Description
Medical Director
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
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 accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
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 our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
Job Responsibilities
- 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. 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 medical 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.
- 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
What we’re looking for
Doctorate degree in medicine and clinical experience in the practice of medicine in the specific therapeutic area. Clinical research experience required. Candidate must have in depth knowledge of FDA and worldwide drug development regulations. A strong understanding of the use of medical terminology and of drug names in multiple nations and environments is required. 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.
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
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. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
