Dir, Epidemiology Pipeline (TA-Immunology)

Syneos Health

1d

About The Position

Syneos Health is a leading fully integrated biopharmaceutical solutions organization focused on accelerating customer success. This position is part of an ongoing talent pipeline, and qualified candidates will be considered as opportunities become available. The role is for a Director, Epidemiology Pipeline, with a focus on Immunology Clinical Trials. The individual will serve as a scientific resource for management and other functions, providing expertise in multiple scientific areas. Key responsibilities include developing and winning global business opportunities, providing scientific oversight of projects, coordinating study management, leading the development and peer-review of essential study documents, facilitating scientific advisory boards, and maintaining a strong understanding of clinical and epidemiological practice guidelines. The Director will also be responsible for building organizational capacity, improving scientific and operational processes, developing business opportunities in post-marketing safety and risk management, fostering relationships with sponsors and thought-leaders, and promoting company services through publications.

Requirements

• SME in Immunology Clinical Trials
• Requires graduate degree in Epidemiology, Statistics, or Public Health
• Requires in-depth knowledge of and experience with a variety of study designs
• 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

Nice To Haves

• Doctorate degree
• Familiarity with post-marketing and late phase study designs as well as relevant guidelines

Responsibilities

• 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.

Benefits

• 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
• flexible paid time off (PTO) and sick time

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees