Mythictx
Associate Director, Clinical Operations
Mythictx, Waltham, Massachusetts, United States, 02254
Associate Director, Clinical OperationsCompany 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. 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 role 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.Plan and lead site start-up activities in collaboration with other Clinical Operations colleagues, other Mythic functions, and clinical vendors.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.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.Direct the team and/or participate in study data review and assist 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.Minimum Requirements: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 a 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 skills.Ability to travel up to 20%.Comfortable working with MS Office and project management software (MS Word, Excel, PowerPoint, MS Project, Smartsheet, or similar).Personal Characteristics and Cultural Fit:Good judgement:
Strong problem-solving, critical thinking, and analytical skills required to make evidence-based decisions.Builds Relationships and Culture:
Reputation for creating strong team cultures of quality, trust, and collaboration.Influences:
Highly credible with various stakeholder groups.Execution mindset:
Self-starter with a can-do mindset and do what is needed to advance the company’s programs and initiatives.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.
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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 role 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.Plan and lead site start-up activities in collaboration with other Clinical Operations colleagues, other Mythic functions, and clinical vendors.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.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.Direct the team and/or participate in study data review and assist 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.Minimum Requirements: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 a 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 skills.Ability to travel up to 20%.Comfortable working with MS Office and project management software (MS Word, Excel, PowerPoint, MS Project, Smartsheet, or similar).Personal Characteristics and Cultural Fit:Good judgement:
Strong problem-solving, critical thinking, and analytical skills required to make evidence-based decisions.Builds Relationships and Culture:
Reputation for creating strong team cultures of quality, trust, and collaboration.Influences:
Highly credible with various stakeholder groups.Execution mindset:
Self-starter with a can-do mindset and do what is needed to advance the company’s programs and initiatives.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.
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