Director/Sr. Director, Biomarker and Companion Diagnostics (CDx) Development

Company Overview:

Mythic Therapeutics is a privately held, clinical stage product-platform company building a pipeline of best-in-class antibody drug conjugates (ADCs) exhibiting a combination of unprecedented efficacy and therapeutic index. The Company's 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 re-envisioning cancer therapy.

Job Summary:

Mythic Therapeutics is searching for a dynamic Director/Sr. Director Biomarker and Companion Diagnostics (CDX) Development to join our growing Nonclinical Development team. The Director/Sr. Director will be responsible for leading the development and implementation of biomarker and CDx strategies in support of our innovative ADC programs. This individual will play a crucial role in driving the discovery, selection, validation, and clinical application of biomarker and CDx assays, working closely with cross-functional product development teams to advance our pipeline and deliver breakthrough therapies to patients in need. This person will report directly to the Vice President, Nonclinical Development.

Key Responsibilities and Opportunities:

• Drive the development and implementation of biomarker and CDx strategies for oncology and ADC programs.
• Establish and manage relationships with key external partners, including CROs, consultants, academic institutions, and diagnostic companies.
• Lead the design, validation, and implementation of CDx assays, such as IHC, ELISA, NGS, ctDNA, FISH, and PCR. Provide scientific and technical expertise to guide the discovery, selection, and validation of biomarker and CDx assays.
• Ensure compliance with CDx regulatory guidance and standards, including FDA and EMA requirements. Assist with the preparation and submission of CTA and IVDR applications for CDx assays, and successfully navigate interactions with health authorities to ensure compliance and approval of CDx strategies.
• Oversee the development and execution of biomarker and CDx clinical trials, including protocol design, sample collection, and data analysis.
• Collaborate with cross-functional teams, including Biology, Biologics, Clinical Operations, Clinical Development, and Regulatory Affairs functions, to align biomarker and CDx strategies with overall program objectives.
• Stay current with the latest advancements in biomarker and CDx technologies, incorporating new approaches as appropriate.
  
  

Minimum Requirements:

• Ph.D. and/or MD in a relevant field or specialty, such as molecular biology, genetics, oncology, or pathology, or related degree
• Minimum of 5 years of experience in biomarker and CDx development, with at least 2 years in a leadership role
• Extensive knowledge of CDx assays, including IHC, ELISA, NGS, ctDNA, FISH, and PCR
• Familiarity with CDx regulatory guidance and compliance, including FDA and EMA requirements.
• Proven track record of successful biomarker and CDx development in support of oncology and ADC programs
• Experience working with CROs, consultants, and internal cross-functional product development teams.
• Extensive interaction with healthcare authorities regarding CDx strategies and compliance.
• Strong leadership and communication skills, with the ability to collaborate effectively with cross-functional teams.
• Excellent problem-solving and decision-making abilities
  
  

Preferred Qualifications:

• Experience with CTA and IVDR applications for CDx assays.
• Direct expertise in ADC development and commercialization.
• Familiarity with biomarker and CDx strategies across various stages of the clinical life cycle, from discovery to commercialization.
  
  

Personal Characteristics and Cultural Fit:

• Good judgement: Strong problem solving, critical thinking and analytical skills required to make evidence-based decisions. Good judgment, level-headed, neutral, and objective.
• Builds Relationships and Culture: Reputation for creating strong team cultures of quality, trust, and collaboration. Skilled at building and managing relationships cross-functionally and with external collaborators/partners, consultants, and vendors.
• Influences: Highly credible with various stakeholder groups (internal employees up-down and across the organization, external collaborators, partners, and vendors and with site teams and investigators). Skilled at building and cultivating stakeholder confidence.
• Execution mindset: Self-starter with a can-do mindset and do what is needed to advance the company's 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 fast-paced, innovative biotech environment.
  
  

Mythic Therapeutics offers a fast-paced, entrepreneurial, team-focused work environment. We also offer a top-notch 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.