Associate Director, Clinical Operations – Therapeutics/Oncology

Moderna; Cambridge (MA); Vor Ort; USD 143.000 - 257.000; Vollzeit

Benefits dieser Stelle

Competitive healthcare

Generous paid time off

Location-specific perks

Zusammenfassung

Moderna seeks an Associate Director of Clinical Operations to lead studies in the Therapeutics/Oncology space, directing trials across all phases and overseeing CROs and vendors. You will work with cross-functional partners to develop operational strategies and ensure successful execution of development programs.

You will manage budgets, timelines, and resource allocation, contribute to study documentation and regulatory submissions, and mentor Clinical Trial Managers and Associates while

Qualifikationen

• BA/BS with 8–10 years of trial and clinical program experience; advanced degree preferred.
• Robust experience in therapeutics/oncology; early development and immuno-oncology desirable.
• Multi-dimensional Clinical Operations background for site activation, enrollment, monitoring, etc.
• Cross-collaboration with Regulatory, CMC, Biostatistics, Data Management, Finance, PM.
• Experience in GCP inspections/audits.
• Strong communication and organizational skills; demonstrated leadership within a multi-disciplinary team.

Aufgaben

• Deliver study budgets, timelines, and resources with a focus on quality.
• Develop operational strategy in support of the Clinical Development Plan.
• Lead end-to-end trials from first-in-human through phase 4, in compliance with SOPs.
• Oversee CROs and vendors; manage site feasibility and capabilities.
• Review documents (protocol, ICF, regulatory documents) for input from Clinical Operations.
• Represent Clinical Operations on cross-functional teams and external interactions.

Kenntnisse

Trial management

Cross-functional collaboration

Budget management

Leadership & mentoring

ICH/GCP compliance

Vendor/CRO oversight

Ausbildung

BA/BS in life sciences

Advanced degree preferred

Tools

CTMS

Budget tracking software

Jobbeschreibung

The Role

Moderna is seeking an Associate Director of Clinical Operations to manage studies within the Therapeutics/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.

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
• 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 experience in therapeutics/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/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

At Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.

• 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.

Our Working Model

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.

Moderna is a smoke-free, alcohol-free, and drug-free work environment.

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.