Waltham, MA, USA
Posted on Friday, July 14, 2023
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 tumor uptake of ADC per dose, thereby safely increasing potency 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 seeking an experienced VP, Preclinical to lead the development and execution of the company’s toxicology, biomarker, and bioanalytical efforts for our ADC candidates. You will provide leadership for the preclinical development of ADC development candidates from lead identification through health authority marketing application and approval. You will have excellent organizational and oral/written communication and presentation skills, and the ability to strategically plan and foresee potential problems while developing solutions. Must have the ability to lead multiple projects simultaneously on tight timelines and shift priorities quickly when needed.The VP, Preclinical will play a central role in Mythic’s preclinical strategy and have an outsized impact on our pipeline of ADC programs as they begin clinical studies. You will oversee multiple key functional areas and represent the company to external stakeholders such as clinical investigators and KOLs, pharma partners, and health authorities. You will lead and work cross-functionally within product development teams, including representing the entire research team and collaborating/transitioning key workstreams to clinical pharmacology, clinical operations, data management, CMC, and medical monitoring.The successful candidate will be a hands-on leader with proven Preclinical experience in oncology development and possesses a “can-do”, execution-oriented mindset. Experience in the field of ADC development is a plus. Key Responsibilities and Opportunities:As a key member of the R&D Team at Mythic Therapeutics you will:
- Design preclinical development strategies for candidate ADCs, including toxicology, biomarker, and bioanalytical strategies
- Support the design of toxicology studies and identify appropriate external vendors for execution of studies
- Oversee preclinical safety and translational studies to support IND filing and clinical development
- Coordinate the integration of bioanalysis, biomarker, and toxicokinetic aspects into these studies to ensure on-time delivery of key data and study reports
- Oversee development at external vendors of IHC-based biomarkers to key validation milestones (e.g., RPA, CTA)
- Lead and manage the established preclinical team and vendors specializing in toxicology, biomarkers, and bioanalytical to drive all aspects of pre-IND and early-stage clinical development initiatives for the company
- Partner with an extensive team of external expert consultants to drive development programs forward
- Work with program teams to help interpret and integrate results of animal models of disease for eﬃcacy/tolerability assessment and PK/PD evaluation
- Provide guidance to and communicate with Mythic Team on key conclusions and potential impact of results on program and clinical/regulatory strategy in a transparent and timely manner
- Lead the development of early hypothesis-driven investigation into mechanisms of toxicity for the proactive management of potential safety liabilities
- PhD or DVM with a minimum of 10 years of relevant industry experience with a demonstrated track-record of exceptional leadership within the life sciences industry
- Deep expertise in one of: development of biomarkers through CTA validation OR IND-enabling toxicology of ADC, antibody or protein-based biologics is required
- Proven ability to design, manage and interpret outsourced preclinical safety studies and/or work with external partners to develop biomarkers for use in clinical trials
- Previous experience progressing preclinical biologics development candidates through IND filing and into clinical development; NDA/BLA experience highly desirable
- Experience interacting with worldwide regulatory agencies, including authoring of IND and NDA/BLA sections
- Comprehensive understanding of the interplay between preclinical safety, pharmacology, biomarkers, PK and CMC. Experience with PK modeling is a plus.
- Strong working knowledge of bioanalytic techniques and assays required to meet health authority requirements for GLP studies of antibodies and small molecule therapeutics
- Extensive experience managing CRO partners and proven ability to work in a hybrid outsourced model
- Working knowledge of GLP compliance and relevant ICH & FDA guidance documents
- Excellent written and oral communication skills and the ability to effectively communicate with internal and external team members on project activities
- Strong problem solving, critical thinking and analytical skills, required to make sound decisions; ability to prioritize and adapt quickly to changing environments and priorities
- 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 group (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.