What are the responsibilities and job description for the Clinical Development Associate Director (W2 Role, 10+y exp) - Remote | WFH position at Get It - Executive?
Job Overview
Join a leading organization in the pharmaceutical and biotechnology sectors as an Associate Director of Clinical Development. In this critical role, you will leverage your extensive experience to lead research initiatives, analyze complex data sets, and contribute to groundbreaking drug development efforts that can profoundly impact patient outcomes.
Key Responsibilities
This role provides significant potential for professional advancement within the clinical research domain, offering pathways for leadership and mentorship, thereby facilitating personal and career development in a dynamic and impactful setting.
Employment Type: Full-Time
Join a leading organization in the pharmaceutical and biotechnology sectors as an Associate Director of Clinical Development. In this critical role, you will leverage your extensive experience to lead research initiatives, analyze complex data sets, and contribute to groundbreaking drug development efforts that can profoundly impact patient outcomes.
Key Responsibilities
- Address intricate challenges through comprehensive assessments of diverse data sources.
- Employ expert judgment to select appropriate methodologies, techniques, and evaluation criteria for optimal results.
- Act as an internal consultant, providing strategic insights to senior management on research, technology, and developmental initiatives.
- Spearhead the application of scientific and professional principles to align with corporate objectives innovatively and effectively.
- Integrate multiple data sources to uncover insightful and unexpected conclusions.
- Define complex challenges and formulate robust experimental strategies.
- Assist in the preparation of regulatory submissions while collaborating with various departments, stakeholders, and partners.
- Partner with the Commercial team to develop novel concepts and contribute to process enhancements.
- Organize and coordinate team activities, including the writing and reviewing of intricate reports and protocols.
- A minimum of 5 years of experience within a pharmaceutical, CRO, or biotech context.
- A strong foundation in immunology, particularly in areas such as Rheumatoid Arthritis, Atopic Dermatitis, Ulcerative Colitis, and Alopecia Areata.
- Proven expertise in clinical development, especially in Phase 2 or late-stage drug development.
- Proficient analytical skills, particularly in data analysis, interpretation, and comprehension of safety and pharmacovigilance principles.
- Experienced in reviewing clinical data, including data listings, patient profiles, drug class identification, and adverse event evaluations.
- Strong capability to assess, interpret, and communicate complex scientific data effectively to diverse audiences.
- Familiarity with FDA-regulated environments and knowledge of current Good Manufacturing Practices (GMPs).
- Proficient in Microsoft Word, Excel, and PowerPoint.
- Exemplary judgment, problem-solving skills, and organizational abilities.
- A PharmD or PhD in a scientific discipline (or equivalent experience) is essential.
- Additional preferred skills include strong organizational and problem-solving capabilities, experience with regulatory filings and compliance, and expertise in drug development and market analysis.
- A collaborative mindset, with the ability to thrive in a dynamic, research-focused environment.
This role provides significant potential for professional advancement within the clinical research domain, offering pathways for leadership and mentorship, thereby facilitating personal and career development in a dynamic and impactful setting.
Employment Type: Full-Time