Senior Director Clinical Science - Remote Position
Puma Biotechnology, Inc.
20 days ago
Remote
United States
Clinical Research and Development
The Senior Director, Clinical Science (Non‑MD) is a senior clinical science leader responsible for shaping and driving clinical development strategy and providing scientific oversight across one or more programs.
Major Duties / Responsibilities
- Clinical & Development Strategy Leadership: Advise on and drive clinical development strategy across one or multiple projects/programs; provide scientific leadership by reviewing, interpreting, and synthesizing clinical (and when applicable, preclinical) data and literature; oversee clinical management and scientific support across drug products/programs (portfolio scope).
- Data Review, Interpretation & Scientific Communication: Review, interpret, and present data internally and externally (regulatory meetings, congresses, advisory committees); communicate Clinical Science perspectives to senior management.
- Regulatory & Scientific Documentation: Lead authoring/critical review of Clinical Study Reports, Clinical Study Protocols, and clinical components of regulatory submissions (e.g., NDA/MAA and other submissions); develop and write key regulatory documents (e.g., IND, NDA/sNDA, Investigator’s Brochure) ensuring accuracy/completeness.
- External Scientific Leadership: Represent programs at conferences/advisory committees; lead interactions with investigators and cooperative groups.
- Functional Leadership & People Management: Oversee Clinical Science team(s) for quality/consistency; hire, develop, mentor, and performance-manage staff; act as senior clinical science escalation point.
Skills, Abilities & Competencies
- Relationship building and collaborative leadership of high-performing teams.
- Strong understanding of preclinical/clinical development, trial execution, post-approval considerations, and regulatory expectations.
- Expertise in clinical development planning, protocol design/writing, study leadership, data review/interpretation, and CSR delivery.
- Strong written/oral/presentation skills.
- Cross-functional people/project management in matrix environments.
- Deep knowledge of ICH/FDA/EMA.
Qualifications
- Advanced Clinical/Science degree (e.g., PhD, PharmD) preferred; or 15–20+ years directly relevant clinical research/development experience.
- Strong working knowledge of global regulatory requirements and a sustained record of high-quality clinical science deliverables and leadership.
Compensation/Benefits
- Salary range: $275,000–$325,000 per year; annual bonus target and robust benefits package.
Other
- Full-time; remote/virtual; travel up to ~10% as needed.
Major Duties / Responsibilities
- Clinical & Development Strategy Leadership: Advise on and drive clinical development strategy across one or multiple projects/programs; provide scientific leadership by reviewing, interpreting, and synthesizing clinical (and when applicable, preclinical) data and literature; oversee clinical management and scientific support across drug products/programs (portfolio scope).
- Data Review, Interpretation & Scientific Communication: Review, interpret, and present data internally and externally (regulatory meetings, congresses, advisory committees); communicate Clinical Science perspectives to senior management.
- Regulatory & Scientific Documentation: Lead authoring/critical review of Clinical Study Reports, Clinical Study Protocols, and clinical components of regulatory submissions (e.g., NDA/MAA and other submissions); develop and write key regulatory documents (e.g., IND, NDA/sNDA, Investigator’s Brochure) ensuring accuracy/completeness.
- External Scientific Leadership: Represent programs at conferences/advisory committees; lead interactions with investigators and cooperative groups.
- Functional Leadership & People Management: Oversee Clinical Science team(s) for quality/consistency; hire, develop, mentor, and performance-manage staff; act as senior clinical science escalation point.
Skills, Abilities & Competencies
- Relationship building and collaborative leadership of high-performing teams.
- Strong understanding of preclinical/clinical development, trial execution, post-approval considerations, and regulatory expectations.
- Expertise in clinical development planning, protocol design/writing, study leadership, data review/interpretation, and CSR delivery.
- Strong written/oral/presentation skills.
- Cross-functional people/project management in matrix environments.
- Deep knowledge of ICH/FDA/EMA.
Qualifications
- Advanced Clinical/Science degree (e.g., PhD, PharmD) preferred; or 15–20+ years directly relevant clinical research/development experience.
- Strong working knowledge of global regulatory requirements and a sustained record of high-quality clinical science deliverables and leadership.
Compensation/Benefits
- Salary range: $275,000–$325,000 per year; annual bonus target and robust benefits package.
Other
- Full-time; remote/virtual; travel up to ~10% as needed.