Senior Scientific Director, Clinical Development - Oncology jobs in United States
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Allergan Aesthetics, an AbbVie Company · 20 hours ago

Senior Scientific Director, Clinical Development - Oncology

AbbVie is a company focused on discovering and delivering innovative medicines and solutions. They are seeking a Senior Scientific Director to lead clinical development programs in oncology, overseeing the design, implementation, and reporting of clinical trials while ensuring compliance with regulatory requirements.

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H1B Sponsor Likelynote

Responsibilities

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 strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations and emerging issues. Oversees project-related education of investigators, study site personnel and AbbVie study staff
May have responsibility for leading clinical study teams, monitoring overall study integrity and review, interpretation and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for ensuring agreed-upon study enrollment and overall timelines for key deliverables
Primary responsibility for and ownership of design, analysis, interpretation and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses and other program documents
May oversee the work of Medical and/or Scientific Directors and of Clinical Scientists working on the same or related programs
May serve on or co chair Integrated Evidence Strategy Team(s), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In the role of CST Co Chair, responsibilities may include supervision of matrix team members & serving as Clinical Research representative to lend clinical development and medical expertise to Asset Development Teams (ADTs) & ADT Leadership Boards (ALBs)
Serves as an in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific and medical activities with internal stakeholders as they relate to ongoing projects. May participate in or lead clinical development contributions to due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies
Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate
Stays abreast of professional information and technology through conferences, medical literature and other available training, to augment expertise in the therapeutic area. May represent AbbVie at key external meetings
Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions
Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research

Qualification

Clinical trial methodologyRegulatory complianceClinical strategy developmentOralWritten EnglishLeadership skillsIndependent program managementProblem-solvingCross-functional collaboration

Required

Bachelors degree in the sciences; advanced degree (e.g., MS, PhD) preferred
At least 8 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent
Ability to run a complex clinical research program independently
Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be 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 governing clinical trials and experience in development of clinical strategy and the design of study protocols
Must possess excellent oral and written English communication skills
Ability to exercise judgment and address complex problems and create solutions for one or more projects

Benefits

Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
Short-term incentive programs
Long-term incentive programs

Company

Allergan Aesthetics, an AbbVie Company

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At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products.

H1B Sponsorship

Allergan Aesthetics, an AbbVie Company has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2023 (1)
2022 (16)
2021 (14)
2020 (5)

Funding

Current Stage
Late Stage

Leadership Team

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Nicole Mowad-Nassar
Senior Vice President, AbbVie and President, Global Allergan Aesthetics
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