Senior Medical Director, Immunology Clinical Development - Rheumatology

AbbVie Inc.; North Chicago (IL); Presencial; USD 211 000 - 401 000; Tempo integral

Resumo da oferta

AbbVie Inc. in the United States is seeking a Senior Medical Director for Immunology Clinical Development in Rheumatology.

The role leads design and execution of immunology-focused clinical programs, ensuring data quality, safety, and regulatory alignment, across global teams. The position requires MD/DO with substantial trial experience, and a track record in cross-functional leadership within a regulated environment.

Qualificações

• Medical Doctor (M.D.), Doctor of Osteopathy (D.O.) or non-US equivalent with relevant therapeutic specialty.
• At least 2 years of clinical trial experience in pharma, academia, or equivalent.
• Knowledge of regulatory and compliance requirements governing clinical trials.

Responsabilidades

• Oversees the design and implementation of one or more clinical development programs.
• Ensures study integrity and review of safety and efficacy data.
• Provides in-house clinical expertise and coordinates translational strategies.
• Collaborates with regulatory discussions and cross-functional teams.

Conhecimentos

Clinical trial management

Regulatory compliance

English communication

Cross-functional leadership

Formação académica

MD or DO

Residency completed

Descrição da oferta de emprego

Senior Medical Director, Immunology Clinical Development - Rheumatology

• Full-time


• Salary Min: 211000


• Therapy Area: Immunology


• Salary Max: 400500


• Workday Global Grade: 22


• Compensation: USD 211,000 - USD 400,500 - yearly

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

Oversees the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development programs. 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.


• Has 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 assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned.


• 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 oversee the work of Associate Medical and/or Scientific Directors, and of Clinical Scientists working on the same or related programs.


• Provides in-house clinical expertise for the molecule and disease, coordinating appropriate scientific and medical activities with internal stakeholders as they relate to ongoing clinical projects. May participate in 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.


• May serve on or chair a Clinical Strategy Team (CST), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In the role of CST Chair, responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to an Asset Development Team (ADT), ADT Leadership Board (ALB).


• 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 key regulatory discussions.


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

Senior 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 strongly preferred. Completion of a subspecialty fellowship is desirable.


• At least 2 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent.


• Ability to run a clinical research program of moderate complexity 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 development of clinical strategy and the design of study protocols.


• Must possess excellent oral and written English communication skills.

Executive 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 strongly preferred. Completion of a subspecialty fellowship is desirable.


• At least 5 years (7 years preferred) 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 through influence.


• 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 for one or more projects.

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.


• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.


• This job is eligible toparticipatein our long-term incentiveprograms.

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 ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable 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.