DirectorSr Director Regulatory CMC

DIRECTOR/SENIOR DIRECTOR OF REGULATORY CHEMISTRY MANUFACTURING AND CONTROLS (CMC)

Company Overview:

Mythic Therapeutics is a privately held clinical stage productplatform company building a pipeline of bestinclass antibody drug conjugates (ADCs) exhibiting a combination of unprecedented efficacy and therapeutic index. The Companys FateControl engineering technology dramatically enhances ADC uptake in tumor cells with less impact on healthy cells thereby safely increasing efficacy and opening up new therapeutic opportunities against a broad array of tumor targets.

At Mythic Therapeutics we approach our work as entrepreneurs and innovators blazing new trails that lead to better patient outcomes. We do so decisively and thoughtfully drawing upon the decades of experience within our leadership team and scientific advisers. If you share our passion and sense of urgency for developing effective cancer treatment options and are looking for a dynamic collaborative and fulfilling work environment we invite you to explore opportunities to join our team. Together we are reenvisioning cancer therapy.

Job Summary:

Mythic Therapeutics is seeking a Director/Senior Director of Regulatory Chemistry Manufacturing and Controls (CMC) to join our growing Regulatory Affairs team. This role will report to the Vice President Regulatory Affairs and will closely collaborate with Technical Operations Quality Clinical Operations and other functions to provide direction on the application and interpretation of global CMC regulations to support the overall project goals. This individual will also oversee the development and execution of regulatory CMC development and registration strategies.

As the Regulatory Affairs CMC lead you will work with Regulatory Technical Operations Quality and Clinical project teams as Mythics programs navigate through the different stages of clinical development.

Key Responsibilities

• Oversee the development and implementation of robust CMC regulatory strategies for all development programs anticipating phaseappropriate and future commercial requirements in close collaboration with Technical Operations and Quality colleagues.
• Oversee planning preparation and submission of highquality regulatory CMC dossiers based on prior knowledge and current environment of the GTx landscape.
• Serve as regulatory voice and provide CMC guidance to internal teams and lead crossfunctional teams to prepare Module 3 and 2.3 sections for INDs and equivalent IMPD sections for CTAs.
• Provide CMC expertise in the Mythic regulatory affairs organization by keeping abreast of global CMC regulatory requirements and ensure that management project team colleagues and partners are informed of current regulation regulatory guidance and guidelines and development risks and opportunities that may impact regulatory success for Mythic pipeline products.
• Serve as a Regulatory CMC Lead on relevant crossfunctional or functional teams that require experienced interpretation of applicable FDA/EMA/ICH/WHO/Global regulations to ensure CMC compliance.
• Lead team members to establish CMC content (data and documentation) requirements for regulatory submissions and lead reviews of content for conformance with established requirements
• Assess the regulatory impact of proposed manufacturing process changes
• Track regulatory CMC commitments; manage ongoing regulatory submissions and future reporting requirements including annual reports
• Accountable for the management and delivery of all CMC regulatory milestones such as those related to global investigational drug filings (e.g. IND CTA) registrational filings (e.g. BLA NDS MAA) and responses to health authority questions/requests.
• Support Quality and CMC team during GMP inspections
• Lead CMC related interactions with the health authorities including but not limited to planning for the related activities managing preparation of meeting requests and briefing documents and contingency plans and preparing responses to preliminary comments.
• Review and approve technical documentation including technology transfer protocols validation protocols technical reports manufacturing and labeling information to assure conformance with regulations; and regulatory guidelines.
• Represent Regulatory Affairs on CMC due diligence teams as required.

Qualifications and Experience

• BS/BA Degree in a Scientific Discipline Advanced Degree preferred with a minimum of 810 years of demonstrated trackrecord of exceptional regulatory product development experience.
• Experience in the development of Antibody Drug Conjugates

• This position requires a thorough knowledge of CMC related global regulatory guidance and guidelines GMP requirements and an understanding of clinical ICH Good Clinical Practice Guidelines.
• Proven experience in critically reviewing detailed CMCrelated scientific data analyses information study reports and documents and providing assessment of technical arguments and conclusions based on the data and analyses.
• Demonstrated ability to generate innovative solutions to complex regulatory problems and explain complex information in a concise and clear manner.
• Demonstrated track record for successful interactions with FDA and other global health authorities on CMC topics. Ability to collaborate and communicate in an open clear complete timely and consistent manner
• Skilled in planning organizing prioritizing and leading assigned regulatory activities in an efficient and highquality manner.
• Must have demonstrated experience in preparing and leading CMC documentation for regulatory filings (INDs CTAs etc.)

• Able to view issues from multiple functional perspectives. Ability to work collaboratively and crossfunctionally with research and development technical operations and clinical is critical to success in this role.

Personal Characteristics and Cultural Fit:

• Good judgement: Strong problem solving critical thinking and analytical skills required to make evidencebased decisions. Good judgment levelheaded neutral and objective.

• Builds Relationships and Culture: Reputation for creating strong team cultures of quality trust and collaboration. Skilled at building and managing relationships crossfunctionally and with external collaborators/partners consultants and vendors.

• Influences: Highly credible with various stakeholder group (internal employees updown and across the organization external collaborators partners and vendors and with site teams and investigators). Skilled at building and cultivating stakeholder confidence.

• Execution mindset: Selfstarter with a cando mindset and do what is needed to advance the companys programs and initiatives. Drives self individual and team accountability develops and implements goals objectives measurable targets and processes to achieve results.

• Demonstrated ability to work in a fastpaced innovative biotech environment.

Mythic Therapeutics offers a fastpaced entrepreneurial teamfocused work environment. We also offer a topnotch benefits package and work/life integration. Being part of the Mythic team allows you to become part of a small team that supports professional development while working together to meet the company goals.

Mythic Therapeutics is an equal opportunity employer. We do not discriminate on the basis of race color gender gender identity sexual orientation age religion national or ethnic origin disability protected veteran status or any other basis protected by applicable law. Mythic does not accept unsolicited resumes from any source other than directly from candidates.