Role Description
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
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Develops a solid understanding of clinical trial design and applies this knowledge to support the creation of study concept documents and clinical protocols.
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Participates in protocol review meetings, contributing to discussions on scientific rationale and operational study design considerations.
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Assists in the preparation of study protocols, protocol amendments, investigator meeting materials, study manuals, and other clinical trial documentation under appropriate guidance.
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Contributes to the development of Case Report Forms (CRFs), Data Management Plans, and Statistical Analysis Plans with supervision.
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Supports responses to investigator inquiries related to scientific, clinical, and procedural aspects of studies.
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Assists in the preparation and review of data outputs, summary reports, study findings, manuscripts, and scientific presentations.
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Provides support in the development and review of regulatory submission documents.
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Identifies and helps address moderately complex study-related challenges, implementing solutions with guidance from experienced team members.
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May coordinate project teams and provide direction on assigned activities when required.
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May perform clinical monitoring responsibilities for individual studies or specific components of larger clinical programs.
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Demonstrates the ability to quickly learn new therapeutic areas and synthesize relevant scientific literature to support study development activities.
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Ensures compliance with applicable regulatory requirements, Good Clinical Practice (GCP) guidelines, and company Standard Operating Procedures (SOPs).
Qualifications
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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.
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MS with 6+ years' relevant scientific and/or drug development experience.
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BS or RN with 8+ years' relevant scientific and/or drug development experience.
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Relevant experience in Multiple Myeloma and/or CAR-T Therapy is preferred.
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Experienced with Microsoft Office and other job-related programs.
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Must demonstrate good computer skills especially in the utilization of Microsoft Word and Excel and analytical software (E.g. Analyst).
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Demonstrates skills in scientific problem solving.
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English level: Required bilingualism includes communicating verbally and in writing on topics that are often technical, and writing procedures or technical reports.
Benefits
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Company car or car allowance.
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Health benefits to include Medical, Dental and Vision.
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Company match 401k.
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Eligibility to participate in Employee Stock Purchase Plan.
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Eligibility to earn commissions/bonus based on company and individual performance.
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Flexible paid time off (PTO) and sick time.
Company Description
Syneos Healthยฎ 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.
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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.
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We are committed to building an inclusive culture - where you can authentically be yourself.
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We are continuously building the company we all want to work for and our customers want to work with.