Other Locations:US- NJ- Summit East
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Director, Medical Affairs, Rheumatology
The Director will provide scientific and medical support for the Rheumatology therapeutic area, informing key I&I imperatives. He/she will be responsible for overseeing parts or the totality of clinical phase IV studies, together with a cross-functional team. In addition, he/she will be responsible/contribute to the development of the Global and US Medical Affairs strategic and tactical plans, as well as executing against the medical plans. He/she will work closely with a cross-functional group that includes Clinical Development, Corporate Medical Affairs, HEOR/Market Access, Marketing and Regulatory. This person must have the ability to work effectively in a highly matrixed environment and have a successful track record of leading various Medical Affairs activities, including clinical study activities. He/she is expected to have a strong commitment to achieving medical objectives while maintaining the highest ethical, regulatory and scientific standards.
Responsibilities will include, but are not limited to, the following:
- Provides expert opinion on the current trends in the pathophysiology, diagnosis, existing and emerging treatment options as well as unmet medical needs in the therapeutic area in order to inform key medical and business decisions.
- Contribute to Global/US Rheumatology Phase 4 development plan and serve as a study lead and medical monitor for a global Phase 4 study
- Contribute to and lead the development and execution of the US and Global strategic and tactical Medical Affairs plans, which support I&I imperatives.
- Support the development of Study Protocols, Life Cycle Management Plans and other key study documents in conjunction with other line functions and with limited guidance.
- Responsible for medical interpretation of data (clinical trials, registries, published literature, etc.) for in-development and /or marketed compounds and assure training of Affiliates Medical Affairs teams.
- Participate in formal scientific review of submitted Investigator Initiated Trials and related medical affairs activities (e.g. registry/database projects, epidemiological surveys etc.). Provide timely and interactive feedback to achieve optimal study designs and to ensure adequate study progress.
- Develop strong relationships with key opinion leaders, key professional societies and organizations, with a special focus on US.
- Lead and Participate in US/Global Advisory Board meetings with opinion leaders.
- Participate in and support the Global Publication Plan.
- Actively participate on US/Global promotional review committees to ensure content is medically appropriate and compliant with internal and external requirements.
- M.D., D.O., PhD or equivalent degree , preferably with experience in the areas of Rheumatology
- US Board Certified Rheumatologist preferred or strong international or regional experience.
- Director (7-10 years) / Sr. Director (11+ years) in the pharma/biopharma industry and a minimum 3 years of experience in the therapeutic area is required.
- Experience with global clinical study activities, study director leadership experiences preferable
- Excellent written and oral communication skills, including strong formal presentation skills.
- Excellent planning and organization skills.
- Strong interpersonal skills commensurate with the need to work closely with both external physicians/scientists and numerous in-house support groups.
- Ability to maintain the highest degree of confidentiality and integrity, represent the company’s high ethics, moral behavior, and professionalism.
- Ability to work under pressure, and to maintain scientific excellence within timelines
- Demonstrated ability to maintain scientific credibility while executing the Medical Affairs plan, and to communicate scientific results and effectively respond to data queries from customers and/or consultants.
- Strong scientific analytical skills
- Knowledge of scientific methods, research design and medical practices and procedures that would be acquired through research, clinical experience or clinical research studies
- Basic knowledge and appropriate application of biostatistics
- Ability to travel (frequent travel will be required)
- Proficient in Microsoft Office applications including Word, Power Point and Outlook
- Travel as required
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.