Executive Medical Director - Neuroscience Clinical Development - Toxins

AbbVie; Waltham (MA); On-site; USD 180,000 - 270,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Long-term incentives

Paid time off

Job summary

AbbVie, a global biopharmaceutical leader, seeks a senior clinical development professional to lead multi-program trials and coordinate cross-functional teams across drug development areas. You will oversee safety, efficacy data, and regulatory submissions while guiding investigators and study staff.

The ideal candidate has MD/DO, 5–7 years of trial experience, and strong leadership with excellent English communication.

Qualifications

• MD/DO or non-US equivalent with relevant therapeutic specialty in an academic or hospital environment. Residency completion strongly preferred; subspecialty fellowship desirable.
• At least 5–7 years 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 lead a cross-functional global team; able to 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; experience in development of clinical strategy and study design.
• Excellent oral and written English communication skills.
• Ability to exercise judgment and address complex problems and create solutions.

Responsibilities

• Leads and demonstrates ownership of design and implementation of multiple clinical development programs in support of the overall product development plan.
• Oversees study teams, monitors study integrity, and reviews data on safety and efficacy; ensures enrollment and timelines for key deliverables.
• Design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, and regulatory submissions.
• Oversees work of Medical/Scientific Directors and Clinical Scientists on related programs.
• Serves on Clinical Strategy Teams; develops a rigorous Clinical Development Plan with cross-functional alignment.
• Acts as in-house clinical expert coordinating scientific activities with internal stakeholders; may participate in due diligence or translational work.
• Represents AbbVie in external meetings; ensures adherence to Good Clinical Practices and regulatory requirements.

Skills

Leadership

Clinical Trials

Regulatory Knowledge

English Communication

Education

MD/DO or foreign equivalent

Residency preferred

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

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

Leads the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development programs. Participates in and may lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data supporting overall product scientific and business strategy.

Responsibilities

• Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex 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 overall responsibility for leading clinical study teams, 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 ensuring agreed-upon 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.
• Primary responsibility for and ownership of 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 and/or Scientific Directors and of Clinical Scientists working on the same or related programs.
• May serve on or chair Clinical Strategy Team(s), 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 Asset Development Teams (ADTs) and ADT Leadership Boards (ALBs).
• Serves as an in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific and medical activities with internal stakeholders as they relate to ongoing projects. May participate in or lead clinical development contributions to 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.
• Acts as clinical lead and actively solicits 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, 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. May represent AbbVie at key external meetings.
• 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 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.

Additional Information

• 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