DirectorSr Director Regulatory CMC

DIRECTOR/SENIOR DIRECTOR OFREGULATORY CHEMISTRY MANUFACTURING AND CONTROLS(CMC)

CompanyOverview:

Mythic Therapeutics is aprivately held clinical stage productplatform company building apipeline of bestinclass antibody drug conjugates (ADCs) exhibitinga combination of unprecedented efficacy and therapeutic index. TheCompanys FateControl engineering technology dramatically enhancesADC uptake in tumor cells with less impact on healthy cells therebysafely increasing efficacy and opening up new therapeuticopportunities against a broad array of tumor targets.

At Mythic Therapeutics we approach our work asentrepreneurs and innovators blazing new trails that lead to betterpatient outcomes. We do so decisively and thoughtfully drawing uponthe decades of experience within our leadership team and scientificadvisers. If you share our passion and sense of urgency fordeveloping effective cancer treatment options and are looking for adynamic collaborative and fulfilling work environment we invite youto explore opportunities to join our team. Together we arereenvisioning cancer therapy.

JobSummary:

Mythic Therapeutics isseeking a Director/Senior Director of RegulatoryChemistry Manufacturing and Controls (CMC) to joinour growing Regulatory Affairs team. This role will report to theVice President Regulatory Affairs and will closely collaborate withTechnical Operations Quality Clinical Operations and otherfunctions to provide direction on the application andinterpretation of global CMC regulations to support the overallproject goals. This individual will also oversee the developmentand execution of regulatory CMC development and registrationstrategies.

As the Regulatory Affairs CMC leadyou will work with Regulatory Technical Operations Quality andClinical project teams as Mythics programs navigate through thedifferent stages of clinical development.

KeyResponsibilities

• Oversee the development and implementation of robust CMCregulatory strategies for all development programs anticipatingphaseappropriate and future commercial requirements in closecollaboration with Technical Operations and Qualitycolleagues.
• Oversee planning preparation andsubmission of highquality regulatory CMC dossiers based on priorknowledge and current environment of the GTx landscape.
• Serve as regulatory voice and provide CMC guidance tointernal teams and lead crossfunctional teams to prepare Module 3and 2.3 sections for INDs and equivalent IMPD sections forCTAs.
• Provide CMC expertise in the Mythicregulatory affairs organization by keeping abreast of global CMCregulatory requirements and ensure that management project teamcolleagues and partners are informed of current regulationregulatory guidance and guidelines and development risks andopportunities that may impact regulatory success for Mythicpipeline products.
• Serve as a Regulatory CMCLead on relevant crossfunctional or functional teams that requireexperienced interpretation of applicable FDA/EMA/ICH/WHO/Globalregulations to ensure CMC compliance.
• Leadteam members to establish CMC content (data and documentation)requirements for regulatory submissions and lead reviews of contentfor conformance with established requirements
• Assess the regulatory impact of proposed manufacturingprocess changes
• Track regulatory CMCcommitments; manage ongoing regulatory submissions and futurereporting requirements including annual reports
• Accountable for the management and delivery of all CMCregulatory milestones such as those related to globalinvestigational drug filings (e.g. IND CTA) registrational filings(e.g. BLA NDS MAA) and responses to health authorityquestions/requests.
• Support Quality and CMCteam during GMP inspections
• Lead CMC relatedinteractions with the health authorities including but not limitedto planning for the related activities managing preparation ofmeeting requests and briefing documents and contingency plans andpreparing responses to preliminary comments.
• Review and approve technical documentation includingtechnology transfer protocols validation protocols technicalreports manufacturing and labeling information to assureconformance with regulations; and regulatory guidelines.
• Represent Regulatory Affairs on CMC due diligence teamsasrequired.

Qualificationsand Experience

• BS/BADegree in a Scientific Discipline Advanced Degree preferred with aminimum of 810 years of demonstrated trackrecord of exceptionalregulatory product development experience.
• Experience in the development of Antibody Drug Conjugates

• This position requires athorough knowledge of CMC related global regulatory guidance andguidelines GMP requirements and an understanding of clinical ICHGood Clinical Practice Guidelines.
• Provenexperience in critically reviewing detailed CMCrelated scientificdata analyses information study reports and documents and providingassessment of technical arguments and conclusions based on the dataand analyses.
• Demonstrated ability to generateinnovative solutions to complex regulatory problems and explaincomplex information in a concise and clear manner.
• Demonstrated track record for successful interactionswith FDA and other global health authorities on CMC topics. Abilityto collaborate and communicate in an open clear complete timely andconsistent manner
• Skilled in planningorganizing prioritizing and leading assigned regulatory activitiesin an efficient and highquality manner.
• Musthave demonstrated experience in preparing and leading CMCdocumentation for regulatory filings (INDs CTAs etc.)

• Able to view issues frommultiple functional perspectives. Ability to work collaborativelyand crossfunctionally with research and development technicaloperations and clinical is critical to success in thisrole.

PersonalCharacteristics and CulturalFit:

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

• BuildsRelationships and Culture: Reputation for creatingstrong team cultures of quality trust and collaboration. Skilled atbuilding and managing relationships crossfunctionally and withexternal collaborators/partners consultants and vendors.

• Influences:Highly credible with various stakeholder group (internal employeesupdown and across the organization external collaborators partnersand vendors and with site teams and investigators). Skilled atbuilding and cultivating stakeholderconfidence.

• Executionmindset: Selfstarter with a cando mindset and dowhat is needed to advance the companys programs and initiatives.Drives self individual and team accountability develops andimplements goals objectives measurable targets and processes toachieve results.

• Demonstratedability to work in a fastpaced innovative biotechenvironment.

Mythic Therapeuticsoffers a fastpaced entrepreneurial teamfocused work environment. Wealso offer a topnotch benefits package and work/life integration.Being part of the Mythic team allows you to become part of a smallteam that supports professional development while working togetherto meet the company goals.

MythicTherapeutics is an equal opportunity employer. We do notdiscriminate on the basis of race color gender gender identitysexual orientation age religion national or ethnic origindisability protected veteran status or any other basis protected byapplicable law. Mythic does not accept unsolicited resumes from anysource other than directly from candidates.