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Vice President, CMC Nuclear Medicine

Posted on Apr 6, 2021 by Clovis Oncology, Inc.

San Francisco, CA 94101
Research
Immediate Start
Annual Salary
Full-Time


The Vice President of CMC Nuclear Medicine reports to the Senior Vice President of Pharmaceutical Development. The VP CMC Nuclear Medicine is a member of the management team and a leading source of scientific and industry expertise in nuclear medicine within the company. The position is responsible for strategic management of contract site activities related to the sourcing of radionuclides, development and manufacturing of nuclear medicine drug products, and development and execution of processes to support clinical studies and commercialization of nuclear medicinal products. The VP CMC Nuclear Medicine will provide input in areas of business development, clinical development and commercialization, financial planning and execution, intellectual property, regulatory interactions, and product quality.


Job Responsibilities


Develops, oversees and directs chemistry, manufacturing and controls (CMC), and supply chain distribution strategies for nuclear medicinal products
Provides guidance and support to internal groups including marketing, commercial, clinical development, clinical operations, and quality
Provides strategic input to regulatory submissions for nuclear medicinal products
Direct interaction with regulatory agencies including FDA, EMA, and NRC
Technical and strategic support for in-license opportunities
Preparation and management of budgets to support product development


Qualifications


Thorough overall understanding of nuclear medicine pharmaceutical development from pre-clinical through post marketing including all stages of development and functional roles
Oncology product development and manufacturing expertise
Deep knowledge of US and international drug and nuclear regulations, CMC development and drug approval processes in relation to nuclear medicinal products
Strong decision making and analytical skills
Excellent communication and influencing skills with the ability to present to a wide range of audiences
Excellent written and verbal communication skills
Excellent leadership and interpersonal skills
Excellent organizational and project management skills, and detail-oriented leadership approach
Ability to work independently on multiple tasks in a fast-paced environment
Proven skills in evaluating, building and motivating teams
Skills in establishing high goals for personal and group accomplishment
Ability to establish and maintain harmonious and productive internal and external working relationships
Ability to work with issue-oriented focus in complex scientific and technical environments
Ability to organize and direct diverse activities in a changing environment often under pressure
High level of integrity and core values consistent with the company's culture and mission
Overall business understanding including experience in business development and licensing products


Education and Experience


Ph.D. in chemistry, pharmaceutical sciences or related field preferred
More than 10 years of direct experience with radiopharmaceutical product development and commercialization
Significant experience contributing to radiopharmaceutical product development and manufacturing from early development through commercialization
A proven track record of driving product development (drug substance and/or drug product) particularly through contract organizations while ensuring materials are provided on time and within budget
Strong record of success in providing astute, strategic leadership in a CMC function
Direct experience with the preparation and review of CMC documentation for regulatory submissions
Experience with establishing clinical and commercial supply chains to support radiopharmaceutical products
Strong technical understanding or nuclear chemistry and radiopharmaceutical products


Compensation


Salary range for this position is $290,000 - $330,000.


Working Conditions


Office-based position with occasional travel both domestic and international.




Reference: 1152693072

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