Education Requirement: Doctor of Pharmacy (PharmD)
Work Arrangement: Onsite
Employment Type: Contract on W2
Job Description
Department/Team Overview
The Early Clinical Development organization is responsible for developing and executing early-stage clinical development strategies to evaluate the safety, efficacy, and utility of biomarkers for new molecular entities. The Clinical Scientist will contribute to clinical development strategies for assigned molecules and indications while supporting the planning and execution of Clinical Development Plans (CDPs).
This role offers an opportunity to gain experience in Phase I and Phase II drug development, clinical trial execution, medical data review, and cross-functional collaboration within a pharmaceutical research environment.
Key Responsibilities
- Participate in Clinical Science Sub-Teams (CSTs) and other relevant cross-functional teams to support clinical development activities.
- Prepare and present materials related to clinical study protocols, study execution, and interpretation of clinical development plans.
- Support or lead the development of clinical 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.
- Review, assess, and track protocol deviations on a regular basis.
- Draft protocol clarifications and amendments, ensuring associated ICFs and study documents are updated as required.
- Serve as an initial point of contact for protocol-related questions and study inquiries from internal stakeholders and external clinical sites.
- Support the preparation of clinical sections of regulatory documents and responses to health authority or ethics committee inquiries, under appropriate guidance.
- Collaborate with Safety Science teams to identify and track potential safety events during clinical studies.
- Contribute to strategic initiatives related to assigned molecules, clinical development plans, therapeutic areas, and portfolio priorities.
- Work collaboratively with cross-functional teams to ensure clinical deliverables are completed accurately and on schedule.
Required Qualifications
- Doctor of Pharmacy (PharmD) degree from an accredited School of Pharmacy.
- Must be legally authorized to work in the United States.
- Strong attention to detail and commitment to scientific integrity and ethical standards.
- Excellent written and verbal communication skills.
- Strong organizational and project management skills, with the ability to prioritize multiple assignments and meet deadlines.
- Strong interpersonal and collaboration skills, including the ability to influence stakeholders without direct authority.
- Ability to work effectively in complex, cross-functional team environments.
- Strong presentation skills, with the ability to summarize scientific information and communicate key considerations and decisions.
- Demonstrated teamwork skills and the ability to drive discussions toward actionable outcomes.
- Strong interest in learning early-stage clinical drug development, particularly Phase I and Phase II clinical trials.
Preferred Qualifications
- Prior pharmaceutical or biotechnology industry experience, including internships or part-time employment.
- Experience through Introductory Pharmacy Practice Experiences (IPPEs), Advanced Pharmacy Practice Experiences (APPEs), or other relevant clinical or pharmaceutical placements.
- Familiarity with clinical research, clinical trial protocols, informed consent documentation, medical data review, or drug development processes.
- Experience working in a complex, cross-functional, or matrixed organizational environment.
Physical Requirements
- Ability to perform repetitive hand and finger movements while using a computer, keyboard, mouse, and office equipment.
- Ability to read computer screens and review documents at close distances.
- Ability to remain seated for extended periods during office work and meetings.
- Ability to stand and walk occasionally within the office environment.
- Ability to communicate verbally and hear effectively during meetings and discussions.
Work Location Requirement
This position requires an onsite presence at the South San Francisco, California campus.