Scientific Director, Medical Affairs- CNS/Psychiatry
2 weeks ago
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
* Position can sit in our Lake County, IL or Madison, NJ offices.
The Scientific Director for US Medical Affairs in CNS/Psychiatry provides specialist medical and scientific strategic and operational input into core medical affairs activities such as: health-care professional and provider interactions; evidence generation of clinical and scientific data e.g., therapeutic benefit, safety and medical value); educational initiatives ,scientific communications, and digital engagement . Serve as a corecross-functional medical partner to fill gaps in the evidence and clinical practice through evidence generation, HEOR projects, publications, and external engagements to ensure the appropriate as safe use of our medicines. Work closely with commercial, marketing and sales teams to provide strategic medical input into core brand (product) strategies marketing activities (promotional material generation and product launches) and market access.
Responsibilities:
* Develops and initiates medical affairs activities, generation and dissemination of data supporting the overall scientific strategy.
* Lead or provide input into the design, analysis, interpretation, and reporting of scientific and medical data and information across study protocols, Investigator Brochures, Clinical Study Reports, publications/presentations and regulatory submissions and responses.
* Provides in-house clinical expertise for the molecule, disease, and evidence coordinating appropriate scientific activities with internal stakeholders as they relate to ongoing medical affairs and clinical projects. Serve as the voice of the patient and HCP in all activities.
* 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.
* 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 other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans, evidence-generation, publications, content generation, and protocols as appropriate.
* Assist in the development of scientifically accurate marketing materials, medical education programs, advisory boards, and symposia, among others. Assists with the scientific review, development, approval, execution, and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities.
* 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 HCPs, MSLs, investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information. Serves as a trusted therapeutic area resource for cross-functional teams, keeps abreast of treatment landscape, technological advances and therapeutic innovations through conferences and/or proactive mastery of the relevant medical literature
* Ensures projects are completed on time, on budget, and in compliance with regulatory. activities.
Qualifications
* Advanced Degree PhD or PharmD. Additional post doctorate experience highly preferred.
* Typically, 5-105 years of experience in the pharmaceutical industry or equivalent; substantial understanding of relevant therapeutic area required.
* 7-10 years of experience in Medical Affairs highly preferred.
* Minimum of 4 years of clinical trials experience in the pharmaceutical industry 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 Information
Applicable only to applicants
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