Principal Research Scientist ONC -Clinical Development Scientist (Sponsor Dedicated/ Remote US)

JOB SUMMARY

The Principal research scientist is responsible for coordinating and carrying out the full spectrum of activities related to the development and validation of bioanalytical methods according to client requests and within the required timeframes.

• Develops a solid understanding of clinical trial design and applies this knowledge to support the creation of study concept documents and clinical protocols.
• Participates in protocol review meetings, contributing to discussions on scientific rationale and operational study design considerations.
• Assists in the preparation of study protocols, protocol amendments, investigator meeting materials, study manuals, and other clinical trial documentation under appropriate guidance.
• Contributes to the development of Case Report Forms (CRFs), Data Management Plans, and Statistical Analysis Plans with supervision.
• Supports responses to investigator inquiries related to scientific, clinical, and procedural aspects of studies.
• Assists in the preparation and review of data outputs, summary reports, study findings, manuscripts, and scientific presentations.
• Provides support in the development and review of regulatory submission documents.
• Identifies and helps address moderately complex study-related challenges, implementing solutions with guidance from experienced team members.
• May coordinate project teams and provide direction on assigned activities when required.
• May perform clinical monitoring responsibilities for individual studies or specific components of larger clinical programs.
• Demonstrates the ability to quickly learn new therapeutic areas and synthesize relevant scientific literature to support study development activities.
• Ensures compliance with applicable regulatory requirements, Good Clinical Practice (GCP) guidelines, and company Standard Operating Procedures (SOPs).

• PharmD or PhD with 3+ years in clinical research or clinical pharmacology with scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment.
• MS with 6+ years’ relevant scientific and/or drug development experience.
• BS or RN with 8+ years’ relevant scientific and/or drug development experience.
• Relevant experience in Multiple Myeloma and/or CAR-T Therapy is preferred.
• Experienced with Microsoft Office and other job-related programs.
• Must demonstrate good computer skills especially in the utilization of Microsoft Word and Excel and analytical software (E.g. Analyst).
• Demonstrates skills in scientific problem solving.
• English level: Required bilingualism includes communicating verbally and in writing on topics that are often technical, and writing procedures or technical reports.

At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a 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, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

$79,800.00 - $139,600.00

The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.

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