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Head of Regulatory Affairs and Quality

Location: San Francisco Bay Area

Lassen Therapeutics is a therapeutic antibody discovery and development company dedicated to the identification of novel medicines for serious unmet medical needs.  We are seeking a hands-on Head of Regulatory Affairs and Quality who will bring broad experience in regulatory and operations along with a roll-up-the-sleeves approach to establish and grow an in-house regulatory and quality functions and drive the successful development of an innovative pipeline of fibrosis and oncology therapies.

In this role, you will wear many hats as you establish and operationalize Lassen’s regulatory function. You will have the opportunity to help advance our programs focused on novel antibody-based medicines for therapeutic application in tissue fibrosis, inflammation and oncology. You’re collaborative by nature and are excited about being a key member of a growing team.

Position Summary:

Our ideal candidate will bring a high level of strategic thinking paired wtih a get-things-done attitude, and the ability to apply their experience to manage risk and drive programs forward in a small-company environment. The successful candidate will work with the team in compiling the original submissions of IND and CTA as well as EOP2, response to Health Authority queries as well as oversight of all aspects of regulatory activities. The candidate will also oversee the quality function including working with the company’s GMP consulting firm, GCP consultants and build the quality function over time. The candidate will assure appropriate SOPs are updated and in place for the stage of development of the company.

You will support our clinical programs (Preclinical, Phase 1, 2, 3) and planned future commercial launch. This position will be an integral part of designing and advancing the company’s effort to discover, develop and commercialize our pipeline of therapeutics.

This is a unique opportunity to work with an experienced and well-funded drug discovery and development team in a small company environment.

Responsibilities

  • Develop and implement regulatory strategy across a growing pipeline of early- and mid-stage development programs, with a focus on the successful registration of these products.
    • Enable creative solutions to regulatory challenges to efficiently advance novel therapeutics to key development milestones including positioning for successful pivotal trials and registration.
    • Ensure effective risk management and communication of issues/risks across the portfolio, and participate in driving prioritization of resource and spend.
    • Plan, oversee and participate in all regulatory activities, including regulatory submissions (INDs, NDAs, MAAs, CTAs etc.), preparation and leading of agency meetings.
  • Serve as the company contact with the FDA and other regulatory authorities.
  • Build and lead the Regulatory (Regulatory affairs and operations) function enabling the measured growth and evolution from an outsourced model as the company and our pipeline grows.
    • Optimize CRO interactions and lead external regulatory CROs and vendors to drive excellence and meet phase appropriate regulations and timelines.
    • Develop and manage Regulatory and quality budgets.
    • Develop plans for growth of the regulatory function and hire, manage, and develop Regulatory personnel.
  • Ensure all external data complies with required specifications, standards, protocols, SOPs and overall clinical objectives. Help ensure the continued development, review and updating of SOPs and process documentation in accordance with corporate, industry and regulatory agency standards.
  • Direct and assist internal staff and consultants, to ensure the compliance of R&D activities with U.S. and international requirements.
  • Perform all duties in keeping with the Company’s core values, policies, and all applicable regulations.

Requirements

  • D., PharmD or other relevant post-graduate level training strongly preferred.
  • Minimum of 15 years of industry experience in running multinational and international clinical operations and related activities.
  • Proven track record in building and leading teams in a small company environment.
  • Excellent working knowledge of regulatory regulations and expectations, guidelines, and all phases of clinical drug development.
  • Strong leadership and proven track record in successful implementation and completion of clinical trial programs with adherence to timelines and budgets. Ability to lead under pressure, manage and resolve conflicts and successfully implement new initiatives.
  • Highly motivated, accountable individual with excellent organizational, interpersonal and communication skills and experience working in geographically distributed teams and interacting with all levels of the organization.
  • Excellent knowledge of pharmaceutical business, global drug development and regulatory process.
  • Successful track record of global approvals is preferred. Additional regional experience a plus.
  • Ability to respond to complex operational challenges with innovative solutions supported by appropriate tactics.
  • Proven track record of both strategic and tactical capabilities, demonstrating both the ability to innovate and execute.
  • Strong financial acumen with experience in budgeting models and spreadsheets.
  • Proactive management style, possessing strong motivational and leadership skills.
  • Expert partnering and negotiating skills to support management of our external vendors is required.
  • Additional experience in clinical pharmacology, data management, pharmacovigilance, medical science, or CRO experience is a plus.
  • Position may travel up to 30%.

Lassen Therapeutics offers a competitive benefits package including medical, dental and life insurance benefits for employees and their families.  We also offer a 401(k) plan with a matching contribution and stock options.

We maintain a hybrid work culture.  This position will include onsite/in office work days and up to 30% travel to various site locations as needed. Only local candidates in the San Francisco Bay Area will be considered at this time.

Lassen is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation, veteran status, or any other protected categories.