Executive Director, Early Medical Development
Job 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.
At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a 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, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.
Salary Range:
$193,600.00 - $367,800.00
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 candidate27s qualifications, skills, competencies, and proficiency for the role.
Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
