Corporate Vice President, Clinical Research and Development - Therapeutic Area Head Myeloid Diseases - Summit, NJ | Biospace
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Corporate Vice President, Clinical Research and Development - Therapeutic Area Head Myeloid Diseases

Celgene

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Location:
Summit, NJ
Posted Date:
5/25/2017
Position Type:
Full time
Job Code:
16001074
Salary:
Required Education:
Medical Doctor
Areas of Expertise Desired:

Job Description


Description

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.

SUMMARY:

Reporting into the Senior Vice President for Global Clinical Development, the VP or Corporate Vice President will be the Therapeutic Area Head for all MDS/AML/beta-Thalassemia programs. The VP or Corporate Vice President of Global Clinical Development is responsible for worldwide clinical development. Will be responsible for the development of all compounds from proof of principle through registration globally. These responsibilities will include:


•  Strategy for the clinical development of medicines
•  Integration and incorporation of all early clinical development work including biomarkers and companion diagnostics
•  Timelines and budget for clinical development of medicines
•  Design and conduct of all clinical trials of medicines globally (including Asia and Japan)
•  Alignment with Regulatory Affairs, Global Project Leadership, Research & Early Development/translational medicine as well as Market Access, Medical Affairs and commercial functions.

RESPONSIBILITIES:

The VP or Corporate Vice President will lead or participate in and have critical input into leading, overseeing and partnering on all of the clinical elements of development for multiple medical/clinical programs around the world. He/she
will be responsible for driving the implementation of the overall medical/clinical strategic direction for the MDS/AML team. The major responsibilities of the VP or Corporate Vice President will be to:

•  Lead the CR&D Therapeutic Area team, attract, retain and develop talent for all roles in the team, be responsible for engagement and collaboration across the team
•  Drive indication and product strategic vision through strong scientific and medical knowledge, exceptional understanding of the drug development process and a strong ability to contribute/lead cross-functional teams.
•  Active membership of the cross-functional Oncology Leadership Meeting (OLM) and the department-internal CR&D Leadership Team
•  Active membership and functional leadership in the cross-functional Disease Strategy Team for MDS/AML, ability to lead such a team
•  Incorporate a sound business sense into the clinical development program
•  Very close collaboration and partnership with Regulatory Affairs to drive clinical strategic objectives, submissions and approvals
•  Medical/clinical review on due diligence and in-licensing opportunities
•  Build efficiency and innovation into the clinical development program and look for innovative ways to do clinical trials - like biomarker strategy
•  Understand how all clinical development groups work together and how it all funnels into clinical data flow.
•  Take a role within the global CR&D leadership team in order to advance the work of the whole department
•  Organize and lead advisory boards and investigator meetings relevant to clinical projects with the respective teams in the therapeutic area.
•  Responsible as a thought leader in the development of new and innovative strategies related to regulatory and clinical use of new and existent pharmaceuticals
•  Responsible for clinical budget allocations, capacity planning and responsibility for utilization reporting and budget review and tracking
•  Develop strong and reliable relationship to Celgene's partners in the joint development of medicines for this therapeutic area.

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.

*LI-PM1

Requirements

Qualifications
PREREQUISITES:

Physician (MD or equivalent) with 10-15 years of pharma or biotech experience in Hematology or Oncology

SKILLS:

The VP or CVP must be a physician (MD or equivalent, academic experience/credentials a plus but not essential) with 10-15 years of pharma or biotech experience in Hematology or Oncology as well as sufficient clinical experience in the treatment of MDS and AML (preferably) or other hematological malignancies in Celgene's portfolio (esp. multiple myeloma or lymphoma).

In addition, the ideal candidate would have:

•  A solid background in all phases of clinical development which includes:
    o  Development of clinical development strategy incorporating innovative endpoints, biomarkers, structured decision-making and analysis of the competitive landscape
    o  Clear track record of successful execution of clinical trials from Phase I through Phase III; (Phase IV a plus)
    o  Clinical elements of IMPD or IND submission
    o  Maintenance of clinical program budgets and timeline
    o  Interpretation, summarization and presentation of scientific data in industry, academic and regulatory settings
    o  Assistance in the preparation of study reports, investigator brochures and scientific publications
    o  Sound basis of medical knowledge, clinical experience, statistics and pharmaco-economics