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Sr Director, Clinical Research and Development

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About the role

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SUMMARY
Effectively oversee department of physicians, medical writers and medical monitor associates to provide expertise and leadership in drug development strategy and activities to clients and to internal, multidisciplinary project teams. Manage department from a commercial and operational standpoint, achieving or exceeding budget targets. Recruit, mentor and develop staff.
 
JOB FUNCTIONS/RESPONSIBILITIES
  • *Provide effective leadership, management and oversight for the Clinical Research and Development (CRD) department.
  • *Contribute to the development of departmental budgets in collaboration with Finance and senior leadership; control costs, and manage department to achieve financial targets.
  • *Lead, develop, grow and manage scientific staff in the CRD department.
  • *Ensure the timely completion and documentation of required training for all staff in CRD
  • *Lead the development, implementation and improvement of department processes
  • As required, represent the CRD department at applicable early phase planning, oversight or review meetings related to financial forecasting, proposal strategy and costing, business development and other related areas.
  • Collaborate with other departments or IEP leadership staff to identify and contribute to opportunities for process improvement
  • *Resolve critical issues within CRD, and in collaboration with other departments as applicable, related to resourcing, quality, processes, timelines of client deliverables, relationships and satisfaction.
  • Serve as Scientific Team Leader and/or Clinical R&D team member on multidisciplinary project teams
  • Serve as the medical monitor for clinical studies
  • Review and interpret data and analyses from clinical studies, including raw data files, summary tables, figures and listings
  • Write, review, edit and QC applicable documents, including client proposals, synopses, protocols, amendments, reports, narratives, investigator brochures, informed consent forms, manuscripts, clinical development plans and analysis plans, that meet client needs and scientific and regulatory standards as applicable
  • Oversee, participate or assist in the planning and conduct of DSMB, Safety Review, Cohort Review, Dose Escalation, Data Review committees or other study-related meetings
  • Prepare and participate in scientific and capability presentations for prospective clients (Business Development, Bid Defense) and for presenting at conferences and professional meetings. Collaborate with Business Development on client identification and development for new projects.
  • Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
  • As a Manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
  • Travel (approximately 10-15%) domestic and/or international.
 
SUPERVISION
  • Recruit and retain a high performing CRD team
  • Provide vision, leadership, coaching and mentorship to CRD staff
  • Ensure CRD staff operate in a professional and client-oriented manner to maintain positive strong working relationships with clients and internal staff
  • Assist staff with development and completion of performance goals, and conduct regular performance appraisals and provide constructive feedback so staff can improve their performance
Ensure all necessary training is provided to staff to improve their job performance and knowledge
 
EXPERIENCE, SKILLS, KNOWLEDGE REQUIREMENTS
  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • A minimum of 8 years of similar relevant experience in leading clinical pharmacology, early clinical drug development (phase 1-2a), clinical research, regulatory science and preparing applicable clinical research documentation, with a substantial amount of that experience being in healthy volunteer (clinical pharmacology) studies such as: First-in-Human (FIH), Single Ascending Dose (SAD), Multiple Ascending Dose (MAD), Pharmacokinetic (PK), Pharmacokinetic-pharmacodynamic (PK-PD), Bioavailability/Bioequivalence (BA/BE), biosimilar, Food Effect (FE), Drug-Drug Interaction (DDI), Thorough QT (TQT), renal impairment and hepatic impairment, as well as proof-of-concept (POC) and early patient studies. Most of this experience should be in small molecules, with additional experience in biologics/vaccines/devises a plus. Prefer this experience in a CRO environment and/or Pharmaceutical Company.
  • Excellent interpersonal and leadership skills; ability to plan/organize and multi-task
  • Excellent staff supervision, motivation and development skills
  • Knowledge of scientific and regulatory requirements applicable to early phase clinical studies
  • Excellent clinical data interpretation and verbal and written communication skills
  • Excellent computer skills to include MS Word, Excel, PowerPoint
  • Medical license or equivalent is preferred
  • Due to the nature of this position it may be required for the employee to travel.  Therefore, dependent on the employee’s location, the employee may be required to possess a valid Driver’s license.
 
EDUCATION
**MD/DO /MB ChB, MB BS or other Doctorate medical degree or local equivalent.
Board certified or eligible (or equivalent) in a primary care medical specialty (internal medicine, pediatrics, family practice) is preferred.
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