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Lead Clinical Pharmacology Strategist
2 months ago
Company Overview:
AbbVie is dedicated to the discovery and delivery of groundbreaking therapies that address significant health challenges today and in the future. Our commitment spans various therapeutic areas, including immunology, oncology, neuroscience, and eye care, along with our offerings in the Allergan Aesthetics portfolio. For further details about AbbVie, please visit our website.
The Associate Director of Clinical Pharmacology is responsible for devising, implementing, and effectively communicating comprehensive Clinical Pharmacology development strategies that align with commercial objectives and regulatory standards across multiple disciplines. This role involves generating innovative PK/PD study proposals and spearheading these initiatives. The position requires anticipating and critically assessing advancements in Clinical Pharmacology, PK/PD, or regulatory matters, identifying strengths, weaknesses, opportunities, and threats, and responding with suitable new strategies. A proven track record in achieving Clinical Pharmacology and business goals is essential.
Key Responsibilities:- Oversee the design of Phase 1-4 studies and clinical pharmacology strategies, serving as the primary representative for assigned projects.
- Implement strategies, lead teams, and conduct various data analyses, providing necessary context, including mechanisms of action and disease specifics.
- Prepare regulatory documentation, including protocols, study reports, population PK reports, exposure-response analyses, and other relevant documents.
- Facilitate clinical pharmacology and biopharmaceutics meetings, representing Clinical Pharmacology on various cross-functional teams.
- Lead small teams comprising members from Clinical Pharmacology functional groups to present a cohesive clinical pharmacology perspective.
- Contribute to scientific publications and present findings at national and international conferences while engaging with key opinion leaders and external stakeholders.
- Conduct due diligence assessments, summarize findings, and represent Clinical Pharmacology in business development initiatives.
- Act as the Clinical Pharmacology representative in regulatory discussions.
*This position requires on-site presence three days a week.*
- PhD with a minimum of 4 years of relevant experience, or Pharm D with at least 6 years of experience, or a Master's Degree with 12+ years of experience, or a Bachelor's Degree with 14+ years of experience in relevant fields such as PK, PBPK, PK-PD, Pharmacometrics, or systems pharmacology.
- Exceptional interpersonal skills and the ability to collaborate with functional representatives and key opinion leaders.
- Strategic mindset with a comprehensive understanding of enterprise objectives.
- Demonstrated scientific expertise and technical proficiency relevant to the role.
- Key Leadership Competencies:
• Achieves business results while positioning AbbVie for sustainable success.
• Demonstrates persistence and resilience in advancing innovative ideas.
• Acts with respect and courage.
• Connects disparate concepts to generate original ideas.
• Influences colleagues to foster cross-functional alignment.
• Takes full accountability in delegating tasks and accepting responsibilities.
AbbVie is an equal opportunity employer committed to diversity and inclusion. We value the contributions of all individuals and strive to create an inclusive environment where everyone can thrive.
