Sr. Director of Clinical Affairs

Organization
TriTek Staffing
Job Location
Lexington, MA 02420
Job Description

Job Description

Provide oversight of clinical studies performed for product registration purposes, research, and/or marketing support. Establish and maintain a global scientific program within our portfolio, to maintain a high level of scientific and clinical analysis in order to maximize the awareness and reputation of our organization.

 

Provide scientific leadership to Clinical Affairs and maintain an effective working relationship with Regulatory Affairs, R&D, and Marketing to support product registration and implementation of new products and services. Provide liaison with scientists, facilitate study implementation and assure their publication to support the corporate objectives. Maintain an effective and scientifically productive working relationship with scientific and medical thought leaders in the field.

 

Requirements

Required Skills

  • PhD in molecular biology, biochemistry, clinical science, or related field
  • 15+ years of clinical research experience within the medical device industry required.
  • Minimum of 5 years of people management experience required.
  • Experience planning, implementing, and managing medical device IVD clinical studies required. Possess the ability to write clinical trials.
  • In-depth knowledge of domestic and international regulatory requirements relating to the clinical study of medical devices/IVDs required (e.g. FDA).
  • Experience with developing clinical study protocols and with clinical site selection process.
  • Experience with electronic data capture systems.
  • Experience with biostatistics
  • Demonstrated leadership and proven ability to motivate and lead teams/colleagues to meet objectives.
  • Proven ability to develop collaborative relationships with internal and external stakeholders.
  • Proven experience selecting and managing clinical research organizations.
  • Excellent communication skills (verbal and written); proven ability to work effectively with clinical practice thought leaders.
  • Strong organizational and interpersonal skills.
  • Demonstrable budget planning, project management and creative problem solving skills.
  • Hands-on capability in all areas of clinical trial execution.
  • Experience writing scientific, clinical summary reports for regulatory submissions.
  • Demonstrated skill in clinical research as evidenced by clinical publications and/or industry experience as evidenced by successful management of and participation in domestic and international clinical trials and associated regulatory submissions. 

Travel: 15 – 20% travel required

Required Experience

  • Plan, manage, and execute clinical studies in support of worldwide product registrations
  • In collaboration with marketing and business development, plan, manage, and execute marketing studies
  • In collaboration with R&D, plan, manage, and execute pre-clinical studies
  • Develop clinical study strategy that supports intended use of products
  • In collaboration with Regulatory Affairs, interface with FDA and other appropriate regulatory bodies on design of clinical studies in support of intended use
  • Ensure that all clinical study work is conducted in compliance with all applicable regulations
  • Establish all appropriate standard operating procedures and guidance documents for the successful operation of clinical affairs in compliance with all applicable regulations
  • Manage interface with CROs and any other external suppliers used to support clinical trial execution
  • Develop and manage annual budgets
  • Lead and manage clinical affairs organization
  • Develop key business metrics to measure output of team
  • Establish and manage a sample acquisition program
  • Prepare clinical study reports and other technical documents as needed
How to Apply

please feel free to reach Eric Oliveira at [email protected] or 781-587-3245.

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