Vice President of Product Development - San Diego, CA | Biospace
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Vice President of Product Development

Cello Therapeutics

Location:
San Diego, CA
Posted Date:
5/26/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:

Job Description

Cello Therapeutics, Inc. is a rapidly growing biotech company located in the Sorrento Valley—one of the major biotech hubs in the nation. Cello focuses on the development of novel nanotherapeutics based on biomimetic cell membrane-coated nanoparticles for cancer treatment. Cello offers a highly motivational and rewarding working environment with attractive salary and benefits. Cello is looking for a VP of Product Development to lead the research and development of the company’s oncology product pipeline and bring a product to market in compliance with global regulatory agencies’ requirements. The VP will work closely with the management and technical teams to ensure successful development of the product pipeline, and will report directly to the CEO. The successful candidate must be able to collaborate effectively and utilize their previous experience and act as a Subject Matter Expert, particularly in the field of oncology. More information about the company can be found at www.cellotherapeutics.com.

Position Responsibilities:
•   Develop company’s oncology portfolio based on the nanotechnology platform through research and understanding of global oncology product market
•   Establish product plan and strategy, lead technical team to develop product roadmap for novel therapeutics
•   Define and monitor key project milestones and critical market assumptions
•   Oversee nanoformulation development, process scale up, and technology transfer from R&D to GMP manufacturing
•   Influence present and future products by determining and evaluating current and future market trends/needs in oncology
•   Maintain research database of relevant clinical oncology trials and therapeutic candidates
•   Enable non-GLP/GLP/GMP production of product
•   Establish cGMP compliant QC labs which includes evaluating and purchasing analytical instruments, and setting up processes for analytical testing and release of raw materials, in-process materials and final drug substance and drug products
•   Ensure product development is in accordance all aspects of global regulatory and quality compliance
•   Assist in regulatory filings of IND/NDA/MAA submissions

Requirements

Position Requirements
•   10+ years of experience in oncological product development
•   4+ years in a leadership position
•   Familiarity with regulatory requirements for IND, NDA/BLA, and MAA submissions
•   Master’s or PhD in engineering (biomedical, chemical, electrical, mechanical) or science (pharmaceutical, chemistry, molecular biology, cell biology, etc.) or an equivalent major
•   Excellent written and oral communication skills
•   Self-motivated creative problem solver that can deal with ambiguity and declare a path forwards to achieve results.
•   Ability to lead in a small, fast-paced, and perpetually evolving environment
•   Strong communication and interpersonal skills

Experience:
•   Prior experience in pharmaceutical product development focusing on sterile parenteral products
•   Working knowledge of global registration requirements and ICH guidelines for drug products including experience with IND, NDA/BLA, MAA submissions
•   Strong knowledge of global regulatory and quality compliance requirements (cGxP)
•   Previous experience working with CDER, OHOP
•   Background knowledge and technical skills in nanotechnology and nanoparticle fabrication and testing is a plus
•   Well-developed interpersonal, organization, and communication skills with the ability to work effectively with staff members at all levels