Clinical Development Manager

2 weeks ago

South San Francisco, United States Neurona Therapeutics Full time
Neurona Therapeutics is a clinical stage biotechnology company based in South San Francisco focused on the development of neuronal cell-based therapies for intractable neurological diseases. Our ideal candidate is a self-motivated individual who has a passion for method development and qualification that can thrive in a fast-paced dynamic environment. The successful candidate will work as a member of the Process Sciences department and will be responsible for projects requiring design and qualification of process equipment. In addition, the candidate will interface with Manufacturing, Process Science, Facilities, Validation, QA, and Contract Engineering/vendor firms to produce detailed designs for procurement, construction, installation, start-up, and validation of process systems including systems for shipping product to clinical sites. This is a fantastic opportunity to join a small team, work on transformative science, and take part in building an exciting, science-driven company.

Key Responsibilities:
  • Leads the development of new methodologies and processes for product delivery to patients.
  • Generates effective hypotheses to pursue project goals; encourages the use of new experimental approaches and/or data analysis methods.
  • Develops novel and creative solutions using their depth of scientific experience to overcome obstacles.
  • Provides input on new device development based on in-field experience and medical literature.
  • Leads validation activities for product development and safety assessments using nonclinical methods.
  • Looks for opportunities for continuous improvement.
  • Supports exploratory biomarker efforts to aid in program development.
  • Uses advanced judgment to balance technical feasibility and impact.
  • Generates external peer-reviewed materials and technical reports for regulatory submissions.
  • Collaborates across many areas of the organization.
  • Manages collaborations and relationships with external partners/vendors.
  • Provides a clinical resource for surgeons, clinicians and others being trained at enrollment sites.
  • Provides leadership, training, and mentorship to other team members.
  • Promotes a positive team culture that focuses on scientific excellence and innovation.
  • Represents Neurona at clinical sites during patient enrollment activities.
  • Assists in evaluation of site qualifications during site recruitment.
  • Demonstrates good follow-through and closure of responsibilities/assignments.
  • Travel to clinical sites is required (approximately 25% effort)

Requirements:
  • Advanced clinical, science or engineering degree (such as MD, DVM, PharmD, PhD, MSN, RN, NP, PA, etc.) with 5+ years relevant experience.
  • Demonstrated mentorship and proven track record in developing team members' professional growth.
  • Excellent written and verbal communication skills.
  • Ability to manage and prioritize multiple projects using strong problem solving skills.
  • Strong team player who uses both internal and external resources to execute activities.
  • Preferred experience: development of medical devices or pharmaceutical equipment for neurological applications; direct experience working in OR or imaging suite; work in the fields of cell or gene therapy

Neurona is proud to be an equal opportunity employer and will consider all qualified applicants for employment.

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