Director, Clinical Development, Oncology

Company: Moderna
Location: Cambridge
Posted on: May 28, 2023

Job Description:

The Role:

Moderna is seeking a board-certified medical hematologist/oncologist with pharmaceutical experience to lead Clinical Development for one or more of their immuno-oncology-based development programs. Experience in late phase drug development is a plus. This role will report to the Head of Clinical Development for Moderna and have direct medical responsibility for the clinical development programs including creating overall clinical development plans, designing clinical studies, writing protocols, ensuring timely execution and medical monitoring all in close collaboration with relevant internal and external pharmaceutical partners and Clinical Research Organizations. There is approximately 10% travel expected as part of this role.

The successful candidate will thrive in a proactive can-do culture and enjoy working across the full range of clinical development activities for the ground-breaking, mRNA-based immuno-oncology-based new drug candidates in addition to being a highly-effective internal and external team player and terrific communicator and collaborator.

Here's What You'll Do:

• Provide clinical leadership for individual programs at the Project Team Level, including serving as key representative for clinical development/medical strategy areas both internal and external facing (e.g., CRO, KOL and clinical site staff)
• Serve as cross-functional leader on all Medical and clinical work streams including clinical pharmacology, statistics, clinical operations, regulatory affairs, and preclinical science and translational medicine
• Responsible for the design and development of clinical development plans, study protocols and interpretation and analysis of clinical study safety and efficacy data, including review of the pre-clinical package. Responsible for Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables.
• Act as subject matter expert on all clinical and medical strategic initiatives for their programs
• Primary responsibility for preparations of external meeting abstracts, posters, presentations related to clinical trial data
• Consult with external and internal subject matter experts to agree go/no-go development decision criteria
• Implement safety strategy across studies, including regular review of safety data (including but not limited to SAEs) and response to safety issues
• Lead clinical sections of regulatory documents (e.g., IND, DMF and BLA/NDA), prepare for meetings with FDA and healthcare authorities and organize and prepare for Advisory Board meetings
• Implementation of clinical trials with adherence to cGCP and FDA Regulatory compliance
• May participate in due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies.
• Develop and maintain strong, collaborative relationships with key stakeholders in Clinical Development and the broader Moderna organization
• Represent the Company externally to Investigators, trial site administrators and sit on Joint Development Committee for programs performed in collaboration with other Pharma companies. Here's What You'll Bring to the Table:
  • Medical Doctor (M.D.), or non-US equivalent of M.D. degree with relevant hematology and/or oncology in an academic or hospital environment. Completion of a residency program strongly preferred. Completion of a pediatric or medical hematology and/or oncology fellowship is desirable.
  • Minimum 3 years' experience in immune-oncology or oncology clinical drug development, preferably in a pharmaceutical or biotechnology company, as well as significant knowledge and experience in the design and execution of clinical trials. Background working in development programs that heavily integrate translational medical approaches a must.
  • Demonstrated track record in leading cross-functional teams and work streams (e.g., translational medicine, biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences)
  • Outstanding verbal and written communication skills, in addition to excellent organizational skills
  • Understanding of the entire drug development process, including clinical and non-clinical study design and execution
  • Experience in early-stage programs
  • Experience in leading the selection and oversight of CROs and other vendors
  • Oversee activities leading to internal cGCP audits and regulatory inspections related to clinical trial conduct
  • Thorough command of FDA, MHRA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies in the United States, Europe and rest of world
  • Experience in regulatory cGCP inspections and audits 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 year-end shutdown
      --- 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!
      
      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 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 make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
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Keywords: Moderna, Cambridge , Director, Clinical Development, Oncology, Executive , Cambridge, Massachusetts