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

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

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
 
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
 
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 deliver – for one another, our customers, and, most importantly, for those in need.
 
Discover what your 25,000 future colleagues already know:
 
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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. 

Job Responsibilities

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.

JOB RESPONSIBILITIES

• 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).

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QUALIFICATION REQUIREMENTS

• 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.

Salary Range:

$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.

Get to know Syneos Health

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

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.