Director Clinical Research

Company: Fladger Associates
Location: Durham
Posted on: September 24, 2022

Job Description:

Gaithersburg, MD or Durham, NC Contract Duration: 12-36 months Rate: Negotiable Responsibilities:

• Excellent employment opportunity for a Director Clinical Research in the Gaithersburg, MD or Durham, NC.
• Can be a hybrid situation with up to 50% remote work.
• Possibly open to remote/virtual arrangements for strong candidates, but candidates must be within driving distance from Gaithersburg or Durham and able to come onsite regularly for meetings.
• Renowned expert in own field and may specialize in more than one area.
• Works independently with guidance in only the most complex situations.
• May coordinate the activity of a research team and holds full accountability for projects, often with Global impact.
• Will work in a global role within the Clinical Operations function of Late Stage RandD (Biopharmaceuticals).
• The span of responsibilities is broad and may support one or several products depending on their size and complexity.
• The products supported may include studies in all phases of drug development.
• Responsible for oversight of a program of global studies, covering all clinical development deliverables (including aspects of quality, budget, time, resource and risk).
• Also involves integrating design, feasibility and operational planning to ensure clinical drug development programs are aligned with priorities and strategy.
• Provide input and support to the Senior Global Clinical Operations Program Director in preparation for new business case opportunities for review by governance interactions and may act as the lead for cross-functional teams in delivery of various clinical activities and manage improvement or change projects within clinical operations or spanning multiple business areas.
• Lead cross functional teams of experts in the planning and delivery of a defined clinical program of studies and/or clinical activities to scope, quality, budget, time, planning the resource and managing risk.
• Work closely with global study leaders to provide appropriate strategic oversight of a program of studies on behalf of Sr Global Clinical Operations Program Director and Clinical Program Team (CPT).
• Responsible for providing clinical operations expertise into the development of new business case opportunities for review by governance.
• Lead cross functional Clinical Submission Teams in planning and execution of clinical contribution to Marketing Applications, maintenance support for regulatory interactions and reports and inspection readiness.
• Lead large or complex deliverables and the process to identify and solve or raise operational issues.
• Drive delivery to plan through internal or external partners (alliance partners, Clinical Research Organizations (CROs), vendors and Academic Research Organizations (AROs)). Experience:
  • Bachelor's Degree (or equivalent), preferably in Medical or Biological Sciences or subject area associated with Clinical Research.
  • At least 10 years' experience from within the Pharmaceutical industry or similar large multinational organization and proven experience of clinical development / drug development process in various phases of development and therapy areas.
  • Experience from leading clinical projects and deliverables or similar expertise from other areas of drug development (such as Pharmaceutical development) and proven knowledge of project management tools and processes.
  • Proven leadership promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives.
  • Ability to mentor, develop and educate staff.
  • Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills. Job Requirements:BIOLOGICAL SCIENCES, pharmaceutical, DRUG DEVELOPMENT, project management tools, clinical research, clinical development, Medical

Keywords: Fladger Associates, Durham , Director Clinical Research, Executive , Durham, North Carolina