Scientific Director / Medical Director, Medical Affairs – Oncology
AbbVie
6 months ago
Remote friendly (Irvine, CA)
United States
Medical Affairs
Responsibilities:
- With oversight, initiate medical affairs activities; generate and disseminate data supporting the therapeutic area scientific strategy.
- Provide scientific/medical education to internal stakeholders on therapeutic area/disease-specific information.
- Develop and execute Medical Affairs support for priority clinical development trials.
- Contribute to development of, and lead execution of, Medical Education / Advisory Board & EE Engagement Plan aligned with TA plan; lead Global Conference planning and execution.
- Generate clinical and scientific data based on evidence gap assessment.
- Act as a clinical interface; solicit input through leader interactions; partner with Medical Affairs, Commercial, and other functions to incorporate cross-functional perspectives into clinical development plans and protocols.
- May perform detailed medical review of complex advertising and promotional materials for assigned therapeutic area(s), ensuring timely, accurate reviews in accordance with policies and regulatory guidelines.
- Coordinate scientific/medical activities with internal stakeholders (e.g., commercial, clinical operations, discovery, statistics, regulatory) for ongoing medical affairs projects.
- Serve as consultant/liaison with other corporations under licensing agreements and/or for new business development evaluations.
- Represent AbbVie at external meetings (investigator meetings, scientific association meetings, etc.).
- Ensure budgets, timelines, and compliance requirements are factored into scientific activities.
Qualifications:
- Scientific Director:
- Bachelor’s in sciences; PhD, PharmD, PA or NP preferred; residency or additional post-doctorate experience preferred.
- 5–7+ years in pharmaceutical industry (or equivalent) with substantial understanding of relevant therapeutic area.
- Medical Director:
- MD (or equivalent such as DO or non-US equivalent); relevant therapeutic specialty in academic/hospital environment preferred; residency and/or fellowship completion preferred.
- 0–2+ years pharmaceutical industry (or equivalent).
- Knowledge of clinical trial methodology; regulatory requirements for clinical trials; protocol design experience preferred.
- May have performed protocol design (academia) and/or acted as assistant PI.
- Ability to gain cooperation, present technical information, and communicate effectively (oral/written) to support global business strategy.
- Works with some supervision; exercises judgment within defined practices and policies.
- With oversight, initiate medical affairs activities; generate and disseminate data supporting the therapeutic area scientific strategy.
- Provide scientific/medical education to internal stakeholders on therapeutic area/disease-specific information.
- Develop and execute Medical Affairs support for priority clinical development trials.
- Contribute to development of, and lead execution of, Medical Education / Advisory Board & EE Engagement Plan aligned with TA plan; lead Global Conference planning and execution.
- Generate clinical and scientific data based on evidence gap assessment.
- Act as a clinical interface; solicit input through leader interactions; partner with Medical Affairs, Commercial, and other functions to incorporate cross-functional perspectives into clinical development plans and protocols.
- May perform detailed medical review of complex advertising and promotional materials for assigned therapeutic area(s), ensuring timely, accurate reviews in accordance with policies and regulatory guidelines.
- Coordinate scientific/medical activities with internal stakeholders (e.g., commercial, clinical operations, discovery, statistics, regulatory) for ongoing medical affairs projects.
- Serve as consultant/liaison with other corporations under licensing agreements and/or for new business development evaluations.
- Represent AbbVie at external meetings (investigator meetings, scientific association meetings, etc.).
- Ensure budgets, timelines, and compliance requirements are factored into scientific activities.
Qualifications:
- Scientific Director:
- Bachelor’s in sciences; PhD, PharmD, PA or NP preferred; residency or additional post-doctorate experience preferred.
- 5–7+ years in pharmaceutical industry (or equivalent) with substantial understanding of relevant therapeutic area.
- Medical Director:
- MD (or equivalent such as DO or non-US equivalent); relevant therapeutic specialty in academic/hospital environment preferred; residency and/or fellowship completion preferred.
- 0–2+ years pharmaceutical industry (or equivalent).
- Knowledge of clinical trial methodology; regulatory requirements for clinical trials; protocol design experience preferred.
- May have performed protocol design (academia) and/or acted as assistant PI.
- Ability to gain cooperation, present technical information, and communicate effectively (oral/written) to support global business strategy.
- Works with some supervision; exercises judgment within defined practices and policies.