Director – Clinical Pharmacologist / Clinical Research Scientist

This is a fully remote position, open to applicants in United States.

📋 Description

• Advance several early-stage clinical assets into first-in-human trials or assist in their further development through clinical pharmacology and mechanistic studies.

• Create, execute, and report on global clinical trials for new compounds.

• Execute global clinical trials and document adverse events in compliance with corporate patient safety standards.

• Evaluate protocols, study reports, publications, data dissemination, labels, grant submissions, contracts, and regulatory materials.

• Design clinical strategies and development programs for regulatory submissions.

• Assist with first-in-human dosing studies and biomarker strategies.

• Collaborate with Global Patient Safety, PK/PD, ADME, Statistics, and Tailored Therapeutics teams.

• Work alongside discovery research scientists on research strategies, candidate selection, and pre-clinical development.

• Design and supervise clinical pharmacology studies, biomarker qualification studies, and protocol development.

• Support study documentation and collaborate with clinical research personnel, statisticians, health outcomes scientists, consultants, and investigators.

• Engage in investigator identification and selection, study initiation meetings, and investigator/site training.

• Manage ethical reviews, informed consent processes, regulatory approvals, and study initiation requirements.

• Act as a resource for clinical trial managers, monitors, investigators, and ethical review boards.

• Oversee patient safety and implement pharmacovigilance measures.

• Manage partnerships with Third Party Organizations for study execution.

• Respond to scientific inquiries from external healthcare professionals.

• Participate in clinical trial registry activities, publication strategies, data analysis, and final reporting.

• Present clinical trial findings to corporate committees, regulatory bodies, and external organizations.

• Prepare clinical reports and regulatory submissions, including medical sections of INDs and Investigator Brochures.

• Cultivate and maintain a scientifically excellent workforce while promoting inclusion, innovation, and continuous improvement.

• Support medical strategies for brand commercialization, business development, and strategic brand planning.

• Maintain relationships with external experts and opinion leaders, supporting business-to-business and government activities.

⛳️ Requirements

• An advanced health/medical/scientific graduate degree (e.g., Pharmacology, Physiology, Microbiology) or a related graduate degree (e.g., PharmD, PhD, MSN) with an advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner).

• A minimum of 3 years of experience in the pharmaceutical industry or a related field, particularly in clinical trial design and the conduct of Phase 1 or Phase 2 studies.

• At least 3 years of experience in clinical practice.

• Proficiency in English, with strong written and verbal communication skills.

• Excellent communication, interpersonal, organizational, teamwork, and negotiation capabilities.

• Ability to influence others within teams and across a matrix environment.

• Willingness to engage in domestic and international travel as necessary to support the team's objectives.

🏝️ Benefits

• Company bonus based on both company and individual performance.

• Company-sponsored 401(k) plan.

• Pension plan.

• Vacation benefits.

• Medical, dental, vision, and prescription drug coverage.

• Flexible benefits including healthcare and/or dependent daycare flexible spending accounts.

• Life insurance and death benefits.

• Certain time off and leave of absence benefits.

• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.