Role Summary
The Senior Manager, Internal Medicine, Clinical Scientist leads the development, evaluation, planning, and execution of clinical studies and ensures integrity and interpretation of study data within a clinical development program. Leads in a matrix, cross-functional environment and collaborates with Medical Director(s) (MDs) to design and deliver clinical studies and programs.
Responsibilities (typical day)
- Contribute to program team meetings, scientific advisory boards, study steering committees, and data/safety monitoring meetings; participate in cross-department collaboration as a member of the Clinical Study Team and Global Clinical SubTeam.
- Develop/maintain knowledge of therapeutic disease area(s), drug candidate (disease biology, clinical manifestations, standard practice), and drug landscape/mechanism of action.
- Support initiation and execution of early and/or late-stage clinical research and development studies; assist with Expanded Synopsis; author and/or review protocol and amendments.
- Assist with and may author/review medical monitoring plans, Statistical Analysis Plans (SAPs), informed consents, and Clinical Study Report clinical components; support regulatory document development; perform quality review.
- Maintain compliance with FDA/EMEA/ICH/GCP and applicable SOPs for clinical safety.
- Perform clinical/medical data review, including safety monitoring to ensure patient safety.
- Collaborate with internal functions and external vendors to promote study integrity.
- Apply analytical skills to connect study objectives/design to data analysis; identify critical risks and mitigations; promote consistent medical/clinical data review techniques.
Qualifications
- BS/MS/PhD/PharmD in a related field.
- β₯ 8 years of pharmaceutical clinical drug development experience.
- Experience in Immune/Inflammatory related clinical trials (one or more therapeutic areas).
Skills/Requirements
- Ability to influence within and across functions; strong analytical, influencing, communication, and presentation skills.
- Strong management, interpersonal, and problem-solving skills.
- Proven knowledge of drug development process, GCP, study design, clinical research methodology, and medical writing; knowledge of regulatory requirements and ICH/GCP; track record of clinical trial process improvements.