Vice President of Regulatory Affairs

3 weeks ago

California, United States Z-Alpha Therapeutics Full time

Z-Alpha Therapeutics is a pharmaceutical company dedicated to the discovery and development of radiotherapeutics targeting key biological pathways for solid tumors. The company has a revolutionary technology platform in the next generation of alpha particle therapy with potential to be a more targeted therapy, increasing efficacy and limiting toxicity compared to competitors in the radiotherapeutics space. The company has a world-class team of scientists with decades of experience and foundational intellectual property that enables the potential to bring multiple drug candidates into the clinic.

The Role

Reporting into the Chief Executive Officer, the Vice President (VP) of Regulatory Affairs is a critical role needed to provide strategic and operational regulatory oversight over z-alpha’s portfolio. This hire will be responsible for leading the regulatory function of the company and working closely alongside executive leadership. This leader will build strong relationships with regulators and will ensure best practices in regulatory filings and handling of any regulatory requests. This leader will be intimately engaged in shaping the company’s development, filing and commercialization strategy.

This VP will lead development of regulatory strategies through cross-functional teams to ensure expedited and successful advancement of innovative products to approval. This includes timely and transparent communications with regulatory authorities and development partners deep understanding of the regulatory landscape in the development areas, and management of critical regulatory milestones. The work is accomplished in an extremely collaborative manner through development teams and governance on all CMC/Regulatory and Clinical/Regulatory matters. Due to the dynamic of a start-up company, some job responsibilities and duties could change to meet company objectives and strategies.

Specific Responsibilities Include (but are not limited to):

• Define z-alpha’s regulatory strategy for North America

• Oversee the regulatory requirements in the design, implementation and execution of all relevant clinical trials and required NDA-enabling trials.

• Communicating with and presenting to the U.S. (FDA) and Health Canada, and other authorities on all pertinent pharmacovigilance and drug safety issues.

• Interface effectively with relevant functions in the organization to ensure cross-functional compliance for all processes according to international regulations.

• Oversee CMC regulatory strategies for investigational drug products.

• Provide leadership in the requirements and execution of documentation required for compliance.

• As the company grows, leadership and oversight of the regulatory team including any potential consultants.

Candidate Profile

This leader will have experience with development programs through all stages of development including approval and post approval maintenance. They will have hands-on US regulatory submission experience and deep exposure to other regulatory functions such as quality assurance, CMC, product labeling, product development, and promotion. They will have a track record of success in working with FDA and other regulatory agencies throughout their career. This leader will also have regulatory experience dealing with novel modalities and accelerated approval processes.

The ideal candidate is an experienced and nimble professional who thrives in a technically challenging, fast paced and rapidly evolving environment. They will have spent time in start-up organizations and are comfortable in a highly visible role, but capable of rolling up their sleeves and operating in a fast moving and dynamic growth company. They are a proven leader who can simplify complex problems down to solutions with high probabilities of success. This role requires someone with an ability to be inclusive, transparent and open-minded.

Specific qualifications include:

• 15+ years of pharmaceutical and/or biotechnology industry with considerable experience with regulatory affairs experience, particularly in IND filing and Phase 1/2

• Well-developed scientific expertise and a proven track record of successful drug development resulting in North America regulatory approvals.

• Excellent knowledge of current regulatory standards, and expertise in radiotherapeutics and oncology desired.

• A demonstrated ability to effectively interface with the leadership team, investors, and regulatory agencies.

• Leadership experience with a track record of moving products through the approval process, including fast-track designation and priority review applications and approvals.

• Led and worked alongside remote teams and be forward thinking, strategic and decisive in nature.

• Proactive, effective communicator with team, peers and senior leaders, both internally and with external collaborators.

• Prior experience building, staffing and leading an emerging biopharmaceutical company. Knowledge of how people/organizations work and ability to apply that knowledge to influence, lead change, deliver strong results and build the confidence of stakeholders.

• High ethical standards, integrity and strength of character in his/her personal and professional dealings and a willingness to act on and be accountable for his/her decisions.

In terms of the performance and personal competencies required for the position, we would highlight the following:

Setting Strategy

• The inclination to seek and analyze data from a variety of sources to support decisions and to align others with the organization's overall strategy.

• An entrepreneurial and creative approach to developing new, innovative ideas that will stretch the organization and push the boundaries within the industry.

Executing for Results

• Comfortable with ambiguity and uncertainty; the ability to adapt nimbly and lead others through complex situations.

• A risk-taker who seeks data and input from others to foresee possible threats or unintended circumstances from decisions; someone who takes smart risks.

• A leader who is viewed by others as having a high degree of integrity and forethought in their approach to making decisions; the ability to act in a transparent and consistent manner while always taking into account what is best for the organization.

Relationships and Influence

• Naturally connects and builds strong relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively.

• An ability to inspire trust and followership in others through compelling influence, powerful charisma, passion in their beliefs, and active drive.

• Creates a sense of purpose/meaning for the team that generates followership beyond their own personality and engages others to the greater purpose for the organization as a whole.

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