| Job Description | We are seeking a Chief Medical Officer (CMO) to lead the Clinical Research organization. This position will work within a multidisciplinary team setting to provide clinical expertise and leadership in support of Clinical Research and the development and commercialization of novel therapeutics in the areas of oncology and autoimmune disease. Major responsibilities will include clinical development strategies, and execution of clinical programs including the strategic planning, implementation, oversight, and completion associated with each clinical research project. Responsibilities will also include leadership and oversight of clinical data management, drug safety, medical monitoring, and medical writing.
Primary Responsibilities:
Leads the development and planning of world-wide clinical trials program.
A key decision maker in determining which company products enter into the clinic setting.
Develops the strategic plans for delivering against key milestones.
Oversees portfolio management activities to ensure appropriate objectives and resources are in place to meet strategic goals and ensure the advance of all of the company’s products in development.
Prepares manuscripts and scientific papers on the Company’s products and clinical findings.
Responsible for representing the company with regulatory and legislative agencies to address the health and medical aspects of our products.
Makes presentations and represents company at various industry or association meetings.
Reports to Chairman of the Board. Will also report to the President and CEO for operational activities and issues.
Required Qualifications:
M.D. with Board Certification in Oncology and/or Rheumatology strongly preferred. If board certified in another field, must have proven track record of involvement in trials that have led to registration/Phase III.
At least 15 years of relevant industry experience in either the pharmaceutical or biotechnology industries. Prior experience in a (global) clinical development and leadership capacity with demonstrated capabilities to lead clinical program(s) to successful filing and approval in both US and global (mainly European) markets.
Strong experience in oncology and autoimmune diseases.
Broad medical, scientific, regulatory, and technical knowledge of most functional areas involved in drug discovery and the development of clinic bound products.
Knowledge of FDA/EMA requirements.
Experience with Phase I – III clinical trials.
Knowledge of GCPs and regulatory (e.g., FDA/EMA) requirements for clinical trials.
Participation in large multi-center and/or global trials, investigational site management, data collection and interpretation, and study protocol compliance.
Ability to work in a collaborative, cross-functional, roll up your sleeves environment. Must be able to develop strong internal and external partnership-type relationships.
Strong analytical and writing skills with record of publications.
Effective management, interpersonal, networking, communication, negotiation, and problem solving skills.
Must be a self-motivated, energetic, approachable and articulate professional with the ability to set goals and deliver against priorities, lead by example, and exhibit creativity while operating from a place of strategic focus. |
| | Company | | Immunomedics, Inc. | Job Code | | State or Province | | New Jersey | | |
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