AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
The role is focused on driving core medical affairs activities to support the US Neuroscience franchise in Psychiatry. Examples of these activities are as follows: health-care professional/provider interactions; generation of clinical and scientific data; medical education initiatives; and safeguarding patient safety (risk minimization activities / safety surveillance activities). The role also works closely with the US Commercial Team and Global Clinical Development Team(s) to provide strategic medical input into core brand (product) strategies, medical/marketing activities (promotional material generation/product launches), market access, and clinical development strategies to ensure relevance to the US marketplace.
In addition, the role provides scientific and technical support for assigned products; delivers scientific presentations; develops and maintains professional and credible relationships with key opinion leaders and key external organizations; actively participates in relevant asset development teams; develops medical affairs strategies for assigned products; develops innovative research concepts for clinical data generation; provides relevant scientific and technical training; and serves a key role on the Integrated Brand Team (IBT).
This role will be primarily focused on supporting VRAYLAR (cariprazine) with additional focus also on its approved indications (schizophrenia and bipolar disorder). It will indirectly support investigational indications; however, it will require very strong partnership with US Scientific Director responsible for those indications.
- Ensuring the generation and dissemination of data to support the overall product scientific and business strategy.
- Partnership with the US Commercial team to ensure all materials, strategies, and tactics are scientifically/medically balanced and accurate.
- Generates and maintains the Scientific Communication Platform for each assigned asset and contributes to the maintenance of the plan in close relationship with the GMAT Leads.
- Drives the overall research platform for VRAYLAR in the US. This includes the ability to evaluate and execute various types of research (i.e. Phase IIIb-IV,epi, EDA, RWE).
- Participates in the design and execution of clinical trial and product safety risk management plans. May also carry responsibility for routine and ad-hoc safety monitoring reports to regulatory agencies, assessment and report applicable Adverse Events (AE’s)/Serious Adverse Events (SAE’s).
- Provides scientific/medical education to investigators, study coordinators, External Experts, and a variety of internal stakeholders.
- Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource.
- Leads the development of medical education programs, publication strategies, advisory boards, and symposia.
- Acts as the medical affairs representative in the joint development committee with Gideon Richter
- Ensures tactics are completed on time, on budget, and in full compliance with policies and procedures.
- This role does not supervise employees but must be able to influence in a matrixed environment. Works mostly independently with limited guidance.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
- Life Sciences high degree (PharmD, MSc with PhD) or equivalent with relevant therapeutic specialty in an academic or hospital environment.
- Minimum of 2 years of clinical trial or medical affairs experience in the pharmaceutical industry. Additional years of experience in a clinical, academic, or medical education setting would be a plus.
- Proven leadership skills and an ability to interact externally and internally to support business strategy.
- Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols.
- Expertise in Psychiatry is preferred.
- Must possess excellent oral and written communication skills.
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Yes, 10 % of the Time
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.