Skip to main content

This job has expired

You will need to login before you can apply for a job.

Director, Clinical Development, Oncology

Employer
Moderna, Inc.
Location
Cambridge, MA
Start date
Jan 30, 2023

View more

Job Details

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.

Heres What Youll 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.

Heres What Youll 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!

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 persons 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-AK1

-

Company

Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. Moderna’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.

mRNA is now a turning point in the history of science, medicine, technology, even humankind itself. With this breakthrough discovery, many of the world’s biggest and most challenging medical problems are no longer a question of “how?” but merely a question of “when?”

Come with us as we pursue the uncharted reaches of possibility and make your mark on the future of medicine.

 

Stock Symbol:

MRNA  

Stock Exchange:

USNASDAQ GS

 

Facebook  Instagram  Twitter

 

Company info
Website
Phone
617-714-6500
Location
200 Technology Square
Cambridge, MA
United States

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert