, and to gain approval /sponsorship for projects.
• Ability to work effectively in as a team player in a complex, changing environment, with the ability to build morale and group commitments to goals and objectives.
• Ability to garner support for projects and recommendations through on-going collaboration, open and influential communications and commitment to improvement/change.
• Position will require domestic and international travel