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

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:

- M.D. and substantial medical/clinical training in Therapeutic Area or a related field.
- Minimum 5-10 years of experience designing, leading and managing significant clinical trials in the Therapeutic Area
- Experience with one or more NDA/MAA submissions is preferred

The Role/Responsibilities:

The Senior Director/ Executive Director, Apremilast Clinical Submission Team will be instrumental in leading the compilation of the clinical sections of the Apremilast Global Registrational Dossier. The incumbent will have hands-on responsibility leading key aspects of the Apremilast clinical submission, reviewing and summarizing data from the three pivotal studies, integrating messages across the pivotal studies and providing significant leadership to the Integrated Summary of Efficacy Team. 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:

- 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, Apremilast Clinical Submission Lead and other team members to prepare abstracts, manuscripts and presentations for external meetings as well as author clinical sections of regulatory documents.
- Assist senior management to oversee quality, coordination and timeliness of clinical sections of 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 multidisciplinary Clinical Study Report Teams.
- Establish and maintain working relationships with Study investigators, key opinion leaders, academicians, and Celgene Senior managers and department heads across the corporation.
- Ensure alignment of registrational dossier with Apremilast Target Product Profile.
- Contribute to Company Core Data Sheet discussions.
- Contribute to Phase IIIb clinical development plans for Apremilast..
- Lead Clinical Study Report Teams jointly with Medical Writing, including interactions with discovery, safety, regulatory, research and other functions.
- 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.
- Provide oversight to contract physicians contributing to the registrational package.
- Manage lifecycle requirements and contribute to plans for designated indications.

Key requirements /knowledge:

- 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.
- Experience with compiling clinical sections of global registrational submissions
- 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 lead cross-functional teams and a true team player
- 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.

News - Celgene Corporation

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