Senior Director, Immunology Epidemiology Pipeline
Syneos Health, Inc.
Dir, Epidemiology Pipeline (TA-Immunology) 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 JOIN OUR TALENT NETWORK. This position is part of an ongoing talent pipeline; while there is no immediate opening, qualified candidates will be considered as opportunities become available. *Looking for SME in Immunology Clinical Trials -Serves as a scientific resource for RWLP management, Company senior management, and other Functions within Company providing expertise in multiple scientific areas. * Works hand-in-hand with RWLP management, business development, and operations personnel to develop and win global business opportunities; helps to lead the development and delivery of project proposals, bid defenses, and represents capabilities presentations.- Provides overall scientific oversight of selected projects, responsible for meeting or exceeding customer expectations for timelines, budgets, quality, and overall satisfaction.
- Coordinates with the project manager to oversee the scientific aspects of study start-up and ongoing study management. Leads the development of and/or peer-review essential study documents including the protocol, case report forms, statistical analysis plan, study management plans, and interim/final study reports. Facilitates scientific advisory boards for safety studies and produces scientific reports/manuscripts/abstracts/presentations.
- Maintains a strong working understanding of clinical and epidemiological practice guidelines, clinical research models, protocol designs, real-world research development trends, and regulatory expectations and develops trainings for RWLP/Company organization to enhance their familiarization of epidemiologic study designs and applicable guidelines.
- Responsible for the continued building of organizational capacity, improvement of scientific and operational processes and methodologies for non-traditional site management tasks (i.e., remote or central monitoring approaches, minimized regulatory document collection, etc.), integrated RWLP technology solutions including secondary database resources, and RWLP Standard Operating Procedures (SOP) development and maintenance.
- Works collaboratively across the organization to help develop business opportunities in the area of post marketing safety commitments and/or risk management; develops and recommends techniques to improve productivity, increase efficiencies, cut costs, take advantage of opportunities, and maintain state-of-the-art practices.
- Works to develop collegial relationships with sponsors, thought-leaders and clinical investigators.
- Develops abstracts, provides podium presentations, and leads authorship of articles, manuscripts, etc. in industry and peer-reviewed journals to promote Company services.
- SME in Immunology Clinical Trials
- Requires graduate degree in Epidemiology, Statistics, or Public Health; (Masters; Preferred Doctorate);
- Requires in-depth knowledge of and experience with a variety of study designs; familiarity with post-marketing and late phase study designs as well as relevant guidelines preferred;
- Requires basic knowledge of statistical programming language(s) (e.g., SAS, R, Python);
- Excellent communication, presentation, both written and spoken;
- Strong personal communication and team-oriented skills;
- Demonstrated leadership and technical skills.
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