Associate Director, Clinical Operations
3 days ago
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 Associate Director (AD), Clinical Operations to join our growing Clinical Development team. This person will be responsible for developing and implementing operational strategies, tactics and detailed plans and ensuring the robust execution of Global clinical studies in accordance with timeline, budget and compliance/data quality goals. The Associate Director 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, finance, 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 roles reports to the Vice President, Clinical Operations.
Key Responsibilities and Opportunities:
- Independently lead and coordinate all aspects of study operations for Phase 1-3 studies or programs, including large, global, complex study(ies).
- Advance the use of study/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 internal team, CRO partners and study site staff.
- Plan and lead site start-up activities in collaboration with other Clinical Operations colleagues, other Mythic functions, and clinical vendors including, but not limited to, facilitating site engagement and recruitment activities and site training and communications.
- Create and implement effective patient enrollment strategies with input and approval from key stakeholders.
- Lead assigned studies within agreed timelines and budget and in accordance with SOPs, ICH/GCP guidelines, and all applicable laws and regulations.
- Lead a cross-functional team in the development and writing of study protocols, plans, CRF’s, informed consent forms, study reports, sections for Investigator’s Brochures, and regulatory documents.
- Function as the primary liaison between clinical vendors and Mythic to ensure understanding of expectations and scope of work and agreed upon timelines/budgets established for the study(ies) are being adhered to.
- Communicate with the cross-functional study team, the management team, and clinical vendors concerning status and progress of the trial. (Including but not limited to: milestones, timelines, budget, risks).
- Coordinate study team training and quality checks to ensure cross-functional study team members and CRO/vendor staff are compliant with use of required systems e.g. eTMF, EDC, IRT, study team SharePoint, and others as required
- Directs the team and/or participates in study data review and assists with site management to ensure data quality and timely data entry
- Build and maintain solid professional relationships with the internal team, CROs/vendors, investigators, and clinical study site staff
- Participate in SOP, work instruction and template development and improvement initiatives
- May be required to perform line management duties
- Bachelor’s degree in life sciences or equivalent training required
- Minimum of six (6+) years of experience in clinical study management in a CRO or bio-pharma setting, with minimum of four (4+) years as a Clinical Trial/Project Manager leading the management of global clinical studies and cross-functional teams
- Minimum of four (4+) years of experience in managing clinical trial vendors (e.g. CRO, Central Laboratories)
- Experience managing Global Phase 1-3 Oncology Clinical Trials is preferred
- In-depth experience with all site start-up activities including strong working knowledge of site start-up documents
- Understanding of FDA, EMEA, ICH, and GCP regulations and guidelines
- Exceptional organizational skills and ability to deal with competing priorities
- Excellent verbal and written communication
- Ability to travel up to 20%
- Comfortable working with MS Office and project management software (MS Word, Excel, PowerPoint, MS Project, Smartsheet, or similar)
- 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 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.
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