Dir, Epidemiology Pipeline (TA-Oncology)

Syneos Health • York, WA

1d

About The Position

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. This position, Dir, Epidemiology Pipeline (TA-Oncology), is part of an ongoing talent pipeline, meaning there is no immediate opening, but qualified candidates will be considered as opportunities become available. The role is for a Subject Matter Expert (SME) in Oncology Clinical Trials. The Director serves as a scientific resource for RWLP management, Company senior management, and other Functions within the Company, providing expertise in multiple scientific areas. Key aspects of the role include collaborating with RWLP management, business development, and operations to develop and secure global business opportunities, leading the development and delivery of project proposals, bid defenses, and capabilities presentations. The Director is responsible for the overall scientific oversight of selected projects, ensuring customer expectations for timelines, budgets, quality, and satisfaction are met or exceeded. This involves coordinating with project managers on scientific aspects of study start-up and ongoing management, and leading or peer-reviewing essential study documents such as protocols, case report forms, statistical analysis plans, study management plans, and interim/final study reports. The role also entails facilitating scientific advisory boards for safety studies and producing scientific reports, manuscripts, abstracts, and presentations. Furthermore, the Director is expected to maintain a strong understanding of clinical and epidemiological practice guidelines, clinical research models, protocol designs, real-world research development trends, and regulatory expectations, and to develop training for the organization. Responsibilities also cover building organizational capacity, improving scientific and operational processes for non-traditional site management (e.g., remote monitoring), integrated RWLP technology solutions, and SOP development. The Director will work collaboratively to develop business opportunities in post-marketing safety commitments and risk management, recommending techniques to improve productivity and efficiency. Developing collegial relationships with sponsors, thought-leaders, and clinical investigators, and promoting Company services through publications are also key aspects. Syneos Health emphasizes developing its people, fostering a 'Total Self' culture, and building a diverse and inclusive workplace where employees can thrive and advance.

Requirements

• SME in Oncology 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 preferred
• Familiarity with post-marketing and late phase study designs as well as relevant guidelines preferred

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

• Career Level: Director
• Number of Employees: 5,001-10,000 employees