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Clinical Research Lead
2 months ago
About Allergan: Allergan is dedicated to discovering and delivering groundbreaking therapies and solutions that address significant health challenges today and prepare for the medical needs of the future.
Our commitment is to make a substantial difference in the lives of individuals across various therapeutic domains, including immunology, oncology, neuroscience, and eye care, alongside our offerings in the Allergan Aesthetics portfolio.
Position Overview: This role is primarily focused on providing expert medical and scientific strategic and operational contributions to essential medical affairs functions. These include:
- Engagement with healthcare professionals and providers.
- Generation of clinical and scientific data to enhance therapeutic value.
- Implementation of educational initiatives, including medical education and scientific communications.
- Ensuring patient safety through risk management and safety surveillance activities.
The position collaborates closely with commercial teams to offer strategic medical insights that inform core brand strategies and support medical affairs, marketing initiatives, and market access efforts.
Key Responsibilities:
- Lead medical affairs initiatives, including the generation and dissemination of data that supports the overarching scientific strategy.
- Oversee the design, analysis, interpretation, and reporting of scientific content for protocols, Investigator Brochures, Clinical Study Reports, and regulatory submissions.
- Ensure the integrity of clinical trials, being accountable for the resolution of safety issues and the interpretation of statistical analyses.
- Participate in the design and execution of clinical trial safety and risk management plans.
- Maintain oversight of clinical studies, monitoring overall study integrity and communicating accumulating data related to safety and efficacy.
- Facilitate scientific and medical education for investigators and clinical monitors, acting as a resource for therapeutic area knowledge.
- Ensure compliance with regulatory requirements related to clinical studies and global drug development.
Qualifications:
- Scientific Director: Advanced Degree (PhD or PharmD) with 7-10 years of experience in Medical Affairs, preferably with Global Medical Affairs experience. A minimum of 4 years in direct management of clinical trials within the pharmaceutical industry or academia is required.
- Medical Director: Medical Doctorate with relevant therapeutic specialty experience in an academic or hospital setting. At least 2 years of clinical trial or medical affairs experience is necessary.
Additional Information:
- We offer a comprehensive benefits package, including paid time off, medical/dental/vision insurance, and a 401(k) plan for eligible employees.
- This position is eligible for participation in short-term incentive programs.
- Allergan is committed to integrity, innovation, community service, and embracing diversity and inclusion in the workplace.