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Group Scientific Director Neuroscience Clinical Development
2 months ago
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 atwww.abbvie.com. Follow @abbvie onTwitter,Facebook,Instagram,YouTubeandLinkedIn.
Job DescriptionPurpose:
Manages Medical and/or Scientific Directors and leads the direction, planning, execution and interpretation of clinical trials or research activities of one or more clinical development programs. Participates in and may lead cross-functional teams to generate, deliver and disseminate high-quality clinical data supporting overall product scientific and business strategy.
Responsibilities:
Personally or through a direct report, 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, AbbVies customers, markets, business operations and emerging issues.
Oversees project-related education of investigators, study site personnel and AbbVie study staff. Responsibility may extend from early translational development activities to mature product lifecycle management strategies for internal and/or partnered programs.
Overall responsibility for leading and mentoring 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.
Manages one level of Medical and Scientific Directors (typically 2 to 4) and/or Clinical Scientists. This responsibility involves direct oversight of clinical development activities and/or management of personnel who may be working on other projects. Responsible for hiring, onboarding, mentoring, training and supporting career development of these individuals.
May chair Clinical 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 this capacity, responsibilities may include supervision of matrix team members and serving as the Clinical Research representative to lend clinical development and medical expertise to Asset Development Teams (ADTs) and ADT Leadership Boards (ALBs) and/or other cross-functional teams and internal stakeholders.
Serves as the in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific 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.
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Qualifications:
Bachelors degree in the sciences; advanced degree (e.g., MS, PhD) preferred.
At least 10 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 and manage through influence.
Demonstrated commitment to training and development of junior-level staff, using best judgment to assure that they work with an appropriate level of autonomy.
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 across multiple projects.
Ability to exercise judgment and address complex problems and create solutions across multiple projects.
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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 believesingood faith it will pay for this role at the time of this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, and we mayultimatelypay 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/visioninsurance 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 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 of compensationand benefitsthat are allocable to a particular employee remains in the Company's sole and absolute discretion unless anduntil paid andmay be modified at the Companys sole and absolute discretion, consistent with applicable law.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.