Associate Medical DirectorScientific Director, Clinical Development Immunology

Medical Director 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 Integrated Evidence 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.

Scientific Director Job Description

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:

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 AbbVies customers markets business operations and emerging issues. Oversees project-related education of investigators study site personnel and AbbVie study staff.

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 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 an Integrated Evidence Strategy Team with responsibility for development of a rigorous cross-functionally-aligned vetted Clinical Development Plan with full consideration of contingencies and alternative approaches

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 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 in rheumatology or some experience in rheumatology clinical research especially lupus is 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.

Scientific Director Qualifications

Bachelors degree in the sciences; advanced degree (e.g. MS PhD PharmD) preferred.

Some experience in rheumatology clinical research especially lupus is preferred.

Ability to provide input and direction to clinical research with appropriate supervision.

At least 4 years of clinical trial experience in the pharmaceutical industry academia or equivalent.

Ability to oversee a clinical research program of moderate complexity with minimal supervision.

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 short-term incentive programs. 

• 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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time