What are the responsibilities and job description for the Senior Manager Genetic Clinical Scientist position at Regeneron Pharmaceuticals?
Job Title:
Sr. Manager of Genetic Clinical Sciences
Description:
This role leads the development and clinical experimentation for projects from discovery phase through Phase 3 in a matrix environment.
Daily Responsibilities:
- Facilitates/Leads the writing of Clinical Study Concepts (CSCs) and Clinical Study Protocols (CSPs) and amendments.
- Identifies key internal and external collaborators/advisors, organizes and conducts consultations with global subject matter experts.
- Represents the clinical genetic medicine function on clinical study teams, contributing medical/scientific knowledge to timely and compliant clinical trial execution and quality of deliverables.
- Works alongside Clinical Trial Manager to provide day-to-day clinical input to the study team.
- Drafts and reviews clinical sections in regulatory and clinical documents such as: Regulatory agency briefing books, IND/IMPD submissions, investigator's brochure, informed consent forms, IRB/IEC submissions, clinical study reports, abstracts/manuscripts for publication, etc.
- Reviews study related documents such as: medical monitoring plans, statistical analysis plans, data management plan, eCRF completion guidelines, data validation manuals, database UAT, etc
- Trains and supports study team and CRO personnel regarding clinical aspects of trial.
Requirements:
- Demonstrated ability to influence within team and may influence across functionally; Strong management, interpersonal and problem-solving skills
- Exhibits strong analytical and influencing skills; ability to communicate concise and clear messages, strong presentation skills
- Independently uses professional concepts and company objectives to resolve complex issues in creative and effective ways
Education and Experience:
- Bachelor's Degree; Advanced degree or equivalent education/degree in life science/healthcare preferred (PhD/MD/PharmD/MSc)
- 6 or more years of pharmaceutical clinical drug development experience
- Proven knowledge of the drug development process, Good Clinical Practice, study design, clinical research methodology & medical writing skills
- Knowledge of clinical development process, regulatory requirements and ICH/GCP guidelines
- Proven track record in clinical trial process improvements
- Prior experience with organizational awareness, including significant experience working cross-functionally
Work Environment:
This is not a remote role and requires 3 days in the office each week.
Company Culture:
We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.
Equal Opportunity Employer:
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.
