Clinical Scientist

Required Degree: PharmD (Doctor of Pharmacy)

Job Description

Responsibilities

• Participate as a standing member of the Clinical Science Sub-Team (CST) and/or as an ad hoc member of relevant sub-teams. Prepare or present materials related to the development, execution, or interpretation of protocols and aspects of the Clinical Development Plan (CDP).
• Support or lead the development of study protocols, informed consent forms (ICFs), and clinical science study start-up documents.
• Conduct medical data reviews and collaborate with data management teams on data collection, review, and analysis strategies.
• Process and regularly review and analyze protocol deviations.
• Draft protocol clarifications and amendments as needed, ensuring that associated ICFs and study-related documents are completed and updated appropriately.
• Serve as an initial point of contact for protocol-related and study inquiries from internal colleagues and external clinical sites, addressing or triaging queries as appropriate.
• Support the preparation of clinical sections of regulatory documents and responses to health authority (HA) or ethics committee inquiries, in collaboration with Clinical Science and relevant team members.
• Collaborate with Safety Science to identify and track potential safety events within a study.
• Support strategic initiatives related to assigned molecules, the Clinical Development Plan (CDP), therapeutic areas, or the broader portfolio, as requested.

Qualifications

• Graduate with a Doctor of Pharmacy (PharmD) degree from an accredited School of Pharmacy.
• Eligible to work in the United States.
• Prior pharmaceutical or biotechnology industry experience or internships are encouraged but not required.
• Previous pharmaceutical industry experience, including Introductory Pharmacy Practice Experiences (IPPE), Advanced Pharmacy Practice Experiences (APPE), internships, or part-time employment, is preferred.
• Experience working in complex, matrixed environments.
• Demonstrates impeccable ethics and the ability to uphold organizational values, including scientific excellence, collaboration and inclusion, integrity, and ethical conduct.
• Outstanding attention to detail.
• Excellent project management skills, including the ability to prioritize multiple tasks, manage competing goals, and deliver high-quality work on time and within budget guidance.
• Strong interpersonal, verbal communication, and influencing skills, with the ability to build relationships with internal and external stakeholders and influence without formal authority.
• Outstanding written communication skills.
• Strong presentation skills, including the ability to summarize key considerations and decision points effectively.
• Excellent teamwork skills, with the ability to collaborate effectively, facilitate discussions, and drive decisions toward desired outcomes.
• A strong passion for learning about Phase I-II drug development.

Physical Requirements

• Repetitive hand and finger motions: Ability to use a computer keyboard, mouse, and other office equipment.
• Near vision: Ability to see clearly at close distances of 20 inches or less for reading computer screens and analyzing data.
• Sitting for extended periods: Ability to remain seated for most of the workday at a workstation or during meetings.
• Occasional standing and walking: Ability to move around the office and access printers, file cabinets, and other equipment.
• Verbal communication: Ability to speak and hear at normal levels to exchange information with colleagues and customers.

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