Associate Director, Clinical Sciences - Oncology

The Role This role will support Oncology Therapeutic programs, specifically supporting the Clinical Development Lead in the direction, execution and evaluation of Phase 1-3 clinical studies. The principal responsibility for this role is ensuring the comprehensive data quality of clinical studies to support internal governance decisions and support regulatory submissions. Here’s What You’ll Do In conjunction with the Clinical Development Lead and the broader clinical development team, contribute to regulatory and clinical program strategy, clinical trial design and clinical study execution. Author and review clinical study documents in compliance with regulatory standards, including: clinical protocols, informed consent documents, Development Safety Update Reports (DSUR) and clinical components of Investigator Brochures, INDs and marketing applications. Collaborate with the Clinical Development Lead in the oversight of clinical studies. May lead a clinical study with oversight from the Clinical Development Lead to provide clinical study leadership, review and interpretation of clinical data, and ensure timely execution of deliverables in collaboration with internal and external partners. Perform and coordinate clinical data review and analysis of study data, including review of case report forms, data listings, medical coding and patient profiles to ensure the proper and complete verification of clinical data. In collaboration with the Clinical Development Lead and Clinical Safety & Pharmacovigilance, support managing study sites to ensure that study treatment discontinuation or other safety decisions are made in alignment with the protocol. Collaborating with Clinical Operations, participate in the start-up and execution of global clinical studies to ensure on-schedule site activation and subject enrollment of a clinical trial. Design and implement clinical study parameters to minimize operational risk and increase study site performance and efficiency. Collaborate on and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct. Develop the strategy and drive the messaging and associated content for Investigator Meetings, investigator engagement and Advisory Board meetings. Responsibility for training and educating junior Clinical Science personnel. Support and help drive the evolution of the clinical science role at Moderna and support process updates. Participate in Development workstreams related to the clinical trial delivery operating model. Here’s What You’ll Need A personal and professional commitment to the highest personal and ethical standards. A high-performing, self-motivated and energetic individual who demonstrates outstanding scientific and clinical oncology knowledge that results in the conduct of well-executed clinical research. A history of successfully operating in a matrix environment and the demonstration of highly developed interpersonal and communication skills. Capability to successfully contribute to both early and late-stage clinical development programs. This will involve close with Drug Discovery, Translational Medicine, Regulatory Affairs, Biostatistics, Medical Affairs and Commercial. Here’s What You’ll Bring to the Table The individual must have the demonstrated ability to successfully work in a team environment. This role is best suited for candidates holding a PhD, PharmD, Masters’ or advanced nursing degree with significant scientific and clinical oncology knowledge, pharmaceutical/biotechnology company experience and a comprehensive knowledge of drug development. A minimum of 10 years of clinical development experience within a pharmaceutical/biotechnology company. Significant experience with clinical study design and protocol development. Significant experience with ensuring data integrity, data analysis and data presentation. Excellent written communication, oral communication, and presentation skills. Ability to travel up to 15% required for travel to work with study sites and attend national and international scientific congresses. This role is based in our new LEED-certified HQ in Cambridge, MA, or Princeton, NJ office and is expected to be in-office 70% of the time with flexibility to work from home up to 30%. 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 $183,800.00 - $330,300.00. 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. 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. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! 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 View email address on click.appcast.io. 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. Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. #J-18808-Ljbffr Initial Therapeutics, Inc.