Role Description
The Medical Director (HIV Research Scientific Lead - Clinical/Observational Research) provides medical oversight of assigned clinical studies in the duty as a medical monitor. Responsibilities include:
-
Serves as primary medical contact for customers for assigned clinical studies.
-
Provides medical input and oversight in support of the Drug Safety and Pharmacovigilance department.
-
Responsible for protocol design and development, upon request, and provides input into protocol amendments.
-
Develops and delivers project-specific and therapeutic training to project team members and clinical site staff; provides training to customer staff as needed.
-
Provides medical and therapeutic input to Study Start Up, Feasibility, and Subject Identification efforts, including review of Informed Consent Templates and Subject-Facing Materials.
-
Provides medical input into data collection tools, monitoring plans, and review and analysis plans.
-
Provides oversight to assigned Medical Scientist staff and Medical Director colleagues to review clinical data, presenting identified trends and issues, and mitigation strategies to customers and project team members.
-
Provides after-hours medical coverage for clinical studies.
-
Adheres to all enterprise policies, work instructions, standard operating procedures, and project plans.
-
Maintains in-depth knowledge of FDA and worldwide drug development regulations and national and ICH Good Clinical Practice (GCP) guidelines.
-
May support responses to Requests for Proposals (RFPs) or Bid Defense Meetings (BDMs), upon request.
-
May provide input to clinical development or regulatory teams within the Company, upon request.
-
May represent the Company at scientific meetings, upon request.
Qualifications
-
Doctorate degree in medicine and clinical experience in the practice of medicine in the specific therapeutic area.
-
Clinical research experience required.
-
In-depth knowledge of FDA and worldwide drug development regulations.
-
Strong understanding of the use of medical terminology and of drug names in multiple nations and environments.
-
Experience working in matrix teams is preferred.
-
Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail.
-
Effective organizational and interpersonal skills, communication and language skills, and group presentation skills.
-
Above average attention to detail, accuracy, organizational, interpersonal, and team-oriented skills.
-
Ability to handle multiple tasks to meet deadlines in a dynamic environment is essential.
-
Ability to be customer-focused and have a disciplined approach to work is critical.
-
Fluency in written and spoken English is essential.
-
Up to 25% travel may be required.
Benefits
-
Company car or car allowance.
-
Health benefits including Medical, Dental, and Vision.
-
Company match 401k.
-
Eligibility to participate in Employee Stock Purchase Plan.
-
Eligibility to earn commissions/bonus based on company and individual performance.
-
Flexible paid time off (PTO) and sick time.
Salary Range
$146,000.00 - $277,000.00. The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidateβs qualifications, skills, competencies, and proficiency for the role.