Scientific Director / Senior Medical Director, Multiple Myeloma (International Medical Affairs)

Company Description

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Scientific Director / Senior Medical Director provides specialist medical and scientific input into core strategic and operational medical affairs activities such as: health-care professional and provider interactions; generation of clinical and scientific data (enhancing therapeutic benefit and value); 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 ideally based from our Mettawa, IL or Florham Park, NJ sites but other U.S. sites may be considered. Must follow a hybrid schedule of 3 days/week onsite.

Key Responsibilities:

1. Initiates medical affairs activities including data generation and dissemination strategy, development of Global Medical Affairs strategy, delivering the Medical Functional Plan, Brand Plan and working with Area and Affiliates to ensure execution of strategy.
2. 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.
3. 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. Provides in-house clinical expertise for the molecule and disease, coordinating appropriate scientific activities with internal stakeholders and leadership as they relate to ongoing clinical projects.
4. M.D.s may participate in design and execution of clinical trial safety; scientifically accountable for resolution of safety issues, safety monitoring, and other scientific reports reported to regulatory authorities. Review and assess all Adverse Events (AE’s) and Serious Adverse Events (SAE’s).
5. 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.
6. 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.
7. Interact with and coordinates appropriate scientific and medical activities with internal stakeholders (i.e., commercial, market access, HEOR, clinical operations, clinical development, regulatory, etc…) as they relate to on-going medical affairs projects.  Serve as the scientific team interface for key regulatory discussions.
8. 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.
9. Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities.
10. Responsible for understanding regulatory requirements related to clinical studies and global drug development and accountable for complying with those requirements.

Qualifications

Experience Requirements