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Sr. Director/VP, Regulatory Affairs

Atomwise

Atomwise

Legal
San Francisco Bay Area, CA, USA · San Francisco, CA, USA · San Diego, CA, USA
Posted on Thursday, October 26, 2023

Atomwise is a technology-enabled pharmaceutical company leveraging the power of AI to revolutionize small molecule drug discovery. The Atomwise team invented the use of deep learning for structure-based drug design; this technology underpins Atomwise’s best-in-class AI discovery engine, which is differentiated by its ability to find and optimize novel chemical matter.

Atomwise has extensively validated its discovery engine, delivering hit ID success in over 200 academic and collaboration projects-to-date including a wide-variety of protein types and numerous “hard-to-drug” targets. Atomwise is building a wholly-owned pipeline of small-molecule drug candidates, with two programs in lead-optimization and programs in immunology and oncology in the discovery stage.

The company has raised over $174 million from leading venture capital firms to advance its mission to make better medicines, faster.

About the role

The Vice President, Regulatory Affairs provides strategic leadership and oversight to multiple global regulatory projects. This individual will be responsible for developing and directing regulatory strategy, objectives, policies and programs for cutting-edge Immunology and Oncology drug development programs. This is a critical leadership role within the company and has significant influence on the achievement of corporate goals, objectives and key results.

Key Responsibilities

  • Lead the creation, evaluation, and recommendation of regulatory strategies and tactics to support the achievement of clinical program goals.
  • Working with the cross-functional development team, they will lead Health Authority meetings associated with the program, hold accountability for the program’s global regulatory plan and its execution, identify and assess regulatory risks associated with planned clinical development activities, and provide technical advice and counsel.
  • Lead the global regulatory strategy for the assigned product(s), accountability for ensuring that plans meet global regulatory requirements.
  • Review and approve all submission documents, including clinical study protocols and reports, statistical analysis plans, investigator brochures, development safety update reports, and other documents as needed.
  • Support strategy for providing submission of CMC and non-clinical information.
  • Act as the independent subject matter expert in giving guidance to project teams, departments, and management, while considering companywide implications
  • Contribute to the development of target product profile and draft labeling.
  • Lead marketing application submission team(s).
  • Lead the development of strategic plans and oversee execution of the creation and submission of regulatory documents, e.g., INDs, NDAs, CTAs, MAAs, and other relevant regulatory filings, ensuring compliance with all applicable regulations.
  • Oversee the planning and implementation of meetings with regulatory agencies and effectively represent the company at agency meetings.
  • Identify and recommend plans incorporating strategies designed to utilize efficient regulatory pathways and to maximize chances of successful submissions.
  • Critically direct regulatory documents to ensure that they are complete, well organized, scientifically accurate, of high-quality, in compliance with agency requirements, and written to streamline agency review to accomplish company goals and objectives.
  • Monitor current and proposed regulatory issues and trends and advise management on events of significance with respect to business interests.
  • Identify and implement processes, procedures, and solutions for regulatory optimization and efficiency.
  • Provide Regulatory assessment to matrixed program teams in terms of risks, requirements, and opportunities associated with assets in development.
  • Provide Regulatory assessment to due diligence teams in terms of risks, requirements, and opportunities associated with potential in- or out-licensing.
  • Build partnerships with vendors, licensors and development collaborators, aligning on regulatory strategies, deliverables, and goals.
  • Set a compelling vision to motivate and inspire cross-functional teams and external partners to work effectively and within agency requirements.

Required Qualifications

  • 15+ years of industry experience with a minimum of 10+ years in progressive regulatory leadership roles.
  • Experience and expertise in developing regulatory strategies leading to significant clinical development progression.
  • Demonstrated success in working in a cross-matrixed, collaborating with groups including clinical development, clinical operations, clinical pharmacology, commercial, technical operations, pharmacology/toxicology, and medical affairs.
  • Significant experience with US FDA regulations; strong understanding of Global Health Authority policies, laws, regulations, and guidelines for global drug development and approvals.
  • Significant knowledge of the drug development process (early stage through commercialization).
  • Deep knowledge of health authority requirements/guidelines, including ICH.
  • Ability to lead and oversee work of CMC regulatory team to ensure successful CMC submissions.
  • Demonstrated ability to coordinate global activities, drive quality decision-making, organize/prioritize tasks, negotiate with and influence others, and facilitate issue resolution and conflict management.
  • Demonstrated ability to prepare for launch readiness.
  • Effective communication skills that allow for teamwork, collaboration, and open dialogue cross-functionally (verbal/written/email/presentation) is required.
  • The need to speak with ease, confidence, and ability to come well-prepared and solution-focused with all levels of the leadership team.
  • Ability to communicate regulatory strategy to key stakeholders at all levels of the organization is vital to the success of the role.
  • Significant experience with identification and management of external resources.
  • Excellent communication and computer skills.
  • Ability to travel as needed (US and International).

Preferred Qualifications

  • Regulatory experience with small molecule drugs in Immunology and Oncology indications.

Compensation & Benefits

  • Competitive salary, commensurate with experience
  • Stock compensation plan – you’ll be an Atomwise co-owner
  • Platinum health, dental, and vision benefits for you and your dependents
  • 401(k) retirement plan with generous company match (up to 4%)
  • Flexible paid time off (PTO), 13 paid holidays, and wellness breaks for employees to spend time with their loved ones and recharge
  • Health Savings and Flexible Spending Account options to help save money on healthcare, daycare, and commuting
  • Employee Assistance Program (EAP) and Pet Insurance
  • Funding for professional development and conference attendance
  • Flexible work schedule
  • Generous paid parental leave

Atomwise is an equal opportunity employer and strives to foster an inclusive workplace. Our mission is to develop better medicines faster, and we know that we need a diverse team to develop medicines that serve diverse populations. Accordingly, Atomwise does not make any employment decisions (including but not limited to, hiring, compensation, and promotions) on the basis of race, religion, color, national origin, gender, gender identity, sexual orientation, age, veteran status, disability status, or any other characteristics protected by applicable federal, state, and local law.

We strongly encourage people of diverse backgrounds and perspectives to apply.

*Pay range for this role is between $290,000 - $322,000*