Senior Medical Director, Clinical Development - Immunology
Senior Medical Director, Clinical Development - Immunology
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Salary Not Disclosed
1 Vacancy
Job Description
- 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 AbbVies customers markets business operations and emerging issues. Oversees projectrelated 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 agreedupon 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 crossfunctionallyaligned 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 inhouse 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 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. 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 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 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 crossfunctional 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 :
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 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:
No
Employment Type :
Fulltime
Employment Type
Full-time
