Executive Director, Medical Development (MD)
Proclinical is currently recruiting for an Executive Director of Medical Development with a biotechnology company located in San Diego, CA. Successful candidate will be responsible for the design, plan and execution of clinical trials, and running of programs focused on assigned therapeutic areas, in accordance with applicable regulatory and quality standards, and company timelines and budgets.
- Lead the development and execution of clinical plans to drive programs through clinical studies. Identify needs, contingencies and operational plans, while also ensuring strategic positioning is in line with company goals.
- Lead the clinical development team, in close collaboration with all involved line functions such as operations, regulatory etc., of designated clinical studies.
- Provide strategic input on new indications and/or opportunities for antibodies already in development as well as for novel antibodies entering the clinic
- Work closely with the discovery team helping in the identification of novel targets
- 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.
- 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.).
- Review and approve monitoring reports and follow-up letters prepared by the project CRAs for assigned studies.
- Plan and review the analysis of clinical data and determine the ultimate interpretation of results.
- 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.
- 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.
- 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.
Skills and Requirements:
- 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.
- Experience with Microsoft Word, Excel, PowerPoint, Outlook, Adobe, and Internet Explorer.
- 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.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Divya Mistry at (+1) 646-630-9650 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.