Medical Director (preferably with Oncology)

Medical Director (preferably with Oncology)

inVentiv Health Clinical SRE, LLC
Not Specified
Not Specified

Job Description


Job Description :
Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of.
As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors.
Why Syneos Health
    #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference. We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. 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.

Summary:
Interacts with senior management, customers, and project teams to ensure the safety of subjects in clinical trials ensures the scientific integrity of the clinical portions of clinical trials provides medical input to clinical programs provides clinical development and regulatory consulting advice as needed. Performs the duties of a Medical Monitor.
Essential Functions:
    Manages subject safety and the scientific integrity of clinical trials. Responsible for subject-safety and the scientific integrity of clinical trials. Performs the duties of a Medical Monitor. Provides 24-hour coverage for clinical trials. Participates in bids, bid-defenses & feasibility assessments when requested. Provides project-specific and therapeutic training to sponsors and Company staff as needed. Works with the Drug Safety Department by providing medical input and oversight. Works with Medical Writing/Regulatory in the preparation of a variety of documents as required. Maintains in-depth knowledge of worldwide drug development regulations and Good Clinical Practice (GCP) guidelines. Interacts with senior management, project management, and other departments as appropriate. Provides clinical development and regulatory consulting advice both within Company and to clients as requested. Locates and interacts with outside experts as necessary. Provides feedback to management on quality issues within the clinical trial team Represents Company at scientific meetings as required. Primary senior-level contact for customers. Assumes line-management duties as needed.
Qualifications
Requirements:
    A doctoral-level degree in medicine and must have practiced medicine and have clinical research experience. In-depth knowledge of FDA and worldwide drug-development regulations. Strong understanding of the use of medical terminology and of drug-names in multiple nations, cultures and environments. In-depth knowledge of national and ICH Good Clinical Practice (GCP) guidelines. Basic computer and word-processing skills, including the use of spreadsheets, e-mails and smart-phones. Experience working in matrix-teams. Ability to handle multiple tasks to meet deadlines in a dynamic environment. Effective organizational and interpersonal skills. Skilled at presenting data to groups, and in the creation of effective documentary communication. Customer-focused with a disciplined approach to work with excellent verbal communication and language skills. Fluency in written and spoken English.

Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. 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.

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