Sr. Clinical Scientist/Clinical Scientist
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.
Mythic Therapeutics is searching for a dynamic Sr. Clinical Scientist/Clinical Scientist to join our growing Clinical Development team. The Sr. Clinical Scientist/Clinical Scientist will be responsible for supporting the advancement of our lead ADC program MYTX-011 through key development milestones and will have the opportunity to work on both early and late-phase clinical trials. Specifically, this person will contribute to the review and interpretation of data, drafting of study documents, and development and execution of the study strategy. Strong communication skills and the ability to work in a fast-paced, matrix environment will be critical to the success of this role, as the Sr. Clinical Scientist/Clinical Scientist will work closely with a range of internal functions (Clinical Operations, Regulatory, Data Management, CMC, Quality) and external partners (CRO, study sites, consultants).
This position will report directly to the Sr. Medical Director.
Key Responsibilities and Opportunities:
- Support the Sr. Medical Director and cross-functional study/product development team in the oversight of clinical studies including data review and interpretation of clinical trial data and timely execution of deliverables in collaboration with relevant internal and external partners.
- Draft and review study documents including study protocols, informed consents, Investigator Brochure, Clinical Study Reports (CSRs), and other study-related documents for the execution of clinical studies.
- Drive safety review committee, investigator calls, and other important clinical update meetings, including generating meeting materials and presenting study findings.
- Lead study site communication together with the CRO, respond to queries, and support safety reporting process/documentation.
- Participate and present in investigator meetings, training sessions, and investigator/study site staff engagement.
- Assist in the preparation of abstracts, poster presentations, and manuscripts of clinical study findings.
- Support Regulatory activities (e.g., IND, BLA/NDA, meetings with healthcare authorities) as required.
- Prepare materials for key clinical external and internal meetings.
- Conduct literature reviews pertaining to the strategy and execution of the clinical study.
- Bachelors in a scientific related area (pharmacy, nursing, biology) required. Advanced degrees in life science are preferred (PhD, PharmD, MD, MPH, MS).
- A minimum of 3 years of Oncology clinical research and development (or related) experience in the Biotechnology, CRO, or Pharmaceutical Industry or 5 years of direct clinical trial experience at a clinical study site is required.
- Experience in clinical data review.
- Experience in writing and reviewing clinical documents (protocols, CSRs, IBs, etc). Healthcare authority submission experience (IND, BLA/NDA) is preferred.
- Proficient in Medical Terminology and Medical writing skills.
- Thorough understanding of FDA, GCP, and ICH guidelines.
- Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities.
- Excellent team player; willingness and ability to fill functional gaps in a small, fast-growing organization.
- Ability to travel (including international travel) up to 10% required.
- ADC or Biologics experience preferred
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 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.
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, protectedveteran status or any other basis protected by applicable law. Mythic does not accept unsolicited resumes from any source other than directly from candidates. Candidates will be required to show proof of being fully vaccinated against COVID-19 upon commencing employment. Reasonable accommodations will be considered on a case-by-case basis for exemptions to this requirement in accordance with applicable law.