MedicalScientific Director Pipeline - Rheumatology
MedicalScientific Director Pipeline - Rheumatology
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Medical/Scientific Director Pipeline Rheumatology:
- Provides specialist medical/scientific strategic and operational input into pipeline related medical affairs activities including but not limited to; medical and scientific strategies for the therapeutic franchise and/or multiple assets/indications deep therapeutic area and treatment data and insights synthesis external expert and provider interactions generation of clinical and scientific data (enhancing therapeutic benefit unmet medical need and added value to standards of care for patients); internal and external educational initiatives (medical education data guidelines and scientific communications and training).
- Develops and maintains professional relationships with External Experts develops innovative research concepts aligned to evidence gaps for clinical data generation.
- Works cross functionally within the pipeline commercialization matrix to provide strategic medical and scientific leadership and partnership into asset strategies.
- Operates in alignment with AbbVies business code of conduct policies and all applicable laws and regulations.
Responsibilities:
- Cochairs and leads as the medical function as Pipeline Medical Affairs Lead (PMAL) within the asset deliverable team framework of the pipeline commercialization strategic (PCS) model.
- Coleads and partners on the development of multiple asset strategies within the pipeline and strategic governance frameworks.
- Initiates medical affairs activities generation and dissemination of data supporting the overall pipeline scientific strategy.
- Builds and shapes the Pipeline Scientific Communication Strategy for multiple assets.
- May contribute to the design analyses interpretation and reporting of scientific content related to protocols Investigator Brochures Clinical Study Reports and regulatory submissions and responses.
- Leadership of external Medical Affairs activities such as but not limited to advisory boards congress support medical education programs training and symposia.
- May assist with the scientific review development approval and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities such as Investigator Initiated Studies (IIS) and collaborations.
- Leads and coordinates appropriate internal facing scientific and medical activities with internal stakeholders (i.e. commercial clinical operations discovery statistics regulatory etc) including but not limited to evidence gap workshops scientific platform and narrative external expert engagement mapping and planning ahead of key scientific meetings/congresses aligned to the Early Medical Functional Plan
- Provides scientific/medical education to investigators clinical monitors and Global Project Team members related to therapeutic area or disease specific information.
- Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource.
- Ensures budgets timelines compliance requirements are factored into medical affairs programs and scientific activities.
- Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements.
- Participates in the design and of clinical trial safety product safety and risk management plans. May also carry responsibility for routine and ad hoc safety monitoring reports to regulatory agencies.
There is a strong preference for this position to be based in Lake County IL however there could be a remote option
Qualifications :
- Medical Doctorate (M.D. degree or equivalent (D.O. or nonUS equivalent of M.D) or PhD in relevant field. Relevant therapeutic specialty in an academic or hospital environment preferred.
- NonMD: Minimum of 10 years of clinical development or medical affairs experience in the pharmaceutical industry or academia or equivalent. At least 5 years of experience within the pharmaceutical industry preferred.
- MD: Minimum of 5 years of clinical development or medical affairs experience in the pharmaceutical industry or academia or equivalent. At least 5 years preferred. At least 2 years of experience within the pharmaceutical industry preferred. Completion of residency and/or fellowship is preferred.
- Knowledge of clinical trial methodology with Good Clinical Practice (GCP) data analysis and interpretation regulatory requirements governing clinical trials and experience in development strategy and the design of protocols.
- Ability to run a clinical study independently with little supervision.
- Deep understanding of the clinical research and development process.
- Proven leadership skills in a crossfunctional global team environment.
- Ability to interact externally and internally to support global business strategies.
- Must possess excellent oral and written English communication skills.
- Experience working within the specific TA highly preferred
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
