Executive Director, Early Medical Development
About The Position
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. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health • 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. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.
Requirements
- Maintains in-depth knowledge of FDA and worldwide drug development regulations and national and ICH Good Clinical Practice (GCP) guidelines.
Responsibilities
- Operates as a subject matter expert in one or more indications.
- Supports talent identification, hiring, development and management of key medical staff needed to meet the strategic needs of the BU. Manages multiple individuals, frequently supervising multiple levels of staff.
- Serves as the Medical Lead in governance activities at the asset level or portfolio level, characterized by strong peer-to-peer working relationship with senior medical personnel within customer companies and strategic planning and problem-solving skills to deliver clinical studies and programs to customer satisfaction.
- Leads interdivisional (Clinical) and cross-divisional (Clinical, Commercial and Consulting) activities in support of corporate objectives, as assigned, in support of innovative business development opportunities with client companies.
- Provides medical oversight of assigned clinical studies when assigned as a medical monitor. Serves as primary medical contact for customers for assigned clinical studies and as the functional lead for medical colleagues:
- 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. This activity includes, but is not limited to, 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 to 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 Requests for Information (RFIs) and formulates winning strategies for Bid Defense Meetings (BDMs) as a recognized Thought Leader. Teaches and supervises other medical staff to conduct these activities.
- 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.
- Participates in BU or cross-functional process improvement initiatives, upon request, and may self-identify initiatives and innovations to advance the mission of the BU.
Benefits
- company car or car allowance
- Health benefits to include 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
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What This Job Offers
Job Type
Full-time
Career Level
Executive
Education Level
No Education Listed
