BioSpace, Inc.
Associate Director, Clinical Operations, Oncology
BioSpace, Inc., Cambridge, Massachusetts, us, 02140
Job Details
The Role:
Moderna is seeking an Associate Director of Clinical Operations to manage studies within the Oncology Therapeutic Area. This may include more than one study. This position will be responsible for initiating and leading clinical trials across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related initiatives. This position reports to the Director, Clinical Operations. This position will work collaboratively across the therapeutic area and cross-functional teams on the overall development programs and related studies to ensure successful execution of assigned projects.
Heres What Youll Do:Accountable for delivery of assigned clinical study budget, timelines, and resource management with focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectivesDevelop operational strategy and clinical operations plans in support of execution of the Clinical Development PlanPartner and collaborate with cross-functional stakeholders such as the Project Leader, Clinical Lead and other relevant stakeholdersLead and oversee execution of first-in-human through phase 4 trials, depending on lifecycle of program, in compliance with ICH/GCP, local regulations, and Moderna SOPsManage invoice and budget tracking for individual studies and provide input into budget forecasting activitiesSupport the selection, oversight, and management of CROs and other vendorsOversee site feasibility/capability assessments in collaboration with the CRO and cross-functional teamReview and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriateManage the cross functional team and CRO/vendor(s) related to all aspects of clinical trial operationsResponsible for representing Clinical Operations on cross-functional project teams and vendor/CRO operational meetings and ensuring compliance with operational standards and proceduresAlong with other Clinical Development personnel, represent Moderna externally to Investigators, site staff, and Key Opinion LeadersPerform and document study level Sponsor Oversight of outsourced clinical activitiesCommunicate study-status, cost and issues to ensure timely decision-making by senior managementManage invoice and budget tracking for individual studies and provide input into monthly and annual forecasting activities for studies and programsOversee/collaborate on and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conductMaintain oversight and participate in the creation/review/training/maintenance of departmental and organizational SOPs to ensure complianceLead and/or participate in clinical operations workstreams related to departmental and operating model related initiativesDevelop and foster strong, collaborative relationships with key stakeholders both within and external to ModernaSupport program level deliverables/activities at the discretion of the Senior Director, Clinical OperationsProvide oversight and mentorship to assigned Clinical Trial Managers and Clinical Trial Associates by providing clinical operations and functional area expertiseStrive for continuous improvement and more efficient ways of working in clinical developmentAct as a role model for Modernas valuesHeres What Youll Bring to the Table:
Minimum of BA/BS with at least 8-10 years of trial and clinical program experience, including at least 4 years of independent clinical trial management experience and full trial life cycle experience (e.g., start-up, conduct, closure). Advanced degree preferred.Robust experience in oncology required. Experience in early clinical development and immuno-oncology desirable. Experience in hematologic malignancies desirable.Multi-dimensional Clinical Operations background with capability of devising plans for operational challenges such as site activation, subject enrollment, monitoring oversight, protocol deviation management, data cleaning, etc.Cross-Collaboration proficiency with other functions such as Regulatory, CMC, Biostatistics, Data Management, Finance, Program Management, etc.Experience in GCP inspections/auditsOutstanding verbal and written communication skills, in addition to excellent organizational skillsProven track record of effective leadership and team-building skills in the context of a multi-disciplinary team in the biotech or pharmaceutical industryResilient, Creative, capable problem-solverExcellent organizational skills and ability to work independentlyExperience in establishing and maintaining relationships with key opinion leadersSome travel requiredModerna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classesExclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:Vacation, sick time and holidaysVolunteer time to participate within your communityDiscretionary year-end shutdownPaid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras!
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our peopleare the driving force behind our scientific progress and our culture.Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. Were focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com . (EEO/AAP Employer)
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The Role:
Moderna is seeking an Associate Director of Clinical Operations to manage studies within the Oncology Therapeutic Area. This may include more than one study. This position will be responsible for initiating and leading clinical trials across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related initiatives. This position reports to the Director, Clinical Operations. This position will work collaboratively across the therapeutic area and cross-functional teams on the overall development programs and related studies to ensure successful execution of assigned projects.
Heres What Youll Do:Accountable for delivery of assigned clinical study budget, timelines, and resource management with focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectivesDevelop operational strategy and clinical operations plans in support of execution of the Clinical Development PlanPartner and collaborate with cross-functional stakeholders such as the Project Leader, Clinical Lead and other relevant stakeholdersLead and oversee execution of first-in-human through phase 4 trials, depending on lifecycle of program, in compliance with ICH/GCP, local regulations, and Moderna SOPsManage invoice and budget tracking for individual studies and provide input into budget forecasting activitiesSupport the selection, oversight, and management of CROs and other vendorsOversee site feasibility/capability assessments in collaboration with the CRO and cross-functional teamReview and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriateManage the cross functional team and CRO/vendor(s) related to all aspects of clinical trial operationsResponsible for representing Clinical Operations on cross-functional project teams and vendor/CRO operational meetings and ensuring compliance with operational standards and proceduresAlong with other Clinical Development personnel, represent Moderna externally to Investigators, site staff, and Key Opinion LeadersPerform and document study level Sponsor Oversight of outsourced clinical activitiesCommunicate study-status, cost and issues to ensure timely decision-making by senior managementManage invoice and budget tracking for individual studies and provide input into monthly and annual forecasting activities for studies and programsOversee/collaborate on and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conductMaintain oversight and participate in the creation/review/training/maintenance of departmental and organizational SOPs to ensure complianceLead and/or participate in clinical operations workstreams related to departmental and operating model related initiativesDevelop and foster strong, collaborative relationships with key stakeholders both within and external to ModernaSupport program level deliverables/activities at the discretion of the Senior Director, Clinical OperationsProvide oversight and mentorship to assigned Clinical Trial Managers and Clinical Trial Associates by providing clinical operations and functional area expertiseStrive for continuous improvement and more efficient ways of working in clinical developmentAct as a role model for Modernas valuesHeres What Youll Bring to the Table:
Minimum of BA/BS with at least 8-10 years of trial and clinical program experience, including at least 4 years of independent clinical trial management experience and full trial life cycle experience (e.g., start-up, conduct, closure). Advanced degree preferred.Robust experience in oncology required. Experience in early clinical development and immuno-oncology desirable. Experience in hematologic malignancies desirable.Multi-dimensional Clinical Operations background with capability of devising plans for operational challenges such as site activation, subject enrollment, monitoring oversight, protocol deviation management, data cleaning, etc.Cross-Collaboration proficiency with other functions such as Regulatory, CMC, Biostatistics, Data Management, Finance, Program Management, etc.Experience in GCP inspections/auditsOutstanding verbal and written communication skills, in addition to excellent organizational skillsProven track record of effective leadership and team-building skills in the context of a multi-disciplinary team in the biotech or pharmaceutical industryResilient, Creative, capable problem-solverExcellent organizational skills and ability to work independentlyExperience in establishing and maintaining relationships with key opinion leadersSome travel requiredModerna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classesExclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:Vacation, sick time and holidaysVolunteer time to participate within your communityDiscretionary year-end shutdownPaid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras!
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our peopleare the driving force behind our scientific progress and our culture.Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. Were focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com . (EEO/AAP Employer)
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