Associate Director, Trial Feasibility

The Role: Reporting to the Director, Patient Recruitment & Feasibility, 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 Patient and Site Experience (PASE) leadership team, Clinical Operations teams, Clinical Site Monitoring & Management (CSMM) teams, partner CROs, and other key internal/external stakeholders to drive trial feasibility activities for all Moderna trials on which the PASE team is engaged. 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. We work collaboratively as a team, we boldly strive for excellence, we are constantly curious and committed to ongoing learning and improvement, and we are relentless in putting patients at the heart of what we do. 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 Operations team interactions to assess overall trial design and feasibility Design, prepare, and run cross-functional meetings and forums to be effective and for clear outcomes Contribute to development of in-house feasibility capabilities to improve operational effectiveness/trial performance by utilizing analytical inputs Through close collaboration with CSMM team, ensure trial feasibility and site feasibility strategies are aligned and processes are integrated Collaborate with internal teams to ensure key operational insights are incorporated into integrated PASE strategies Along with CRO partners, contribute to development of shared processes and standardized deliverables across the pipeline to ensure transparency and alignment through start-up 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 options Flexible Spending Accounts for medical expenses and dependent care expenses Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities Family care benefits, including subsidized back-up care options and on-demand tutoring Free premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipment Adoption and family-planning benefits Dedicated care coordination support for our LGBTQ community Generous paid time off, including: • Vacation, sick time and holidays • Volunteer time to participate within your community • Discretionary winter shut down • Paid sabbatical after 5 years; every 3 years thereafter Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning tools Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options Complimentary concierge service including home services research, travel booking, and entertainment requests Free parking or subsidized commuter passes Location-specific perks and extras! Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law. About Moderna In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic. Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com. Moderna is a smoke-free, alcohol-free and drug-free work environment. Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. #LI-MM1 - Our Mission and Vision At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today. Third Party Staffing Agencies Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing humanresources@modernatx.com if you need assistance completing any forms or to otherwise participate in the application process. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. Return Home