BioSpace
Senior Scientific Director, Clinical Development - Consumer Eye Care Product Dev
BioSpace, Irvine, California, United States, 92713
Overview
Senior Scientific Director, Clinical Development - Consumer Eye Care Product Development 3 days ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people\'s lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Purpose
Leads cross-functional collaborations on identifying and developing consumer eyecare products (artificial tears, gels and ointments). Leads the direction, planning, and interpretation of clinical trials or research activities within consumer eye care innovation of one or more programs. Participates in and may lead cross-functional teams to generate, deliver, and disseminate high-quality data supporting consumer eye care product scientific and business strategy. Responsibilities
Serves as an in-house expert in identification and development of consumer eye care products. As required by program needs, in partnership with Discovery, Translational, and CMC colleagues contribute to design and implement translational strategies. May participate in or lead clinical development contributions to due diligence or other business development activity. Champions innovation in consumer eye care. Solicits opinion leader interactions related to the disease areas; partners with Medical Affairs, Commercial and other functions to ensure broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate. Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product development plan, based on medical and scientific principles, regulatory requirements, AbbVie customers, markets, business operations and emerging issues. Oversees study staff education. May lead clinical study teams, monitor study integrity, and communicate data pertaining to safety and efficacy. Ensures enrollment and timelines for key deliverables. Owns design, analysis, interpretation and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions, responses, and other program documents. May oversee the work of Medical and/or Scientific Directors and Clinical Scientists on related programs. May serve on or co-chair Integrated Evidence Strategy Team(s), developing a cross-functionally-aligned Clinical Development Plan with contingencies and alternative approaches. As Co-Chair, may supervise matrix team members and represent clinical development to Asset Development Teams. Stays current with professional information and technology; may represent AbbVie at external meetings. Responsible for understanding regulatory requirements related to clinical studies and global drug development; serves as a clinical representative for key regulatory discussions. Ensures adherence to Good Clinical Practices, pharmacovigilance standards, SOPs, and other quality standards in research. Qualifications
Bachelors degree in the sciences; advanced degree (e.g., MS, PhD, OD, MD, PharmD) preferred. At least 8 years of product development experience with 5 years of consumer eye care experience in pharma, academia, or equivalent. Direct Experience In Leading Cross-functional And Translational Development Preferred. Ability to run a complex clinical research program independently. Proven leadership skills and ability to lead a cross-functional global team; able to lead through influence. Ability to interact externally and internally to support a global scientific and business strategy. Extensive knowledge of clinical trial methodology, regulatory and compliance requirements; experience in clinical strategy and protocol design. Excellent spoken and written English communication skills. Ability to address complex problems and create solutions for one or more projects. Additional Information
The compensation range described below is the range of possible base pay compensation; final pay depends on location and other factors. We offer a comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k) for eligible employees. This job is eligible for short-term and long-term incentive programs. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Senior Scientific Director, Clinical Development - Consumer Eye Care Product Development 3 days ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people\'s lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Purpose
Leads cross-functional collaborations on identifying and developing consumer eyecare products (artificial tears, gels and ointments). Leads the direction, planning, and interpretation of clinical trials or research activities within consumer eye care innovation of one or more programs. Participates in and may lead cross-functional teams to generate, deliver, and disseminate high-quality data supporting consumer eye care product scientific and business strategy. Responsibilities
Serves as an in-house expert in identification and development of consumer eye care products. As required by program needs, in partnership with Discovery, Translational, and CMC colleagues contribute to design and implement translational strategies. May participate in or lead clinical development contributions to due diligence or other business development activity. Champions innovation in consumer eye care. Solicits opinion leader interactions related to the disease areas; partners with Medical Affairs, Commercial and other functions to ensure broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate. Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product development plan, based on medical and scientific principles, regulatory requirements, AbbVie customers, markets, business operations and emerging issues. Oversees study staff education. May lead clinical study teams, monitor study integrity, and communicate data pertaining to safety and efficacy. Ensures enrollment and timelines for key deliverables. Owns design, analysis, interpretation and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions, responses, and other program documents. May oversee the work of Medical and/or Scientific Directors and Clinical Scientists on related programs. May serve on or co-chair Integrated Evidence Strategy Team(s), developing a cross-functionally-aligned Clinical Development Plan with contingencies and alternative approaches. As Co-Chair, may supervise matrix team members and represent clinical development to Asset Development Teams. Stays current with professional information and technology; may represent AbbVie at external meetings. Responsible for understanding regulatory requirements related to clinical studies and global drug development; serves as a clinical representative for key regulatory discussions. Ensures adherence to Good Clinical Practices, pharmacovigilance standards, SOPs, and other quality standards in research. Qualifications
Bachelors degree in the sciences; advanced degree (e.g., MS, PhD, OD, MD, PharmD) preferred. At least 8 years of product development experience with 5 years of consumer eye care experience in pharma, academia, or equivalent. Direct Experience In Leading Cross-functional And Translational Development Preferred. Ability to run a complex clinical research program independently. Proven leadership skills and ability to lead a cross-functional global team; able to lead through influence. Ability to interact externally and internally to support a global scientific and business strategy. Extensive knowledge of clinical trial methodology, regulatory and compliance requirements; experience in clinical strategy and protocol design. Excellent spoken and written English communication skills. Ability to address complex problems and create solutions for one or more projects. Additional Information
The compensation range described below is the range of possible base pay compensation; final pay depends on location and other factors. We offer a comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k) for eligible employees. This job is eligible for short-term and long-term incentive programs. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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