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Vice President, CMC Management

Neumora

Neumora

Remote
Posted on Wednesday, August 30, 2023

At Neumora, we are pushing the boundaries of science and technology to revolutionize the way patients with brain disease are treated. We are seeking extraordinary individuals to join our team as we grow and advance our pipeline.

Neumora was listed as #1 on BioSpace’s NextGen Bio “Class of 2023,” top life sciences startups to watch!

Reporting to the Chief Technical Operations Officer, the VP, CMC Management is accountable for, and provides leadership to, interdisciplinary, matrix teams responsible for developing and executing compound-specific integrated CMC strategies that drive R&D Project Team objectives and incorporate all elements across the drug substance, drug product, analytical, quality, regulatory, and clinical/commercial supply.

Responsibilities:

  • Leads a team of CMC leaders; builds a strong team of leaders for various assets in development
  • Accountable for managing multiple assets, ranging from development, First-in-Human, and pivotal clinical studies, to intended registrational studies and commercial launch
  • Represents the Tech Ops organization on Program Teams and actively collaborates with other functional areas (Clinical, Commercial, Regulatory, Clinical Pharmacology, Toxicology, etc.) to achieve the best development and business results for the company
  • Leads and manages key strategic vendor interactions for timelines, deliverables and key milestones
  • Communicates and partners effectively with functional areas within Tech Ops and other stakeholders (Quality, Toxicology, DMPK, Clinical Pharmacology, Regulatory CMC, Clin Ops, etc.) to define and execute CMC strategy for the project
  • Identifies and escalates key issues and risks as well as resource allocation needs, as appropriate
  • Critically reviews relevant documents, including but not limited to all CMC regulatory submissions, briefing booklets, information requests, etc.
  • Leads or contributes to continuous improvement initiatives across the enterprise
  • Partners with the Business Development group to support or lead Due Diligence evaluations and activities associated with bringing in new assets and will partner with alliance management, as necessary

Qualifications:

  • Advanced degree in relevant scientific discipline; PhD or MBA preferred
  • At least 15+ years of relevant CMC experience in the pharmaceutical industry; small molecule or experience in multiple modalities is a plus
  • Deep knowledge of IND, IMPD, NDA and EMA submissions; commercial launch experience highly desirable
  • Relevant strategic and tactical project and team leadership experience
  • Broad understanding of analytical, chemical, and formulation development and a proven track record in CMC development for clinical stage programs
  • Solid understanding of how pharmaceutical development integrates and partners with Quality, Regulatory CMC, Non-Clinical, Clinical, and other functional areas
  • Excellent verbal and written communication skills and the ability to effectively work across levels, functions, and with both internal and external stakeholders
  • Strong sense for value of investment, ability to manage ambiguity and make decisions with limited information
  • Embraces Neumora’s shared values and demonstrates passion, innovation, urgency, accountability, inclusion and integrity

Company benefits include:

  • Medical, dental, vision, and life insurance
  • 401k plan: Neumora matches 50% of an employee’s eligible contribution, up to the first 6% of salary (up to 3% employer contribution)
  • New hire stock options
  • Annual paid time off: 15 accrued vacation days, 10 sick days, 12 holidays plus a winter shut-down
  • Leave of Absence: Paid family leave, paid short- and long-term disability
  • Discretionary year-end bonus

The salary range posted describes the minimum to maximum base salary range for this position in the location listed. Actual salary may vary based upon geographic location, work experience, education, licensure requirements and/or skill level and will be finalized at the time of offer. Base Salary Range: $287,000- $300,000

#LI-Hybrid

Neumora Therapeutics is a clinical-stage biopharmaceutical company founded to confront the global brain disease crisis by taking a fundamentally different approach to the way treatments for brain diseases are developed. Our therapeutic pipeline currently consists of multiple clinical and preclinical neuroscience programs that target novel mechanisms of action for a broad range of underserved neuropsychiatric disorders and neurodegenerative diseases. Our work is supported by an integrated suite of translational, clinical, and computational tools to generate insights that can enable precision medicine approaches. Neumora’s mission is to redefine neuroscience drug development by bringing forward the next generation of novel therapies that offer improved treatment outcomes and quality of life for patients suffering from brain diseases.

Neumora is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.