Scientific Director, Medical Affairs Global Oncology Pipeline
1 day ago
AbbVie is a leading global biopharmaceutical company committed to discovering and delivering innovative medicines and solutions that address serious health issues. We are seeking a highly skilled and experienced Scientific Director, Medical Affairs Global Oncology Pipeline to join our team.
The successful candidate will be responsible for providing strategic and operational input into core medical affairs activities, including health-care professional and provider interactions, generation of clinical and scientific data, educational initiatives, and safeguarding patient safety. They will work closely with clinical development teams to support trial enrollment and evidence generation, and with commercial teams to provide strategic medical input into core brand strategies and support marketing activities.
The ideal candidate will have a strong background in clinical trial methodology, data analysis, and interpretation, as well as experience in development strategy and the design of protocols. They will possess excellent leadership skills, with the ability to interact externally and internally to support global business strategy. A PhD or PharmD degree, with additional postdoctoral experience, is highly preferred.
This is a challenging and rewarding role that requires a high level of expertise, strategic thinking, and collaboration. If you are a motivated and experienced professional looking to make a meaningful contribution to the field of oncology, we encourage you to apply.
Responsibilities:
- Generate and lead Medical Affairs strategies for GI oncology pipeline
- Initiates medical affairs activities, generation and dissemination of data supporting the overall scientific strategy
- Contributes to the development of brand strategies
- Generates clinical and scientific data per evidence gap assessment
- Aligns Medical education and scientific initiatives with Sci Comm Platform
- Participates in the externally sponsored studies review and recommendations for approval for assets under his/her responsibility
- Contributes to the development of and leads the execution of the Medical Education / Advisory Board & EE Engagement Plan generation in line with TA plan
- Contributes to the generation of MI communication content and supports training on Medical Information (MI) materials
- Develops and executes Medical Affairs support of priority clinical development trials
- Responsible for the design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports and regulatory submissions and responses
- May oversee the conduct of clinical trials and is medically and scientifically accountable for resolution of safety (AE's & SAE's) issues, interpretation of statistical analyses for clinical significance, PI selection, scientific documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities
- May participate in design and execution 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
- May review, assess and report applicable Adverse Events (AE's) and Serious Adverse Events (SAE's) if assigned to AbbVie conduct on clinical studies
- 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 coordinate 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
- 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 programs' scientific activities
- Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements
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