Director - Medical Immunology, Oncology, Neurology - AbbVie - Chicago

Job description
The Medical Director, Immunology, Oncology or Neurology oversees the direction, planning, execution, and interpretation of clinical trials/research and the data collection activities. Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. May recruit clinical investigators and negotiates study design. Responsible for creating clinical development plans and for directing human clinical trials, phase I – IV for company products under development. Responsibilities also include adverse event reporting and safety responsibilities monitoring. Coordinates and develops reporting information for reports submitted to Global Regulatory Authorities including EMEA, FDA and other national authorities. Monitors adherence to protocols and determines study completion. Acts as consultant/liaison with other corporations when working under licensing agreements.

Key responsibilities:
Accountable for the design and management of clinical development plans based on strong medical and scientific principals, knowledgeof the regulatory requirements and AbbVie's customers, markets, business operations and emerging issues.

Responsibility may extend from early translational development activities to mature product life cycle management strategies.
Manages the design, conduct and reporting of clinical trials in line with the development, regulatory and commercial strategy
Interacts 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 clinical projects.
Represents AbbVie at external meetings including partnership collaboration meetings, investigator meetings, scientific association meetings, etc.
Dependent on candidate’s therapeutic experience and expertise, the incumbent will be working on RTA408; Melanoma, advanced solid tumors, Friedreich's Ataxia, Mitochondrial, Myopathy or Radiation Dermatitis.

Desired Skills and Experience
Basic:
Medical Doctorate (M.D.) Degree or DO with relevant therapeutic specialty (Immunology, Oncology or Neurology) in the pharmaceutical or bio tech industry.
Minimum of 3 years of clinical trial experience in the pharmaceutical industry
5 years of experience is preferred.
Proven leadership skills in a cross-functional global team environment
Ability to interact externally and internally to support global business strategy
Ability to run a clinical study or development team independently with little supervision
Knowledge of clinical trial methodology, regulatory requirements governing global clinical trials and experience in the design and execution of protocols, and global development programs
This knowledge set is typically associated with a minimum of 3 years of clinical development experience in a pharmaceutical company or Biotechnology company, plus expert knowledge in a relevant therapeutic specialty.
Completion of residency and/or fellowship is strongly preferred.

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