[Hiring] Senior Medical Director @Syneos Health Careers

Role Description

Board Certified Sr Medical Director - Immunology (Rheumatology Exp Preferred) - Remote Based

• Provides medical oversight of assigned clinical studies in the duty as a medical monitor. Often 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. 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, and input into site feasibility evaluations.
• 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. Presents identified trends and issues, and mitigation strategies, to customers and project team members to minimize risks to subject safety or integrity of study data.
• Provides after-hours coverage for clinical studies.
• Adheres to all enterprise policies, work instructions, standard operating procedures, and project plans. Adheres to customer policies and standard operating procedures, as required in project plans.
• Maintains in-depth knowledge of FDA and worldwide drug development regulations and national and ICH Good Clinical Practice (GCP) guidelines.
• Leads medical responses to Requests for Proposals (RFPs) and Bid Defense Meetings (BDMs). May support Requests for Information (RFIs).
• Contributes to the development of product/clinical development plans and collaborates with customer and internal colleagues regarding other reports, applications, and regulatory submissions. Locates and engages external experts/consultants/advisors as necessary.
• Represents the Company at scientific and industry meetings. May publish scientific or industry related articles in industry journals, as requested.
• Mentors staff to ensure an appropriate level of understanding regarding sound treatment and research principles of specific therapeutic area. Ensures project teams consistently operate in compliance with such principles.
• Assumes line management duties as needed.

Qualifications

• Board certification in a relevant medical field.
• Experience in immunology and rheumatology preferred.
• Strong understanding of clinical trial processes and regulations.

Requirements

• Ability to provide medical oversight and consultation.
• Excellent communication and interpersonal skills.
• Experience in mentoring and training staff.
• Ability to work independently and as part of a team.

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.

Company Description

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture - where you can authentically be yourself.
• We are continuously building the company we all want to work for and our customers want to work with.