Director II, Clinical Development
Director II, Clinical Development
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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 or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future. Salary: $177000- $336000
We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs
Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable 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.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Employment Type
Full-time
