Director II, Clinical Development

Job Details

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 at www.abbvie.com . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok .

Job Description

At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more.

With our own research and development team focused on driving innovation in aesthetics, were committed to providing the most comprehensive science-based product offerings available.

The Director II, Clinical Development will oversee the direction, planning, execution, and interpretation of clinical studies and research activities of aesthetic clinical development programs. Participates in and leads cross-functional teams to generate, deliver, and interpret high-quality clinical data supporting overall botulinum toxin and aesthetic franchise scientific and business strategy.

Responsibilities:

• Manages the design and implementation of one (complex) or more aesthetic clinical development programs supporting the overall product development plan based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVies customers, markets, business operations and emerging issues. Oversee project-related training of investigators, study site personnel, and AbbVie study staff.
• Oversee global clinical study teams monitoring overall study integrity and review, interpretation, and communication of accumulating data pertaining to botulinum toxin safety and efficacy in aesthetic indications. Along with Clinical Operations, ensure overall timelines for programs.
• Responsible for design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses and other program documents. Lead development, validation, and justification of new clinical outcome assessment instruments for use as clinical study endpoints.
• Oversee Scientific Directors and/or of Clinical Scientists working on the same or related programs. Serve as line manager for up to 5 clinical development staff.
• Serve as in-house clinical lead for one or more products and indications in aesthetics clinical development, coordinating appropriate scientific and medical activities with internal stakeholders. May participate in due diligence or other business development activity. As required by program needs, partner with Research and Clinical Pharmacology colleagues to design and implement translational strategies.
• May lead an Integrated Evidence Strategy Team (IEST), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Integrated Evidence Plan / Clinical Development Plan with full consideration of contingencies and alternative approaches.
• Act as clinical interface for study investigators and solicit consultant or opinion leader input related to the indication(s); partner with Medical Affairs, Commercial, and other functions in these activities as required, consistent with corporate policies, to ensure broad cross-functional perspectives are incorporated into study protocols as appropriate.
• Stay abreast of professional information and technology through conferences, medical literature reviews, and other available training, to augment expertise in the therapeutic area. May represent AbbVie at key external meetings.
• Demonstrate understanding of regulatory requirements related to botulinum toxin and aesthetic clinical studies and global drug development, exemplifying compliance with those requirements. Provide clinical development expertise for key regulatory discussions. Accurately summarize and communicate complex scientific and regulatory objectives for study team, internal governance, clinical opinion leaders, and global health authority meetings.
• Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.

Qualifications

• Bachelors degree in the sciences; advanced degree (e.g., MS, PhD, PharmD) preferred.
• Ability to provide input and direction to clinical research with appropriate supervision.
• At least 5 years of clinical study experience in the pharmaceutical industry, academia, or equivalent.
• Ability to oversee a complex clinical research program with minimal supervision.
• Ability to perform and bring out the best in others on a cross-functional global team.
• Ability to interact externally and internally to support a global scientific and business strategy.
• Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in clinical strategy development and study design.
• Must possess excellent oral and written English communication skills.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible to participate in our short-term incentiveprograms.
• This job is eligible to participate in our long-term incentiveprograms

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law.

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.

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