Sr. Scientist, Clinical Development Contractor (Part-Time)

Position Summary:

We are seeking a dynamic and highly motivated Scientist/Senior Scientist, Clinical Development to be an essential contributor to the scientific, clinical, and operational scope of the clinical development program with an emphasis on program-specific activities. This position in Clinical Development is responsible for providing scientific input during protocol development/amendments, oversight of clinical aspects of study conduct, and interpretation of study results through the final study report. This role will work on cross-functional program development and study management teams for the design, execution, and monitoring of clinical trials, as well as assist with data interpretation and communication to both internal and external stakeholders. The successful candidate will be highly collaborative and motivated, with excellent knowledge of late-phase clinical trials, preferably with experience in kidney disease or cardio-renal-metabolic syndrome, and/or cell therapy. The candidate must also possess excellent communication, and organizational skills, be solution-oriented, exhibit high attention to detail and quality, and have strong initiative and execution to timelines.

*This is a contract position and will not be eligible for ProKidney benefits*

This position is expected to work 20-30 hours/week.

Responsibilities:

• Co-leads the cross-functional study team to execute on the clinical development strategy
• Protocol and ICF development processes with minimal guidance; including writing, reviewing, resolution of cross functional comments and ensuring high clinical quality.
• Woks in partnership with Clinical Operations and collaborates with cross-functional study team members (e.g., Regulatory Affairs, Safety, Data Management).
• Maintain a thorough understanding of assigned protocols and protocol requirements
• Supports the coordination of relevant and timely data analyses and presentations in collaboration with safety, data management, biometrics, and other relevant teams to meet timelines
• Act as recognized scientific expert for assigned programs.
• Draft/review and validation of clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, regulatory responses)
• Support safety evaluations and processes related to the program.
• Support labelling, distribution, and operational activities for clinical study, as needed.

Qualifications:

• MD and/or PhD from an accredited institution with proven clinical/academic Board eligibility or certification in medical subspecialty preferred.
• At least 5 years of clinical development experience at a pharmaceutical, CRO or biotechnology company with experience in nephrology, cardio-metabolism or cell therapy Late-stage drug development experience preferred. BLA experience is a plus.
• Excellent knowledge of current Good Clinical Practices (GCP), research ethics and guidance in the pharmaceutical Proficient knowledge of drug development process, study design, statistics, clinical operations.
• Reasonable experience with clinical evaluation projects including development of protocols, case report forms, informed consent and study initiation and monitoring preferred.
• Excellent written communication, oral communication, and presentation skills are required.
• Ability to handle multiple projects at a time and have a strong attention to detail while understanding the higher-level strategy.
• Proficient knowledge and skills to support program specific data review, trend identification, data interpretation.
• Ability to share scientific data effectively across functions and through presentations.
• Demonstrated ability to think analytically and strategically, work independently and solve problems.
• Skilled at prioritizing tasks to deliver on deadlines in a highly collaborative and collegial work style.

ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.