Sr. Medical Director

Sr. Medical Director

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.

Job Responsibilities

Job Summary

The Senior Medical Director provides medical and safety oversight of clinical studies interacting with customers and providing training and support to project teams to drive strong site performance and ensure subject safety and scientific integrity of clinical studies Provides therapeutic area medical input and consultation to internal colleagues and customers. Performs the duties of a Medical Monitor.

Job Responsibilities

• Provides medical oversight of assigned clinical studies in the duty as a medical monitor.

• Provides therapeutic input and consultation to customers for assigned clinical studies.

• 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.

• 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.

• Responsible for protocol design and development, upon request. Provides input into protocol amendments.

• Provides medical input and oversight in support of the Drug Safety and Pharmacovigilance department and input to clinical development or regulatory teams within the Company.

• Provides after-hours medical coverage for clinical studies.

• May oversee the work of and/or support less experienced colleagues.

• May collaborate with internal stakeholders and customers as part of the pre sales process.

• May represent the Company at scientific meetings, upon request.

• 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.

Qualifications
• Degree in medicine and significant clinical experience in the practice of medicine in specific therapeutic area. Significant clinical research and demonstrated leadership experience. Expert knowledge of drug development process, regulatory policies and procedures. Excellent written and verbal communication skills enabling effective interactions with leadership and team members, client company leaders and prospective client company leaders. Prior leadership experience required. Strong understanding of the use of medical terminology and of drug-names in multiple nations and environments is required. Demonstrated ability to lead and excel in a matrix environment. High degree of proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail. Ability to handle multiple priorities 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. Travel up to 25% may be required.

• Must demonstrate effective leadership of other medical or clinical research colleagues and proficiency with data review activities and use of various technologies utilized to display data (e.g., listings, patient profiles, customer databases and systems, and/or data visualization tools). Must demonstrate ability to contribute to consulting, commercial, regulatory, and clinical development tasks as a subject matter expert.

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.

http://www.syneoshealth.com

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.

Why Work Here

Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world. Selecting us as an employer secures a career in which you’re guaranteed to:

Collaborate with passionate problem solvers

Partner with the most diverse team of experts in the industry. From the top down, our people are inspiring. Everyone has a voice and is encouraged to use it.

• Work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration.
• We assemble clinical teams where everyone, from CRAs to senior management, is skilled in the same therapeutic area or customer teams. With this structure, everyone on your team speaks the same language and can deliver unique insights into the therapeutic environment and patient population.
• We are partners with purpose. We integrate seamlessly with our customers and do what’s best for their success. Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.