Senior Director, Drug Product Development

Location
San Diego, CA, United States
Posted
Jan 20, 2021
Ref
r4mknH6wQV
Required Education
Doctorate/PHD/MD
Position Type
Full time
Vividion is a privately held biotechnology company based in San Diego that is leveraging an innovative and proprietary chemical proteomics platform to efficiently discover novel drugs in multiple areas including oncology and immunology. We aim to transform the future of human health through the limitless creation of highly selective small molecule medicines that reach unreachable targets. Vividion is looking for energetic and experienced candidates with a desire to work in a fast-paced and dynamic team environment. We believe that the whole team contributes to the overall mission. We succeed as a team, and we grow as a team.

Job Summary:

Reporting to the CSO, the Senior Director, Drug Product Development will be responsible for strategic planning and execution of drug product development and manufacture for all phases of clinical development (research and process validation) The Senior Director provides leadership on all aspects of formulation development and manufacture for development programs. Note: exact title commensurate with experience.

Essential Duties and responsibilities:
  • Design, implement and manage small molecule formulation development, from pre-DC stage through IND filing into early clinical development, in all activities related to formulation and Drug Product
  • Guide research and Design of Experiments to identify formulation and process parameters to meet company deadlines and regulatory filings
  • Effectively lead an internal team of formulation scientists
  • Author appropriate CMC sections to support regulatory submissions (IND, IMPD, NDA)
  • Develop strategic project and resource plans for company drug development programs, and provide high level guidance to senior management on drug product requirements
  • Develop relationships and actively manage external parties (CROs, CDMOs, Raw material suppliers, consultants, etc.)
  • Represent Drug Product Development in a cross-functional manner to communicate resource needs, timelines and critical path activities

Experience and education requirements:
  • Ph.D. with 12+ years industry experience in formulation development in the biotechnology/pharmaceutical industry
  • Extensive formulation and process development expertise,
  • Manufacturing experience and a good understanding of cGMP requirements
  • Skilled in the preparation and review regulatory filings (including INDs, IMPDs, NDAs, briefing packages or other regulatory dossiers) to enable an efficient drug development program

Required Key Attributes:
  • Effective troubleshooting and problem-solving skills
  • Excellent oral and written communication skills
  • Be an effective team player and strong individual contributor, flexible, and able to handle multiple tasks and deliver high quality results under tight timelines

Further Information:

In addition to a competitive compensation package with stock options, Vividion also offers a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, life, disability insurance. Vividion Therapeutics, Inc. is an EEO employer.