Medical Director Neuroscience Clinical Development
Medical Director Neuroscience Clinical Development
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Salary Not Disclosed
1 Vacancy
Job Description
Purpose
Oversees the direction planning execution and interpretation of clinical trials or research activities of a clinical development program. Participates in crossfunctional teams to generate deliver and interpret highquality 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 Development Plan based on strong medical and scientific principles knowledge of compliance and regulatory requirements AbbVies customers markets business operations and emerging issues. Oversees 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.
- 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 Associate Medical and/or Scientific Directors and of Clinical Scientists working on the same or related programs.
- Provides inhouse 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 a Clinical Subteam or its equivalent with responsibility for development of a rigorous crossfunctionallyaligned vetted Development Plan with full consideration of contingencies and alternative approaches. In the role as lead of the Clinical Subteam (or its equivalent) 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) AST Leadership Board (ALB) and/or other crossfunctional teams and internal stakeholders.
- 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 crossfunctional 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.) or nonUS equivalent of M.D. degree with relevant therapeutic specialty (Neurology or Psychiatry) Completion of a residency program in Psychiatry or Neurology strongly preferred.
- 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 crossfunctional 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 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
