Senior Clinical Scientist

This is a fully remote position, open to applicants in North Carolina, +2 more states.

📋 Description

• Provide strategic direction and demonstrate accountability for clinical programs that support early clinical development and clinical pharmacology.

• Stay updated on the competitive landscape, current assets, and changing standards of care.

• Offer subject matter expertise on cross-functional project teams.

• Author, review, and approve clinical protocols, analysis plans, study reports, and regulatory submissions.

• Execute clinical and clinical pharmacology studies in collaboration with Clinical Operations.

• Review and summarize clinical safety and efficacy data alongside the Medical Monitor.

• Collaborate with Quantitative Clinical Pharmacology, Translational Sciences, and Statistics to develop protocols and summarize findings.

• Contribute to program strategy for assigned compounds and initiatives, including clinical development plans.

• Draft and review INDs, IND amendments, Investigator Brochures, Annual Reports, and other submissions to Health Authorities.

• Ensure adherence to timelines, budgets, scientific standards, regulatory requirements, and SOPs.

• Build collaborative relationships with consultants and external experts.

• Engage in project teams and liaise with project teams, CROs, Clinical sub-teams, and other stakeholders.

• Present data at both internal and external scientific meetings.

• Author manuscripts intended for scientific journals.

⛳️ Requirements

• A minimum of 5 years’ experience with a PhD, PharmD, or MD degree.

• Alternatively, a minimum of 10 years’ experience with a BS/MS degree in early development, clinical pharmacology, or a related field.

• Proven experience in early development, clinical pharmacology, or a related discipline.

• Strong ability to critically analyze problems and provide innovative solutions.

• Exceptional written and oral communication skills.

• Capability to present to and influence matrix teams and senior leaders.

• Ability to work independently and manage multiple priorities in a fast-paced environment.

• Experience in clinical pharmacology, immunology, or oncology is preferred.

• Early phase/Phase I experience is mandatory.

• Willingness to travel up to 20% of the time.

• Legal authorization to work in the country where the position is located.

• Ability to comply with departmental and organizational SOPs, scientific standards, and regulatory requirements.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.

• Accommodations available for individuals with disabilities.

• Reasonable accommodations provided during the recruitment process.

• Chance to contribute to a diverse, inclusive, and accessible workplace.

• Opportunity to positively impact patients’ lives.

• Commitment to sustainable business practices and community support.