Principal Research Scientist – Clinical Development

This is a fully remote position, open to applicants in United States.

📋 Description

• Accountable for coordinating and executing the complete range of activities associated with the development and validation of bioanalytical methods based on client requirements and within stipulated timelines.

• Develops a comprehensive understanding of clinical trial design and utilizes this expertise to assist in crafting study concept documents and clinical protocols.

• Engages in protocol review meetings, contributing insights on scientific rationale and operational study design considerations.

• Aids in the preparation of study protocols, protocol amendments, investigator meeting materials, study manuals, and other clinical trial documentation under proper supervision.

• Contributes to the formulation of Case Report Forms (CRFs), Data Management Plans, and Statistical Analysis Plans with oversight.

• Provides support for responses to investigator inquiries regarding scientific, clinical, and procedural aspects of studies.

• Assists in the compilation and review of data outputs, summary reports, study findings, manuscripts, and scientific presentations.

• Offers assistance in the development and review of regulatory submission documents.

• Identifies and helps resolve moderately complex study-related issues, implementing solutions with guidance from experienced team members.

• May coordinate project teams and guide assigned activities when necessary.

• May undertake clinical monitoring duties for individual studies or specific components of larger clinical programs.

• Exhibits the ability to rapidly absorb new therapeutic areas and synthesize relevant scientific literature to support study development initiatives.

• Ensures adherence to applicable regulatory standards, Good Clinical Practice (GCP) guidelines, and company Standard Operating Procedures (SOPs).

⛳️ Requirements

• PharmD or PhD with more than 3 years of experience in clinical research or clinical pharmacology, including scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia, or a related environment.

• MS degree with over 6 years of relevant scientific and/or drug development experience.

• BS degree or RN with more than 8 years of relevant scientific and/or drug development experience.

• Preferred experience in Multiple Myeloma and/or CAR-T Therapy.

• Proficient in Microsoft Office and other job-related software applications.

• Must exhibit strong computer skills, particularly in the use of Microsoft Word and Excel, as well as analytical software (e.g., Analyst).

• Demonstrates competencies in scientific problem-solving.

• English proficiency: Required bilingualism includes the ability to communicate verbally and in writing on often technical topics, as well as writing procedures or technical reports.

🏝️ Benefits

• Health benefits including Medical, Dental, and Vision coverage.

• Company-matched 401k plan.

• Eligibility to join the Employee Stock Purchase Plan.

• Opportunity to earn commissions/bonuses based on both company and individual performance.

• Flexible paid time off (PTO) and sick leave.