Senior Director Clinical Development
Senior Director Clinical Development
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Job Description
Leads the direction planning and interpretation of clinical studies and research activities of one or more aesthetic clinical development programs. Participates in and leads crossfunctional teams to generate deliver and disseminate highquality clinical data supporting overall botulinum toxin and aesthetic franchise scientific and business strategy.
Responsibilities:
- Lead with ownership the design and implementation of multiple aesthetic clinical development programs (or one large complex program) 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 projectrelated training of investigators study site personnel and AbbVie study staff.
- Lead global clinical study teams monitoring overall study integrity and review interpretation and communication of accumulating data pertaining to botulinum toxin safety and efficacy in varied indications. Along with Clinical Operations ensure agreedupon study enrollment and timelines for key deliverables including escalating and mitigating risks with multiple crossfunctional governance accountabilities.
- Drive design analysis interpretation and reporting of scientific content of protocols Investigator Brochures Clinical Study Reports regulatory submissions and responses and other program documents. Experience developing validating and defending new clinical outcome assessment instruments for use as clinical study endpoints is desirable.
- Oversee Medical and/or Scientific Directors and Clinical Scientists working on the same or related programs. Experience serving as line manager to clinical development staff including Medical and/or Scientific Directors and Clinical Scientists is desirable.
- Serve on or cochair Integrated Evidence Strategy Team(s) developing a rigorous crossfunctionallyaligned vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In the Clinical Study Team cochair role supervise matrix team members. Provide clinical development expertise to Asset Strategy Team(s) and multiple crossfunctional governance forums.
- Serve as inhouse clinical expert for one or more products and indications in aesthetics clinical development coordinating appropriate scientific and medical activities with internal stakeholders. Experience with clinical studies conducted in surgical settings is desirable.
- May participate in or lead clinical development contributions to 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.
- Solicit clinical opinion leader interactions 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 crossfunctional perspectives are incorporated into Integrated Evidence Plans Clinical Development Plans and protocols.
- 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 (eg MS PhD PharmD) preferred.
- At least 8 years of clinical study experience in pharmaceutical industry academia or equivalent.
- Ability to run a complex clinical development program independently.
- Proven leadership skills and ability to bring out the best in others on a crossfunctional global team. Must be able to lead through influence.
- Ability to interact externally and internally to support global scientific and business strategy.
- Extensive 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.
- Ability to exercise judgment and address complex problems and create solutions for one or more projects.
This position is based in Irvine CA.
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.
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 shortterm incentive programs.
This job is eligible to participate in our longterm 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 :
Fulltime
Employment Type
Full-time
