Mythic Therapeutics is a privately held product-platform company that is pioneering a powerful new approach to improving the effectiveness of antibody-drug conjugates (ADCs) and other antibody-based therapeutics. Mythic Therapeutics’ breakthrough Fate Control™ technology dramatically increases the therapeutic potency of ADCs without compromising safety, thereby unlocking the full potential of targeted therapies 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 Associate Director, Clinical Trial Project Management to join our growing clinical team. This person will be responsible for developing and implementing operational strategies, tactics and detailed plans and ensuring the robust execution of clinical studies in accordance with timeline, budget and compliance/data quality goals. The Associate Director, CTPM will be responsible for evaluating and overseeing CRO team(s) and vendors such as central imaging and lab vendors. They will work with a wide array of internal and outsourced development functions including project management, site monitoring, medical writing, biostatistics, data management, clinical supplies, clinical budgeting, and document management. The ability of this person to build strong relationships with investigators, CRO teams and clinical trial sites will be critical to the success of this role. This role will report to the VP, Clinical Research and Operations.
Key Responsibilities and Opportunities:
As a key member of the Clinical Team at Mythic Therapeutics you will:
- Be responsible for developing and implementing operational strategies, tactics and detailed plans and ensuring the robust execution of Mythic’s clinical studies in accordance with established timelines, budgets, and compliance/data quality requirements.
- Advance the use of program management methodologies and metrics to track progress, identify risks, develop risk mitigation strategies through planning, proactive team communication and creative problem solving. To do this, you need to be equally at home explaining your analyses and recommendations to executives as you are discussing the trade-offs in clinical trial execution with our CRO partners and site teams.
- Contribute to authoring/revisions to clinical documents including investigator brochures, protocols, informed consent, safety documents, and clinical study reports as appropriate.
- In partnership with quality assurance partners, develop and maintain process to ensure compliance with GCP requirements and inspection readiness across clinical studies.
- Ability to coordinate site feasibility activities and conduct site feasibility visits as needed and contributes to site selection decisions with senior leadership.
- Effectively interact with key opinion leaders, physician investigators, and site staff.
- Evaluate, determine, and implement the clinical vendor approach for studies as needed; contribute to evaluation and selection of vendors, manage and oversee clinical vendors.
- Ensure effective execution of study plans through the duration of clinical studies.
- Participate in the development of CAPAs to ensure good data quality and oversee implementation of corrective actions.
- Support communication and recommendations of key information to Product Development Team (PDT) to effectively communicate clinical trial plans, needs, and risks and to drive clinical delivery.
- BA/BS in a clinical or scientific discipline,
- 8+ years of clinical operations experience (at least 3-5 with a biotech/pharmaceutical company). Global study experience preferred. Clinical site experience preferred.
- Understanding of FDA, EMEA, ICH and GCP regulations and guidelines.
Personal Characteristics and Cultural Fit:
Communication skills: Able to simplify and convey complex concepts and material, on technical and non-technical levels, both orally and in writing. Excellent listener. Communicate with credibility, confidence, professional maturity and good judgement. Able to clearly and comfortably communicate the strategic and operational results of the team to stakeholders.
Results orientation: A strong individual contributor, with a hands-on style, an obvious sense of urgency, and a strong work ethic. Highly decisive, action-oriented and proactive by nature. Extremely well organized; attention to detail, flexible and responsive to change. Self-starter with a can-do mindset and willingness to do what is needed to advance the company’s clinical programs and initiatives. Demonstrated ability to work in a fast-paced, innovative biotech environment.
Collaboration skills: A superlative team player who works effectively in a team-based environment, readily establishes relationships, seeks input across the organization, achieves credibility with colleagues, builds consensus, and is able to gain alignment around key initiatives.
Strategic capabilities: Able to develop program strategies, based on experience and solid understanding of industry trends. Good business judgment and demonstrated creative problem-solving skills.
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.
“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.”