drjobs Executive Medical Director Neuroscience Clinical Development

Executive Medical Director Neuroscience Clinical Development

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1 Vacancy
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Job Location drjobs

North Chicago, IL - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Manages Medical and/or Scientific Directors and leads the direction planning execution and interpretation of clinical trials or research activities across several clinical development programs. May lead crossfunctional teams to generate deliver and disseminate highquality clinical data supporting overall product scientific and business strategy.  Acts as the overall leader of the Clinical Research function broadly across programs and disease areas.  As a teacher and mentor trains and guides both individuals and teams to help them execute effectively and achieve excellence in their assigned tasks.

Major Responsibilities:

  • Accountable for reports who lead and have ownership of the design and implementation of multiple clinical development programs in support of the overall product development plans based on strong medical and scientific principles knowledge of compliance and regulatory requirements AbbVies customers markets business operations and emerging issues. Ensures that staff provides projectrelated education of investigators study site personnel and AbbVie study staff. Responsibility may extend from early translational development activities to mature product lifecycle management strategies for internal and/or partnered programs.
  • Trains and lends expertise to staff who serve on Asset Development Teams (ADTs) and ADT Leadership Boards (ALBs) and who lead Clinical Strategy Teams (CSTs) and clinical study teams to ensure highquality crossfunctionallyaligned program (i.e. Clinical Development Plan) and study deliverables with full consideration of contingencies and alternative approaches.  Ensures that staff have capabilities to monitor overall study integrity study enrollment and timelines (along with Clinical Operations) and the review interpretation and communication of accumulating data pertaining to safety and efficacy of the molecule.  As needed provides senior expert medical judgment in the assessment and reporting of serious adverse events per corporate policy and regulations for those programs for which responsible.
  • Provides or ensures clarity regarding the appropriate level for review and approval of design analysis interpretation and reporting of scientific content of protocols Investigator Brochures Clinical Study reports regulatory submissions and responses and other program documents.  
  • In rare circumstances may lead a CST for an unusually complex highpriority program.  In this capacity responsibilities may include supervision of matrix team members and serving as the Clinical Research representative to lend clinical development and medical expertise to ADTs and ALBs and/or other crossfunctional teams and internal stakeholders.
  • Serves as the inhouse clinical and drug development expert broadly across several molecules and disease areas in the therapeutic area directing appropriate scientific activities with internal stakeholders as they relate to ongoing projects.   May lead clinical development contributions to due diligence or other business development activity.  Contributes in partnership with Discovery colleagues to design and implementation of translational strategies at a disease area and platform level.
  • Acts as a seniorlevel liaison for 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 crossfunctional perspectives are incorporated into disease area strategies and Clinical Development Plans as appropriate.
  • Stays abreast of professional information and technology through conferences medical literature and other available training to augment expertise in the therapeutic area.  Actively seeks opportunities to represent AbbVie at key external meetings and enhance AbbVies reputation as an industry leader.
  • Responsible for having deep understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a senior 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.) or nonUS 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 7 years (9 years preferred) of clinical trial experience in the pharmaceutical industry academia or equivalent.  Deep therapeutic area expertise strongly preferred.
  • Ability to prioritize across and help others effectively lead several complex clinical research programs.
  • Proven leadership skills and ability to bring out the best in others on a crossfunctional global team.  Must be able to lead and manage through influence.
  • Prior experience as a direct or matrixed manager with a demonstrated track record of training and development of juniorlevel staff using best judgment to assure that they work with an appropriate level of autonomy. 
  • 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 across multiple projects.


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 shortterm incentive programs. 

  • This job is eligible to participate in our longterm 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 serving our community and embracing diversity and inclusion.  It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.

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Remote Work :

No


Employment Type :

Fulltime

Employment Type

Full-time

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