Director, Clinical Development, Oncology

Employer
Moderna
Location
Cambridge, MA
Salary
Competitive
Posted
July 12 2019
Ref
R1738
Discipline
Life Sciences, Oncology
Organization Type
Biotech
Director, Clinical Development, Oncology

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, including programs that are malignant hematology focused. Experience in early 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.), Doctor of Osteopathy (D.O.) 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


Here's What We'll Bring to the Table:
  • Daily on-site catered lunches
  • Company-provided iPhone
  • Free parking, monthly subway pass or a subsidized commuter rail pass
  • Free annual corporate membership to Bluebikes
  • Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
  • Flexible Spending Accounts for medical expenses and dependent care expenses
  • 16 weeks of 100% paid parental leave for all new parents
  • 16 weeks 100% paid family caregiver leave
  • 20 weeks 100% paid medical leave
  • Adoption assistance and discounts to local childcare centers, as well as access to care.com
  • 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
  • A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
  • Voluntary legal assistance plan
  • 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)


Why join Moderna

At Moderna, we believe messenger RNA, or mRNA, is the "software of life." Every cell in the body uses mRNA to provide real-time instructions to make the proteins necessary to drive all aspects of biology, including in human health and disease. Given its essential role, we believe mRNA could be used to create a new category of medicines with significant potential to improve the lives of patients.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; and the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been ranked in the top ten of Science's list of top biopharma industry employers for the past four years. To learn more, visit www.modernatx.com .

Our Mission:
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.

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 person's 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.

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