Director of Clinical Development & Operations in Norwalk, CT at Apex Life Sciences

Date Posted: 11/9/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Norwalk, CT
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    11/9/2018
  • Job ID:
    912630

Job Description


The Director of Clinical Development & Operations will oversee the direction, planning, execution, and interpretation of clinical trials/research and the data collection activities. The Director will establish and approve the scientific methods for design and implementation of clinical protocols, data collection systems and final reports. In conjunction with the Executive Team, this individual will recruit clinical investigators and negotiates study design and costs. They will be responsible for directing oncology clinical trials studies; phases I through IV. Responsibilities also include adverse event reporting and safety responsibilities monitoring. The Director will coordinate and develop reporting information for reports submitted to the Executive Team and the Board of Directors. They will have overall responsibility for adherence to protocols and determines study progress, results and completion.

Essential Functions  Finance to coordinate clinical billings, budgets, forecasts as well as process and approve invoices from participating institutions.

  • Set project timelines and enrollment goals and complete studies on a timely basis with any delays communicated to the management team. 
  • Design and optimize clinical trial design and ensure clinical trials meet ethical and regulatory standards.
  • Ensure that clinical trials programs and activities align and comply with the organization’s timelines and budget goals.
  • Ensure the effective communication of information between several key groups; provide updates on trial activities to ensure that clinical trial milestones are accomplished.
  • Set priorities and ensure the efficient operations of clinical activities 
  • Conduct medical review and interpretation of efficacy and safety data from clinical trials.
  • Coordinate patient e care, pools, treatment, and portals.
  • Identify and cultivate new revenue streams and patient pool involvement. 
  • Develop, maintain and comply with the organization’s clinical and research policies and procedures; comply with all relevant regulations and laws; ensure accountability to scientists and physicians; and comply with codes of ethical principles and standards of professional conduct for medical executives.
  • Ensure the sound fiscal operation of research/clinical trial function, including the timely, accurate and comprehensive development of drugs, reporting, monitoring, variance analysis and phase development.
  • Establish and maintain working relationships with study investigators, key opinion leaders, academicians, and  Executive Team and department leaders across the organization.
  • Direct the development of publications arising from study results and other relevant information.

Competencies:

  • Extensive experience in leading clinical trial operations (planning and execution), in both pharmaceutical and academic environments, with experience as study manager, clinical site monitor and study coordinator.
  • Clinical study management; strong scientific/technical skills and knowledge.
  • Demonstrated ability to identify and cultivate new revenue streams and patient pool involvement.
  • Project management skills with demonstrated ability to plan and execute strategic and operational projects with a focus on delivering results.
  • Able to motivate a team of highly skilled and knowledgeable individuals; experience providing study management process, operational training and mentoring.
  • Excellent interpersonal capabilities with the ability to build networks and manage cross-functional efforts and teams; promotes open communication to foster teamwork and deliver results.
  • Excellent verbal communication and technical writing skills that translate into effective reasoning.
  • Clinical site monitoring; expert in monitoring report development.
  • Ability to present clearly using clinical and scientific terminology while still being compelling.
  • A strong sense of urgency to drive innovation and results.
  • Sound judgment and organizational skills

Qualifications:

  • A Bachelor’s Degree required.
  • A Master’s Degree and advanced training in Hematology and Oncology strongly preferred.
  • Minimum of 5 years in medical practice/industry; prior oncology experience strongly preferred.
  • Robust understanding of GCP, ICH and FDA requirements; FDA Part 11 validation and compliance.
  • Experience developing and implementing comprehensive drug development, and clinical trial research, Preclinical – Phase II programs with successful results; Drug phase I-IV development knowledge a plus.
  • Comfortable with large site load; previous experience in managing several clinical research organizations involved in multiple on-going clinical trial studies over several sites with successful results.
  • Solid people management with exceptional skills in decision-making, influencing, leadership and effecting change by a collaborative management approach.
  • Budgeting and resource management experience.
  • Exceptional communication skills, both written and verbal.
     

Core Customers and Key Relationships

  • Patients
  • Researchers
  • Key opinion leaders
  • Regulators
  • Donors

To apply for this position please send your resume to Vickie Dagit at vdagit@apexlifesciences.com, 919-334-0178

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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