Lead Clinical Scientist – Oncology, Gynecologic Malignancies

This is a fully remote position, open to applicants in New York.

📋 Description

• Collaborate with the Medical Director to create Medical Management, Medical Data Review, and Eligibility Review Plans.

• Engage external experts, consultants, and advisors to gather medical and scientific insights.

• Conduct regular and ad-hoc medical reviews of data listings and visual representations.

• Analyze data to detect risks and trends, while documenting medical reviews.

• Draft medical data queries, evaluate responses, and secure query closure approval from the Medical Director.

• Assist in reviewing patient profiles, scientific study data, protocol deviations, and Medical Review Summary reports.

• Partner with Medical Directors for medical data and safety review meetings, including preparation of presentation slides.

• Oversee project scope, objectives, deliverable quality, milestones, and timelines.

• Act as the primary liaison among internal teams, clients, and vendors concerning medical data and eligibility reviews.

• Collaborate with Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management teams.

• Identify and escalate issues related to data integrity, subject safety, project deliverables, and scope.

• Attend and present at Trusted Process meetings, and take part in internal and external audits.

• Manage a limited number of direct reports and engage in or conduct interviews.

⛳️ Requirements

• Extensive experience and deep knowledge in clinical/medical science and drug development.

• Fundamental understanding of ongoing protocol designs.

• Basic knowledge of disease-related terminology and pathology.

• Familiarity with medical data review and eligibility review processes.

• Understanding of data listings and data visualization techniques.

• Knowledge of data integrity and identification of subject safety risks.

• Awareness of International Committee on Harmonization (ICH) guidelines.

• Knowledge of Good Clinical Practices (GCPs).

• Commitment to adhering to data privacy guidelines, enterprise policies, standard operating procedures, work instructions, and project plans.

• Equivalent experience, skills, and/or education will be taken into account.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management.

• Training in technical and therapeutic areas.

• Peer recognition and a comprehensive rewards program.

• Company-provided vehicle or car allowance.

• Medical, Dental, and Vision health benefits.

• Company matching 401k plan.

• Eligibility for the Employee Stock Purchase Plan.

• Opportunity to earn commissions or bonuses based on individual and company performance.

• Flexible paid time off (PTO).

• Sick leave benefits.