Job DescriptionThe Senior Medical Director/Scientific Director, Medical Affairs provides specialist medical and scientific strategic and operational input into core medical affairs activities for AbbVie's Rheumatology SpA Therapeutic Area.
Responsibilities include engaging with health-care professionals and providers; generating clinical and scientific data to enhance the therapeutic benefit and value of our SpA portfolio assets; educational initiatives (medical education, scientific communications, and value proposition) and safeguarding patient safety (risk minimization activities and safety surveillance activities).
Works closely with sales, marketing, and commercial teams to provide strategic medical input into core brand (product) strategies, and to support medical affairs, marketing activities (promotional material generation and product launches) and market access.
This position is based at the Mettawa, IL office or one of other locations and will follow a hybrid schedule of 3x/week onsite.
Responsibilities:
- Initiates medical affairs activities, generation and dissemination of data supporting the overall scientific strategy.
- Responsible from Medical Affairs for the design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports and regulatory submissions and responses.
- Has overall responsibility for oversight of the Medical Affairs-led clinical studies, monitoring overall study integrity and review, interpretation and communication of accumulating data pertaining to safety and efficacy of the molecule. As the SD Study Lead, is responsible for oversight of study enrollment and overall timelines for key deliverables.
- Provides in-house clinical expertise for the molecule and disease, coordinating appropriate scientific 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 partnering with Discovery colleagues on the design and implementation of translational strategies.
- Acts as a clinical interface and actively solicits opinion through 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.
- May assist in the development of scientifically accurate marketing materials, medical education programs, advisories, and symposia. Assists with the scientific review, development, approval, execution, and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities.
- May interact with and coordinates appropriate scientific and medical activities with internal stakeholders (i.e., commercial, clinical operations, discovery, statistics, regulatory, etc.) as they relate to on-going medical affairs projects. Serves as the scientific team interface for key regulatory discussions.
- Provide 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 programs' scientific activities.
Qualifications- Advanced Degree PhD or PharmD. Additional post doctorate experience highly preferred.
- 7-10 years of experience in Medical Affairs with Global Medical Affairs experience highly preferred.
- Typically, 10-15 years of experience in the pharmaceutical industry or equivalent; substantial understanding of relevant therapeutic area required.
- Minimum of 4 years of clinical trials direct management experience in the pharmaceutical industry or academia or equivalent. 4+ years of experience is preferred.
- Knowledge of clinical trial methodology, 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.
- Proven leadership skills in a cross-functional global team environment.
- Must possess excellent oral and written English communication skills.
Additional InformationApplicable 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 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 Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
