BioSpace
Associate Director, Clinical Operations, Therapeutics
BioSpace, Cambridge, Massachusetts, us, 02140
Overview
Associate Director, Clinical Operations, Therapeutics. Moderna is seeking an Associate Director, Clinical Operations to manage studies within the Clinical Operations, Therapeutics and Oncology Therapeutic Area. The role will initiate and lead clinical trials across all phases, oversee CROs and vendors, and work cross-functionally on clinical operations strategy and related initiatives. The position will focus on ongoing studies in metabolic rare diseases, with future support for oncology.
Responsibilities
Accountable for delivery of assigned clinical study budget, timelines, and resource management with a focus on quality; make recommendations and decisions regarding operational strategies to support study and/or program objectives.
Develop operational strategy and clinical operations plans in support of the Clinical Development Plan.
Partner and collaborate with cross-functional stakeholders such as the Project Leader, Clinical Lead and other relevant stakeholders.
Lead and oversee execution of first-in-human through phase 4 trials, depending on lifecycle of the program, in compliance with ICH/GCP, local regulations, and Moderna SOPs.
Manage invoice and budget tracking for individual studies and contribute to budget forecasting activities.
Support the selection, oversight, and management of CROs and other vendors; oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team.
Review and provide clinical operations input into relevant clinical documents (protocol, investigator brochure, regulatory documents, clinical study reports, and related plans).
Manage the cross-functional team and CRO/vendor(s) related to all aspects of clinical trial operations; represent Clinical Operations on cross-functional project teams and vendor/CRO operational meetings.
Represent Moderna externally to Investigators, site staff, and Key Opinion Leaders; perform sponsor oversight of outsourced clinical activities.
Communicate study status, cost, and issues to enable timely decision-making by senior management; contribute to monthly and annual forecasting for studies and programs.
Oversee/collaborate on inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct; participate in creation, review, training, and maintenance of SOPs.
Lead and/or participate in clinical operations workstreams related to departmental and operating model initiatives; develop and foster relationships with key stakeholders within Moderna and externally.
Provide mentorship to assigned Clinical Trial Managers and Clinical Trial Associates; promote continuous improvement of clinical development processes.
Act as a role model for Moderna’s values and travel as required.
Qualifications
Minimum of BA/BS with 8–10 years of trial and clinical program experience, including at least 4 years of independent clinical trial management and full lifecycle experience (start-up, conduct, closure); Advanced degree preferred.
Robust experience in oncology; experience in immuno-oncology desirable; experience in ultra-rare diseases desirable but not required. Familiarity with high-complexity and late-stage trials, including inspection readiness activities.
Multi-dimensional Clinical Operations background with the ability to devise plans for operational challenges such as site activation, enrollment, monitoring oversight, protocol deviation management, and data cleaning.
Cross-collaboration proficiency with Regulatory, CMC, Biostatistics, Data Management, Finance, Program Management, and other functions.
Experience in GCP inspections/audits; outstanding verbal and written communication skills; strong organizational abilities.
Proven leadership and team-building skills in a multi-disciplinary biotech/pharmaceutical setting; resilient, creative, and capable problem-solver.
Ability to establish and maintain relationships with key opinion leaders; some travel required.
At Moderna, we believe that when you feel your best, you can do your best work. Our benefits and well-being resources support you at work and beyond, including healthcare coverage, well-being programs, and family planning benefits. We offer paid time off, savings/benefit programs, and location-specific perks. Moderna is an equal opportunity employer and provides accommodations upon request. This position may involve access to export-controlled information and requires eligibility to work in the United States per regulatory requirements.
Location: Cambridge, MA
#J-18808-Ljbffr
Responsibilities
Accountable for delivery of assigned clinical study budget, timelines, and resource management with a focus on quality; make recommendations and decisions regarding operational strategies to support study and/or program objectives.
Develop operational strategy and clinical operations plans in support of the Clinical Development Plan.
Partner and collaborate with cross-functional stakeholders such as the Project Leader, Clinical Lead and other relevant stakeholders.
Lead and oversee execution of first-in-human through phase 4 trials, depending on lifecycle of the program, in compliance with ICH/GCP, local regulations, and Moderna SOPs.
Manage invoice and budget tracking for individual studies and contribute to budget forecasting activities.
Support the selection, oversight, and management of CROs and other vendors; oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team.
Review and provide clinical operations input into relevant clinical documents (protocol, investigator brochure, regulatory documents, clinical study reports, and related plans).
Manage the cross-functional team and CRO/vendor(s) related to all aspects of clinical trial operations; represent Clinical Operations on cross-functional project teams and vendor/CRO operational meetings.
Represent Moderna externally to Investigators, site staff, and Key Opinion Leaders; perform sponsor oversight of outsourced clinical activities.
Communicate study status, cost, and issues to enable timely decision-making by senior management; contribute to monthly and annual forecasting for studies and programs.
Oversee/collaborate on inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct; participate in creation, review, training, and maintenance of SOPs.
Lead and/or participate in clinical operations workstreams related to departmental and operating model initiatives; develop and foster relationships with key stakeholders within Moderna and externally.
Provide mentorship to assigned Clinical Trial Managers and Clinical Trial Associates; promote continuous improvement of clinical development processes.
Act as a role model for Moderna’s values and travel as required.
Qualifications
Minimum of BA/BS with 8–10 years of trial and clinical program experience, including at least 4 years of independent clinical trial management and full lifecycle experience (start-up, conduct, closure); Advanced degree preferred.
Robust experience in oncology; experience in immuno-oncology desirable; experience in ultra-rare diseases desirable but not required. Familiarity with high-complexity and late-stage trials, including inspection readiness activities.
Multi-dimensional Clinical Operations background with the ability to devise plans for operational challenges such as site activation, enrollment, monitoring oversight, protocol deviation management, and data cleaning.
Cross-collaboration proficiency with Regulatory, CMC, Biostatistics, Data Management, Finance, Program Management, and other functions.
Experience in GCP inspections/audits; outstanding verbal and written communication skills; strong organizational abilities.
Proven leadership and team-building skills in a multi-disciplinary biotech/pharmaceutical setting; resilient, creative, and capable problem-solver.
Ability to establish and maintain relationships with key opinion leaders; some travel required.
At Moderna, we believe that when you feel your best, you can do your best work. Our benefits and well-being resources support you at work and beyond, including healthcare coverage, well-being programs, and family planning benefits. We offer paid time off, savings/benefit programs, and location-specific perks. Moderna is an equal opportunity employer and provides accommodations upon request. This position may involve access to export-controlled information and requires eligibility to work in the United States per regulatory requirements.
Location: Cambridge, MA
#J-18808-Ljbffr