Clinical Development Scientist, Senior Manager
Pfizer
Summary
Responsible for the scientific and clinical oversight of clinical trials in support of the development strategy for programs within the Inflammation & Immunology (I&I) portfolio. As an individual contributor, this role focuses on ensuring data integrity and quality for clinical trials across both early and late-stage development, based on portfolio and resourcing needs. The Senior Manager partners with other clinical and medical colleagues, clinical operations, and other functional lines for the successful implementation and execution of the clinical trial(s) within the assigned program. This role is central to ensuring studies are conducted with the highest scientific and ethical standards. The role is also expected to leverage AI tools and other innovative technologies to improve ways of working, enhance efficiency, reduce work redundancy and improve quality.
Job description
Job Responsibilities
- Maintains current scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment.
- Authors and reviews key clinical and regulatory documents including, but not limited to, protocols, study-level informed consent forms (ICFs), Investigator's Brochures (IBs), clinical study reports (CSRs), and regulatory submission components.
- Leads the clinical data review strategy, including the ongoing review of emerging clinical data for safety and efficacy trends.
- Presents relevant data to internal teams, governance bodies, and other stakeholders.
- Collaborates with cross-functional team members (e.g., Clinical Operations, Biostatistics, Regulatory Affairs, Clinical Pharmacology) to ensure trial objectives are met and activities are executed seamlessly.
- Provides scientific and clinical input for site training materials and supports responses to questions from investigators and site personnel regarding the protocol and study conduct.
- Ensures compliance with relevant SOPs, regulations, and Good Clinical Practice (GCP); seeks opportunities to improve quality and efficiency of clinical development procedures and may participate in process improvement workgroups.
- Contributes to the preparation for Health Authority meetings and may participate as appropriate.
- May mentor junior team members.
Qualifications / Skills
- Advanced degree (PhD, PharmD, MS) in a relevant scientific discipline is required. This is a non-MD role.
- Experience requirements: PhD/PharmD with 2+ years of relevant experience in clinical research. or MS with 5+ years of relevant experience in clinical research.
- Demonstrated experience in clinical development within the pharmaceutical/biotechnology industry is required.
- Experience in the Inflammation & Immunology (I&I) therapeutic area is preferred but not required.
- Strong understanding of the drug development process, clinical trial design, and execution.
- Excellent knowledge of clinical procedures, ICH guidelines, and Good Clinical Practice (GCP).
- Proven scientific writing skills and strong verbal communication skills.
- Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate.
- Strong analytical, organizational, and project management skills with the ability to manage multiple projects and priorities.
Work Location Assignment: This is a Hybrid that requires candidates to commute on time an average of two days a week.
Requirements
- Advanced degree (PhD, PharmD, MS) in a relevant scientific discipline is required. This is a non-MD role.
- PhD/PharmD with 2+ years of relevant experience in clinical research, or MS with 5+ years of relevant experience in clinical research.
- Demonstrated experience in clinical development within the pharmaceutical/biotechnology industry is required.
- Strong understanding of the drug development process, clinical trial design, and execution.
- Excellent knowledge of clinical procedures, ICH guidelines, and Good Clinical Practice (GCP).
- Proven scientific writing skills and strong verbal communication skills.
- Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate.
- Strong analytical, organizational, and project management skills with the ability to manage multiple projects and priorities.
Benefits
- 401(k) Matching
- Retirement Savings Contribution
- Paid Vacation
- Holiday & Personal Days
- Paid Caregiver/Parental Leave
- Medical Leave
- Medical, Dental & Vision
- Prescription Drug Coverage
- Share Based Long Term Incentive
- Bonus
Company overview
Pfizer Inc. is an American multinational pharmaceutical and biotechnology corporation headquartered in New York City, founded in 1849 by German entrepreneurs Charles Pfizer and Charles F. Erhart. As one of the world's largest pharmaceutical companies, Pfizer develops and produces medications and vaccines across multiple therapeutic areas including immunology, oncology, cardiology, endocrinology, and neurology. The company is renowned for breakthrough drugs such as Lipitor, Viagra, and more recently, the Pfizer-BioNTech COVID-19 vaccine. With approximately 81,000 employees globally and operations in about 200 countries, Pfizer maintains 37 manufacturing sites worldwide. The company's current strategic focus includes oncology, rare diseases, and innovative vaccine development, while implementing significant cost-saving initiatives. Pfizer continues to advance its research pipeline with over 100 projects and maintains a strong commitment to scientific innovation and global healthcare access.