Moderna
Associate Director, Trial Feasibility
Moderna, Cambridge, Massachusetts, us, 02140
The Role:
Reporting to the Director, Study Start-up, the Associate Director, Trial Feasibility will be responsible for developing and managing overall trial feasibility outputs for Moderna's pipeline of clinical programs. This role will work closely with Clinical Operations teams, and other key internal/external stakeholders to drive trial feasibility activities for all Moderna trials. The Associate Director, Trial Feasibility will support across the Moderna pipeline, including Infectious Disease, Oncology, and Therapeutics. In this role, you will drive data-driven decision-making through delivery of trial landscape analyses inclusive of, trial disease population, competitive analysis, clinical landscape, country regulatory and start up considerations, site and participant prevalence, logistics, and infrastructure. You will be responsible for collaborating with internal teams to ensure key operational insights are incorporated into patient recruitment and retention strategies, and that trial landscape analysis findings are incorporated into site feasibility. This role is highly collaborative and analytical, and requires expert facilitation skills, ability to influence in a matrix-style organization, experience in clinical trial design, operations, and management.
Here's What You'll Do:Deliver strategic guidance and expertise to Clinical Operations teams in development of operationally feasible trial designs and high-level trial delivery strategies
Drive data-driven decision making through delivery of trial landscape analysis, inclusive of trial disease population, competitive analysis, clinical landscape, country regulatory and start up considerations, site and participant prevalence, logistics, and infrastructure.
Leverage internal and third-party data sources, as well as centralized and local cross-functional insights
Facilitate cross-functional Clinical Trial team interactions to assess overall trial design and feasibility and ensure trial feasibility and site feasibility strategies are aligned and processes integrated
Design, prepare, and run cross-functional meetings and forums to be effective and for clear outcomes
Contribute to development of in-house feasibility capabilities, processes and standardized deliverables to improve operational effectiveness/trial performance by utilizing analytical inputs
Here's What You'll Bring to the Table:
Minimum of bachelor's degree or equivalent in a scientific or health-related field
Minimum of 8 years of experience in the biotech/pharmaceutical industry and/or clinical research setting
At least 5 years of direct responsibility in leading strategic trial feasibility assessments of global clinical research trials in a sponsor and/or CRO setting
Expertise in development and execution of country/site identification, feasibility, and startup strategies and familiarity with feasibility tools and datasets
Therapeutic expertise/experience in infectious disease/vaccines, oncology, and rare/autoimmune disease areas preferred. Ability to acquire and maintain therapeutic expertise to support portfolio needs
Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization
Knowledge of drug development, a thorough understanding of the processes associated with trial feasibility, clinical trial start-up, and business operations
Well-developed strategic planning, observation, analytical operational execution, and problem-solving skills
Strong interpersonal skills, including ability to persuade, negotiate, and manage conflict
Demonstrated leadership behaviors with ability to accept challenges, seek opportunities to remove barriers, influence across an organization, and lead in areas of uncertainty
Excellent communication skills; fluent in both written and spoken English; able to produce reports and project plans to a high standard
Must have competent computer skills in MS Word, Excel, and PowerPoint
Embody the Moderna values: BOLD in imagining what's possible; RELENTLESS in overcoming obstacles and driving to conclusions; COLLABORATIVE in working with, learning from, and teaching others; and CURIOUS in learning about cutting edge science
Moderna 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 holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid 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, the infrastructure 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 people are 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. We're 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)
Reporting to the Director, Study Start-up, the Associate Director, Trial Feasibility will be responsible for developing and managing overall trial feasibility outputs for Moderna's pipeline of clinical programs. This role will work closely with Clinical Operations teams, and other key internal/external stakeholders to drive trial feasibility activities for all Moderna trials. The Associate Director, Trial Feasibility will support across the Moderna pipeline, including Infectious Disease, Oncology, and Therapeutics. In this role, you will drive data-driven decision-making through delivery of trial landscape analyses inclusive of, trial disease population, competitive analysis, clinical landscape, country regulatory and start up considerations, site and participant prevalence, logistics, and infrastructure. You will be responsible for collaborating with internal teams to ensure key operational insights are incorporated into patient recruitment and retention strategies, and that trial landscape analysis findings are incorporated into site feasibility. This role is highly collaborative and analytical, and requires expert facilitation skills, ability to influence in a matrix-style organization, experience in clinical trial design, operations, and management.
Here's What You'll Do:Deliver strategic guidance and expertise to Clinical Operations teams in development of operationally feasible trial designs and high-level trial delivery strategies
Drive data-driven decision making through delivery of trial landscape analysis, inclusive of trial disease population, competitive analysis, clinical landscape, country regulatory and start up considerations, site and participant prevalence, logistics, and infrastructure.
Leverage internal and third-party data sources, as well as centralized and local cross-functional insights
Facilitate cross-functional Clinical Trial team interactions to assess overall trial design and feasibility and ensure trial feasibility and site feasibility strategies are aligned and processes integrated
Design, prepare, and run cross-functional meetings and forums to be effective and for clear outcomes
Contribute to development of in-house feasibility capabilities, processes and standardized deliverables to improve operational effectiveness/trial performance by utilizing analytical inputs
Here's What You'll Bring to the Table:
Minimum of bachelor's degree or equivalent in a scientific or health-related field
Minimum of 8 years of experience in the biotech/pharmaceutical industry and/or clinical research setting
At least 5 years of direct responsibility in leading strategic trial feasibility assessments of global clinical research trials in a sponsor and/or CRO setting
Expertise in development and execution of country/site identification, feasibility, and startup strategies and familiarity with feasibility tools and datasets
Therapeutic expertise/experience in infectious disease/vaccines, oncology, and rare/autoimmune disease areas preferred. Ability to acquire and maintain therapeutic expertise to support portfolio needs
Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization
Knowledge of drug development, a thorough understanding of the processes associated with trial feasibility, clinical trial start-up, and business operations
Well-developed strategic planning, observation, analytical operational execution, and problem-solving skills
Strong interpersonal skills, including ability to persuade, negotiate, and manage conflict
Demonstrated leadership behaviors with ability to accept challenges, seek opportunities to remove barriers, influence across an organization, and lead in areas of uncertainty
Excellent communication skills; fluent in both written and spoken English; able to produce reports and project plans to a high standard
Must have competent computer skills in MS Word, Excel, and PowerPoint
Embody the Moderna values: BOLD in imagining what's possible; RELENTLESS in overcoming obstacles and driving to conclusions; COLLABORATIVE in working with, learning from, and teaching others; and CURIOUS in learning about cutting edge science
Moderna 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 holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid 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, the infrastructure 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 people are 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. We're 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)