Senior Clinical Research Director
1 dia atrás
This senior leadership position is responsible for the development and execution of clinical research strategies and independent direction of Phase 1-3 clinical studies.
- Develops study protocols in conjunction with a multidisciplinary Development Team.
- Assists in the identification and selection of clinical investigators for trials and maintains professional Sponsor medical monitor/representative relationships.
- Conducts medical assessments and dispositions of adverse events, evaluates safety of clinical compounds before and during studies.
- Oversees the clinical trials program with Clinical Operations according to NBI SOPs, Good Clinical Practice, and applicable regulations.
- Analyzes, interprets, and presents results of clinical studies to internal and external audiences as directed by Sr. Management.
- Identifies resource requirements, assists in budget planning and personnel forecasting for clinical research programs.
- Assists in recruitment, training, and development of clinical teams.
- Identifies and selects clinical consultants.
- Provides or assists in scientific writing and review of clinical study reports and regulatory documents.
- Provides periodic status updates and communicates with Senior Management Team.
- Leads the development of clinical biomarker strategies for early clinical development.
- Works with Medical Affairs and external opinion leaders to secure new collaborators and present trial results.
- Interfaces with Research, Product Development, and Business Development to assess new product opportunities and develop clinical research strategy and product development plans.
Requirements:
- MD or DO with accredited residency training and board certification in a relevant clinical specialty for the therapeutic area; 2+ years of experience in clinical research and development (Phase 1-4) in pharma/biotech or clinical research/academic setting.
- Knowledge of Good Clinical Practice and regulatory procedures relevant to investigational drug development.
- Strong knowledge in translational medicine, biomarker evaluation, clinical study execution, regulatory documents, study design, biostatistics, data analysis, report writing, and data presentation.
- Ability to operate effectively in a multi-level matrix environment and interact with physicians, scientists, monitors, regulatory, commercial, and consultant personnel.
- Demonstrated success managing interactions with external CROs and consultants, especially in a small group.
- Proven track record across all phases of drug development and in clinical trial design.
- Recognized as an internal thought leader with extensive technical and business expertise.
- Strong problem-solving and innovative capabilities within a strategic organization.
- Evaluates key business and scientific challenges and leads cross-functional initiatives.
- Strong interpersonal, organizational, and leadership skills.
- Ability to work independently and prioritize multiple tasks to meet timelines and budget targets.
Benefits:
- Retirement plan with company match.
- Paid vacation, holidays, personal days, caregiver/parental and medical leave.
- Health benefits (medical, prescription, dental, vision).
Other Opportunities:
- Opportunities for career growth and professional development.
- Collaborative and dynamic work environment.
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