What are the responsibilities and job description for the Senior Director, Clinical Development position at Allergan Aesthetics, an AbbVie Company?
Job Description
Leads the direction, planning, execution, and interpretation of clinical studies and research activities of one or more aesthetic clinical development programs. Participates in and leads cross-functional teams to generate, deliver, and disseminate high-quality 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, AbbVie’s customers, markets, business operations, and emerging issues. Oversee project-related 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 agreed-upon study enrollment and timelines for key deliverables, including escalating and mitigating risks with multiple cross-functional 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 co-chair Integrated Evidence Strategy Team(s) developing a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In the Clinical Study Team co-chair role, supervise matrix team members. Provide clinical development expertise to Asset Strategy Team(s) and multiple cross-functional governance forums.
Serve as in-house 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 cross-functional 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.
Leads the direction, planning, execution, and interpretation of clinical studies and research activities of one or more aesthetic clinical development programs. Participates in and leads cross-functional teams to generate, deliver, and disseminate high-quality 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, AbbVie’s customers, markets, business operations, and emerging issues. Oversee project-related 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 agreed-upon study enrollment and timelines for key deliverables, including escalating and mitigating risks with multiple cross-functional 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 co-chair Integrated Evidence Strategy Team(s) developing a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In the Clinical Study Team co-chair role, supervise matrix team members. Provide clinical development expertise to Asset Strategy Team(s) and multiple cross-functional governance forums.
Serve as in-house 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 cross-functional 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.