Medical Director, Immunology Clinical Development

AbbVie; Massachusetts; On-site; USD 230,000 - 320,000; Full time

Benefits offered by this job

401(k)

Health benefits

Paid time off

Job summary

AbbVie is seeking a Medical Director/Senior Medical Director to oversee clinical development programs, design studies, ensure regulatory compliance, and drive high-quality data across therapeutic areas. You will lead cross-functional teams and contribute to strategic plans for pivotal trials.

With supervision, you will manage enrollment, timelines, safety data and regulatory submissions, collaborating closely with Medical Affairs, Commercial and other functions to advance the program and global

Qualifications

• Medical degree with relevant therapeutic specialty; residency preferred.
• Ability to run a clinical research study with supervision.
• Strong collaboration in cross-functional settings.
• Clinical trial experience in pharma or academia preferred.
• Knowledge of regulatory requirements governing trials.
• Must possess excellent oral and written English communication skills.

Responsibilities

• Oversee design and implementation of study protocols for a clinical development program.
• Monitor study integrity, assess safety and efficacy data, oversee enrollment and timelines.
• Contribute to analysis, reporting, and regulatory submissions and responses.
• May serve on Clinical Strategy Team and develop Clinical Development Plan with matrix partners.

Skills

Clinical trial design

Regulatory compliance

Cross-functional collaboration

English communication

Project leadership

Education

Medical Doctor (M.D.) or D.O.

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 at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

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 businessstrategy.

Responsibilities:

• Withappropriate 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,monitoringoverall study integrity, and review, interpretation, and communication of accumulating datapertaining tosafety and efficacy of the molecule.Along with Clinical Operations,is responsible foroversight 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.
• Participatesin opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities asrequired, consistent with corporate policies.
• Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augmentexpertisein the therapeutic area.
• Responsible for understanding the regulatory requirements related tothe clinicalstudies and global drug development and accountable forcomplying withthose 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.

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.
• 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.

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 thisposting 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 anduntil 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.

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