BioSpace
Program Lead II, Clinical Program Development
BioSpace, San Francisco, California, United States, 94199
Program Lead II, Clinical Program Development
Join to apply for the Program Lead II, Clinical Program Development role at BioSpace. Company Description AbbVie’s mission is to discover and deliver innovative medicines and solutions that help solve health issues today and address medical challenges of tomorrow. AbbVie aims to have a remarkable impact across key therapeutic areas including immunology, oncology, neuroscience, and eye care, and in the Allergan Aesthetics portfolio. For more information, visit us at www.abbvie.com. Follow AbbVie on social media. Job Description
The Clinical Operations Program Director is responsible for connecting science and operations to bring clinical studies to life through the execution of one or more clinical research programs. The Clinical Operations Program Director serves as a strategic advocate for pipeline assets and provides operational insight to scientific experiments via scientific expertise, strategic thinking, a global mindset, and innovative solutions to address risks and challenges. The Clinical Operations Program Director also serves as a people leader responsible for developing a pipeline of talent for the Development Operations organization. Responsibilities
Integral member of the Pipeline Commercialization Models Integrated Evidence Strategy Team and a strategic partner for the Asset Strategy Team and Development Review Committee to maximize the value of assets and portfolio for patients and AbbVie. Develop the clinical operational strategy aligned with asset strategy; responsible for execution of clinical studies/programs (e.g., operational timelines, enrollment options, assessment of patient population availability, balancing trial design complexity with speed). Evaluate risks and mitigations to achieving the asset strategy; identify strategic options for the Asset Strategy Team to evaluate amid competing priorities and unanticipated challenges. Influence and collaborate with management and cross-functional teams to achieve program objectives within Development Operations and with cross-functional colleagues who support clinical trial execution and with Therapeutic Area MDs/SDs in Global Medical Affairs. Contribute to portfolio planning, including development of costs, resource projections, and timelines for clinical development programs. Review and provide clinical operations input to clinical and regulatory documents (e.g., INDs, IB, NDAs, BLAs, MAA, Regulatory Briefing Books). Oversee external budget management across the portfolio (programs may range from $20M to $200M). Lead large, cross-functional innovation and process improvement initiatives with significant business impact and manage change across cross-functional areas supporting clinical program execution. Mentor and develop clinical operations staff (direct and indirect), including leadership development of 4–15 study managers and up to 30 indirect staff; foster an inclusive, innovative, and learning environment for staff and studies/programs to succeed. Ensure execution of clinical programs in compliance with quality standards (ICH/GCP, Global Regulations, AbbVie policies and procedures). Qualifications
Bachelor’s degree or equivalent required, typically in nursing or a scientific field. An Associate degree/R.N. or equivalent with relevant experience is acceptable. 12+ years of pharma/clinical research experience (or applicable work experience). 10 years (and/or applicable experience) in clinical research with a proven record of driving study strategy and leading a global team across multiple studies. Experience in risk management, decision-making, and strategic execution to ensure pipeline decisions are based on sound data. Strong communication skills and demonstrated coaching, mentoring, and people management (remote management experience preferred). Subject matter expert in standard business procedures (ICH, Global Regulations, Ethics and Compliance). Experience in study initiation through completion, primary data analysis, and/or multiple phases of studies (Phase I–III, 4). Additional Information
The compensation range described is the base pay range the Company believes in good faith it will pay for this role at posting time, based on job grade. Individual compensation may vary by location and may be modified in the future. Comprehensive benefits including paid time off, medical/dental/vision insurance, and 401(k) for eligible employees. Eligible for short-term and long-term incentive programs. Equal Opportunity Employer; Veterans/Disabled; US & Puerto Rico only - learn more at AbbVie join-us pages. Reasonable accommodations information available via AbbVie. EEO Statement
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. This includes Equal Opportunity Employer/Veterans/Disabled.
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Join to apply for the Program Lead II, Clinical Program Development role at BioSpace. Company Description AbbVie’s mission is to discover and deliver innovative medicines and solutions that help solve health issues today and address medical challenges of tomorrow. AbbVie aims to have a remarkable impact across key therapeutic areas including immunology, oncology, neuroscience, and eye care, and in the Allergan Aesthetics portfolio. For more information, visit us at www.abbvie.com. Follow AbbVie on social media. Job Description
The Clinical Operations Program Director is responsible for connecting science and operations to bring clinical studies to life through the execution of one or more clinical research programs. The Clinical Operations Program Director serves as a strategic advocate for pipeline assets and provides operational insight to scientific experiments via scientific expertise, strategic thinking, a global mindset, and innovative solutions to address risks and challenges. The Clinical Operations Program Director also serves as a people leader responsible for developing a pipeline of talent for the Development Operations organization. Responsibilities
Integral member of the Pipeline Commercialization Models Integrated Evidence Strategy Team and a strategic partner for the Asset Strategy Team and Development Review Committee to maximize the value of assets and portfolio for patients and AbbVie. Develop the clinical operational strategy aligned with asset strategy; responsible for execution of clinical studies/programs (e.g., operational timelines, enrollment options, assessment of patient population availability, balancing trial design complexity with speed). Evaluate risks and mitigations to achieving the asset strategy; identify strategic options for the Asset Strategy Team to evaluate amid competing priorities and unanticipated challenges. Influence and collaborate with management and cross-functional teams to achieve program objectives within Development Operations and with cross-functional colleagues who support clinical trial execution and with Therapeutic Area MDs/SDs in Global Medical Affairs. Contribute to portfolio planning, including development of costs, resource projections, and timelines for clinical development programs. Review and provide clinical operations input to clinical and regulatory documents (e.g., INDs, IB, NDAs, BLAs, MAA, Regulatory Briefing Books). Oversee external budget management across the portfolio (programs may range from $20M to $200M). Lead large, cross-functional innovation and process improvement initiatives with significant business impact and manage change across cross-functional areas supporting clinical program execution. Mentor and develop clinical operations staff (direct and indirect), including leadership development of 4–15 study managers and up to 30 indirect staff; foster an inclusive, innovative, and learning environment for staff and studies/programs to succeed. Ensure execution of clinical programs in compliance with quality standards (ICH/GCP, Global Regulations, AbbVie policies and procedures). Qualifications
Bachelor’s degree or equivalent required, typically in nursing or a scientific field. An Associate degree/R.N. or equivalent with relevant experience is acceptable. 12+ years of pharma/clinical research experience (or applicable work experience). 10 years (and/or applicable experience) in clinical research with a proven record of driving study strategy and leading a global team across multiple studies. Experience in risk management, decision-making, and strategic execution to ensure pipeline decisions are based on sound data. Strong communication skills and demonstrated coaching, mentoring, and people management (remote management experience preferred). Subject matter expert in standard business procedures (ICH, Global Regulations, Ethics and Compliance). Experience in study initiation through completion, primary data analysis, and/or multiple phases of studies (Phase I–III, 4). Additional Information
The compensation range described is the base pay range the Company believes in good faith it will pay for this role at posting time, based on job grade. Individual compensation may vary by location and may be modified in the future. Comprehensive benefits including paid time off, medical/dental/vision insurance, and 401(k) for eligible employees. Eligible for short-term and long-term incentive programs. Equal Opportunity Employer; Veterans/Disabled; US & Puerto Rico only - learn more at AbbVie join-us pages. Reasonable accommodations information available via AbbVie. EEO Statement
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. This includes Equal Opportunity Employer/Veterans/Disabled.
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