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Celgene Corporation

Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide.At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our mission as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.There are more than 300 clinical trials at major medical c... Read More

Address      86 Morris Avenue Summit, NJ 07901
Website      www.celgene.com
Holding      No Holding Details

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Clinical RD

Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.

Prerequisites:

- Minimum M.D. or PhD degree and substantial medical/clinical training in Therapeutic Area or a related field.
- Minimum 3-5 years of experience designing, leading and managing significant clinical trials in the Therapeutic Area

The Role/Responsibilities:

The Clinical Development Leader, Therapeutic Area will be instrumental in supporting the growth of the Company's Therapeutic Area infrastructure as the organization continues to build the value of the current products and develop new products. The incumbent will have hands-on responsibility leading the clinical development team, designing and executing clinical trials, and running programs focused on Therapeutic Area, and will exhibit a passion for Phases 1 through 3, including biomarkers, proof-of-concept and full development. This position offers potential growth opportunities to the right candidate possessing a combination of intellectual and execution skills and a love of the science. Representative responsibilities will include:

- Define Target Product Profile and endpoints.
- Plan the overall clinical development of new drug candidates.
- Design and optimize clinical trial design and ensure clinical trials meet ethical and regulatory standards.
- Lead the Clinical Development Team, including interactions with discovery, safety, marketing, regulatory, research and other functions.
- Conduct medical review and interpretation of efficacy and safety data from clinical trials.
- Have responsibility for the quality, coordination, medical accuracy and timeliness of clinical study reports.
- Work with Therapeutic Area Head and other team members to prepare abstracts, manuscripts and presentations for external meetings as well as author clinical sections of regulatory documents (IB, IND sections).
- Assist senior management to oversee quality, coordination and timeliness of clinical sections of INDs, Investigator Brochures, CTAs, ISS’s, ISE’s, and clinical expert reports.
- Present and discuss data and findings at relevant team, governance, KOL and regulatory meetings.
- Participate as clinical representative on multidisciplinaryProject Teams.
- Establish and maintain working relationships with Study investigators, key opinion leaders, academicians, and Celgene Senior managers and department heads across the corporation
- Ensure adherence to GCP/ICH and Celgene Standard Operating Procedure (SOP) standards.
- Maintain clinical and scientific awareness in area of expertise
- Guide day to day work of Clinical Research Scientists.
- Manage lifecycle requirements and plans for designated indications.

Key requirements / knowledge

- Minimum M.D. or PhD degree and substantial medical/clinical training in Therapeutic Area or a related field.
- Minimum 3-5years of experience designing, leading and managing significant clinical trials in the Therapeutic Area
- Direct industry experience is preferred; substantial experience working on industry-sponsored trials will be considered.
- Understanding of drug development process.
- Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements.
- Experience in designing Clinical trial strategies to obtain regulatory approval.
- Ability to provide scientific and clinical expertise to a clinical development program and evaluate scientific and clinical strategies for a product.
- Ability to develop and evaluate strategies for the clinical development of a designated indication and to critically evaluate outside expert advice.
- Experience in Clinical project planning.
- Experience working on global and complex Clinical trials.
- Experience working effectively in a team/matrix environment.

Competencies / skills

- Strong scientific/technical skills
- Strong interpersonal capabilities and ability to build networks
- Proficiency in anticipating and resolving problems
- Excellent managerial and leadership skills
- Excellent verbal communication and technical writing skills
- Ability to present clearly using scientific and clinical terminology
- Ability to lead cross-functional teams and a true team player
- Possesses sense of urgency and can take initiative
- Project management skills and focus on delivery of results
- People management skills
- Ability to motivate

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.

Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.

Other Job Information

Vacancy type:

Full Time

Contact Mode:

not provided

Fax:

not provided

Contact Name:

not provided

Job Duration:

not provided

Phone:

1-908-673-9000

Email:

not provided

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