Senior Medical Director, Neuroscience Clinical Development

BioSpace; North Chicago (IL); Sur place; USD 180 000 - 260 000; Plein temps

Résumé du poste

AbbVie is seeking an MD/DO or equivalent to lead clinical development efforts across one or more programs, guiding study design, data interpretation, and regulatory submissions. The role requires collaboration with cross-functional teams to advance scientific and business strategy while ensuring compliance with GCP and regulatory standards.

The candidate should have at least 2 years of clinical trial experience and strong English communication skills, with a preference for experience in

Qualifications

• MD/DO or non-US equivalent with relevant therapeutic specialty.
• Residency completion strongly preferred; subspecialty fellowship desirable.
• At least 2 years of clinical trial experience in pharma, academia, or equivalent.
• Experience with psychedelic drug development highly preferred.
• Ability to run a clinical research program of moderate complexity with minimal supervision.
• Ability to work cross-functionally in a global team.
• Knowledge of clinical trial methodology and regulatory requirements.
• Excellent oral and written English communication skills.

Responsabilités

• Design and implement one or more clinical development programs within an overall Product Development Plan.
• Oversee study enrollment and timelines; monitor study integrity and safety/efficacy data.
• Prepare and report protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions.
• Serve as clinical expert and coordinate activities with internal stakeholders.
• May chair an Integrated Evidence Strategy Team (IEST) and supervise matrix team members.
• Engage with external stakeholders and participate in translational strategy development.
• Stay current on regulatory requirements and Good Clinical Practices.

Connaissances

Clinical trial management

Cross-functional teamwork

Regulatory knowledge

English proficiency

Formation

Medical degree (MD/DO)

Description du poste

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

Job Description

Purpose

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 Medical Directors 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 an Integrated Evidence Strategy Team (IEST), 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 IEST 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 Strategy Team (AST)

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.

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.

Experience With Psychedelic Drug Development Highly Preferred

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 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 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 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