Medical Director, Immunology Clinical Development

BioSpace; North Chicago (IL); On-site; USD 230,000 - 320,000; Full time

Job summary

AbbVie in Illinois seeks a Senior/Medical Director to oversee design, execution and interpretation of clinical trials within a development program, guiding cross-functional teams to deliver high-quality data supporting product strategy.

The role emphasizes regulatory compliance, protocol development, and collaboration with Medical Affairs, Clinical Operations and external partners to advance strategic objectives.

Qualifications

• Experience running clinical trials in pharma, academia, or equivalent.
• Knowledge of trial methodologies, regulatory and compliance requirements.
• Ability to design protocols and interact with global teams.
• Strong English communication skills, both written and spoken.

Responsibilities

• Oversee design and implementation of study protocols for a clinical development program.
• Monitor study integrity and data safety, and manage enrollment timelines.
• Contribute to analysis and reporting of clinical study data and regulatory submissions.
• Serve as clinical representative on a Clinical Strategy Team when needed.
• Lead cross-functional collaboration with Medical Affairs, Commercial and other functions.
• Stay current with professional information and regulatory requirements in drug development.

Skills

Clinical trial experience

Cross-functional collaboration

Regulatory knowledge

English communication

External engagement

Education

MD/DO or non-US equivalent

Residency program completion

Subspecialty fellowship desirable

Job description

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 atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Company Description

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 atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Job Description

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, AbbVies 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 Clinical 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.

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 strongly 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.

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.

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 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 to participate in our long-term incentiveprograms.

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 employer 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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html