Medical Director, Clinical Development Oncology

Medical Director, Clinical Development Oncology

AbbVie

Remote, Switzerland

Purpose:

Provides specialist medical and scientific strategic and operational input into core medical affairs activities such as: health-care professional and provider interactions, generation of clinical and scientific data, educational initiatives, and safeguarding patient safety. Works closely with sales, marketing, and commercial teams to provide strategic medical input into core brand strategies and support medical and marketing activates and market access.

Responsibilities:

• In cooperation with affiliate and functional areas, provides leadership, oversight and support for assigned products and projects;
• Establishes and approves scientific methods for hypotheses, rational, design of affiliate, Area, and Global protocols and their reports;
• Participation in design and execution of clinical trial safety, product safety, and risk management plans. Oversees the conduct of clinical trials and is medically and scientifically accountable for resolution of safety issues, interpretation of statistical analyses for clinical significance, and scientific documents are reports submitted to the regulatory authorities;
• Initiates medical affairs activities, generation, and dissemination of data supporting overall product scientific and business strategy;
• Provide scientific and medical education to investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information. Keep abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource;
• Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as the scientific team interface for key regulatory discussions;
• Act as the medical and scientific leader for projects within an area or across several areas;
• 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, and Global Medical Affairs sponsored or supported clinical research activities;
• Ensures budgets, timelines, compliance requirements are factored into programs’ scientific activities.

Qualifications:

• Medical Doctorate degree or equivalent with relevant therapeutic specialty in an academic or hospital environment. Completion of residency and/or fellowship is preferred;
• At least 2 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent;
• Proven leadership skills in a cross-functional global team;
• Ability to interact externally and internally to support a global business strategy;
• Extensive knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in development of strategy and the design of protocols.

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