Associate Director, Clinical Operations – Oncology/Therapeutics

Moderna Inc.; Cambridge (MA); On-site; USD 143,000 - 257,000; Full time

Benefits offered by this job

Healthcare

Well-being programs

Family planning support

Paid time off

Retirement savings

Location-specific perks

Job summary

Moderna is seeking an Associate Director of Clinical Operations to manage and oversee studies within the Oncology/Therapeutics portfolio, including autoimmune and other complex modalities. This role will lead trials across all phases, work with CROs/vendors, and drive cross-functional strategy.

The ideal candidate has strong experience in first-in-human studies and autoimmune or immune-mediated diseases, with the ability to manage budgets, timelines and cross-functional collaborations within a

Qualifications

• BA/BS with 8–10 years of trial and clinical program experience, including at least 4 years of independent clinical trial management and full trial life cycle experience.
• Robust Clinical Operations experience in autoimmune, oncology, neuroimmunology, CAR-T/cell therapy, gene therapy or other complex modalities.
• Cross-functional collaboration with Regulatory, CMC, Biostatistics, Data Management and Finance.
• Experience in GCP inspections/audits and in leading multi-disciplinary teams.
• Strong leadership, communication, and problem-solving skills with ability to work independently.

Responsibilities

• Deliver clinical study budgets, timelines and resources with a focus on quality.
• Develop operational strategy and Clinical Development Plan execution plans.
• Lead and oversee first-in-human through phase 4 trials, including CRO/vendor oversight.
• Communicate study status, costs and issues to senior management for timely decisions.
• Represent Clinical Operations on cross-functional teams and vendor meetings to ensure SOP compliance.
• Mentor assigned Clinical Trial Managers and Associates and drive continuous improvement.

Skills

Clinical operations leadership

Trial management

ICH/GCP compliance

Cross-functional collaboration

Budget management

Vendor management

First-in-human experience

Education

BA/BS

Advanced degree preferred

Job description

The Role

Moderna is seeking an Associate Director of Clinical Operations to manage/oversee studies within the Oncology/Therapeutics portfolio, including programs across autoimmune and other complex or emerging therapeutic modalities. 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.

The ideal candidate will bring strong experience leading complex early-phase clinical trials, particularly first-in-human studies, with experience in one or more relevant therapeutic areas such as autoimmune or immune-mediated disease, immuno-oncology/oncology, neuroimmunology/multiple sclerosis, cell therapy/CAR-T, gene therapy, or other advanced therapeutic modalities.

This position reports to the Director/Sr. 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.

Here’s What You’ll 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 objectives
• Develop operational strategy and clinical operations plans in support of execution 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 program, in compliance with ICH/GCP, local regulations, and Moderna SOPs, with particular emphasis on the operational complexities associated with early clinical development, first-in-human studies and autoimmune studies.
• Manage invoice and budget tracking for individual studies and provide input into 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 such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
• Manage the cross functional team and CRO/vendor(s) related to all aspects of clinical trial operations
• Responsible for representing Clinical Operations on cross-functional project teams and vendor/CRO operational meetings and ensuring compliance with operational standards and procedures
• Along with other Clinical Development personnel, represent Moderna externally to Investigators, site staff, and Key Opinion Leaders
• Perform and document study level Sponsor Oversight of outsourced clinical activities
• Communicate study-status, cost and issues to ensure timely decision-making by senior management
• Manage invoice and budget tracking for individual studies and provide input into monthly and annual forecasting activities for studies and programs
• Oversee/collaborate on and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct
• Maintain oversight and participate in the creation/review/training/maintenance of departmental and organizational SOPs to ensure compliance
• Lead and/or participate in clinical operations workstreams related to departmental and operating model related initiatives
• Develop and foster strong, collaborative relationships with key stakeholders both within and external to Moderna
• Support program level deliverables/activities at the discretion of the Senior Director, Clinical Operations
• Provide oversight and mentorship to assigned Clinical Trial Managers and Clinical Trial Associates by providing clinical operations and functional area expertise
• Strive for continuous improvement and more efficient ways of working in clinical development
• Act as a role model for Moderna’s values

Here’s What You’ll Need (Basic Qualifications)

• 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 Clinical Operations experience in one or more relevant therapeutic areas or complex modalities required, including autoimmune disease, oncology, neuroimmunology/multiple sclerosis, CAR-T/cell therapy, gene therapy, or another complex therapeutic modality.
• 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/audits
• Outstanding verbal and written communication skills, in addition to excellent organizational skills
• Proven track record of effective leadership and team-building skills in the context of a multi-disciplinary team in the biotech or pharmaceutical industry
• Resilient, Creative, capable problem-solver
• Excellent organizational skills and ability to work independently
• Experience in establishing and maintaining relationships with key opinion leaders
• Some travel required

Pay & Benefits

• Competitive healthcare, plus voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Family planning benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investments to help you plan for the future
• Location-specific perks and extras

The salary range for this role is $142,500.00 - $256,500.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.

The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.

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.

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.

Equal Opportunities

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 a place where everyone can grow.

Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Accommodations

We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can 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 [e-mail] .

Export Control Notice

This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.