Scientist Jobs

About The Position

Requirements

• MS, PhD, or PharmD in a related field.
• 8 or more years of pharmaceutical clinical drug development experience; other levels may be considered depending on experience.
• Knowledge of the drug development process, GCP, ICH guidelines, study design, and clinical research methodology.
• Strong medical writing, analytical, and presentation skills, with the ability to communicate clear and concise messages.
• Ability to influence within a team and cross-functionally in a matrix environment.
• Strong problem-solving and interpersonal skills, with the ability to resolve complex issues creatively and independently.

Nice To Haves

• Experience in cardiovascular, renal, or metabolic disease.
• A track record of clinical trial process improvements.

Responsibilities

• Partner with Medical Directors to provide scientific expertise for designing and conducting clinical studies.
• Contribute to clinical study teams, program team meetings, advisory boards, steering committees, and data and safety monitoring meetings.
• Support early- and/or late-phase studies by developing protocol synopses and authoring or reviewing protocols and amendments.
• Author and review study documents, including medical monitoring plans, statistical analysis plans, informed consents, and clinical study report sections.
• Perform clinical and medical data review, including safety monitoring, to protect patient safety.
• Work with internal functions and external vendors to promote study integrity and consistent data review practices.
• Identify critical risks and recommend mitigations by analyzing the effects of study objectives and design on data analysis.
• Build and maintain knowledge of the disease area, mechanism of action, and drug landscape while upholding FDA, EMA, ICH, and GCP standards.

Benefits

• Competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, medical, dental, vision, life and disability insurance, paid time off, and family support benefits.