Contract - Clinical Scientist

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Requirements:

• Advanced degree (MD, PhD, PharmD; MS with additional direct experience) in a life sciences or health-related field strongly preferred.
• 3+ years of experience in clinical research, preferably within the biopharmaceutical or biotechnology industry.
• Strong understanding of biostatistics and experience in interpreting clinical data.
• Proficiency in medical writing and developing high-quality scientific documents.
• Familiarity with Good Publication Practices (GPP) and experience in ensuring compliance with GPP guidelines in scientific writing and publication.
• Experience with data visualization tools (e.g., GraphPad Prism, Tableau, R) and presentation software (e.g., PowerPoint).
• Proven ability to create and generate scientific presentations for consumption by a diverse audience.
• Familiarity with clinical trial design, execution, and regulatory requirements (e.g., FDA, EMA).
• Excellent organizational, interpersonal, and communication skills.
• Ability to work collaboratively in a multidisciplinary team environment.
• Strong attention to detail and ability to manage multiple tasks simultaneously.

Responsibilities:

• Collaborate with medical leads in the planning of early and late-phase clinical research studies.
• Work closely with clinical pharmacology and drug safety teams to integrate pharmacokinetic and safety data into overall clinical study designs.
• Provide outputs that may be incorporated into documents such as investigator brochures, clinical study reports, and other regulatory documents.
• Conduct data reviews of clinical data sets and participate in statistical analyses in collaboration with biostatisticians.
• Develop data visualization strategies to effectively communicate clinical trial data and outcomes.
• Prepare scientific presentations for internal and external audiences, including scientific conferences, advisory boards, and regulatory meetings.
• Contribute to the preparation and submission of manuscripts for publication in peer-reviewed journals, ensuring adherence to Good Publication Practices (GPP).
• Support the development of clinical study documents, including study protocols, and patient-facing materials.
• Maintain up-to-date knowledge of relevant scientific literature, therapeutic area trends, and regulatory requirements impacting clinical trials and drug development.