Job Description

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 . Follow @abbvie on , , , , and .

Medical Director
With supervision, oversees the direction, planning, execution and interpretation of clinical trials or research activities of a clinical development program. Participates in cross-functional teams to generate, deliver, and interpret high-quality clinical data supporting overall product scientific and business strategy.
Responsibilities:
With appropriate supervision, manages the design and implementation of study
protocols for a clinical development program in support of 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. Oversees project-related education of
investigators, study site personnel, and AbbVie study staff.
Has responsibility for oversight of clinical studies, 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 oversight of study enrollment and overall timelines for key
deliverables. Responsible for assessment and reporting of serious adverse events
per corporate policy and regulations for those protocols on which assigned.
Contributes to design, analysis, interpretation, and reporting of scientific content
of protocols, Investigator Brochures, Clinical Study Reports, regulatory
submissions and responses, and other program documents.
May serve on a Integrated Evidence Strategy Team as the clinical representative for
the protocols for which the incumbent has responsibility. Contributes to the
development of a rigorous, cross-functionally-aligned, vetted Clinical
Development Plan in collaboration with matrix team members.
Participates in 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.
Stays abreast of professional information and technology through conferences,
medical literature, and other available training, to augment expertise in the
therapeutic area.
Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. May be asked to contribute to regulatory responses and discussions. Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
Scientific Director
Oversees the direction, planning, execution and interpretation of clinical trials or research activities of a clinical development program. Participates in cross-functional teams to generate, deliver and interpret high-quality clinical data supporting overall product scientific and business strategy.
Responsibilities:

• Manages the design and implementation of one or more clinical development programs in support of an 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. Oversees project-related education of investigators, study site personnel and AbbVie study staff.

• Overall responsibility for oversight of clinical studies, 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 oversight of study enrollment and overall timelines for key deliverables.

• 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.

• May serve on an Integrated Evidence Strategy Team, with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches

• Acts as a clinical interface and actively solicits opinion leader interactions related to the molecule and disease area; 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.

• Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for regulatory responses and discussions.

• Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.

Qualifications
Medical Director Qualifications
Medical Doctor (M.D), Doctor of Osteopathy (D.O.), or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program in rheumatology or some experience in rheumatology clinical research, especially lupus, is preferred.
Ability to run a clinical research study with appropriate supervision.
Strong desire to collaborate in a cross-functional setting.
Clinical trial experience in the pharmaceutical industry, academia, or equivalent is preferred.
Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in the design of study protocols is desirable.
Ability to interact externally and internally to support global scientific and business strategy.
Must possess excellent oral and written English communication skills.
Scientific Director Qualifications

• Bachelors degree in the sciences; advanced degree (e.g., MS, PhD, PharmD) preferred.

• Some experience in rheumatology clinical research, especially lupus, is preferred.

• Ability to provide input and direction to clinical research with appropriate supervision.

• At least 4 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent.

• Ability to oversee a clinical research program of moderate complexity with minimal supervision.

• 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 development of clinical strategy and the design of study protocols.

• 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. ?
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 Company's sole and absolute discretion unless and until paid and may be modified at the Company's 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
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Skills Required