Director, Global Clinical Lead, Rare Disease

Employer
Moderna
Location
Cambridge, MA
Salary
Competitive
Posted
March 07 2019
Ref
R1032
Discipline
Life Sciences, Biology
Organization Type
Biotech
Director, Global Clinical Lead, Rare Disease

The Role:

Moderna is seeking an experienced physician scientist to lead autoimmune drug development for their mRNA-based programs. This role will report to the Chief Medical Officer and have direct medical responsibility for certain rare disease development programs, including creating overall clinical development plans, designing clinical studies, writing protocols, ensuring timely execution and medical monitoring all in close collaboration with Moderna's internal clinical research and platform organizations and relevant external pharmaceutical partners.

The successful candidate will thrive in a proactive, fast-paced 'can-do' culture and enjoy collaborating across the full range of development activities for the ground-breaking, mRNA-based new drug candidates targeting rare disease, in addition to being a highly-effective internal and external team player and terrific communicator and relentless contributor.

Here's What You'll Do:
  • Provide clinical leadership for rare drug discovery and development, serve as top 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 translational medicine
  • Act as subject matter expert on all clinical and medical strategic initiatives
  • Design and develop clinical development plans, study protocols and interpret clinical study data, including review of the pre-clinical package
  • 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., pre-IND meeting packages, IND/CTA, IB, ICF and BLA/NDA), prepare for meetings with FDA and healthcare authorities and organize and prepare for Clinical Advisory Board meetings
  • Serve as an exemplary leader; mentor, train and develop cross-functional staff, as needed
  • Leadership on certain rare disease clinical trials with adherence to cGCP and FDA Regulatory compliance
  • Represent the Company externally to Investigators and trial site administrators
  • Develop and maintain strong, collaborative relationships with key stakeholders in Clinical Development and the broader Moderna organization.


Here's What You'll Bring to the Table:
  • MD or MD/PhD a minimum of 5 years of demonstrated knowledge and experience in clinical research in rare disease as well as significant knowledge and experience in the design and execution of clinical trials
  • Demonstrated track record in leading cross-functional teams and work streams (e.g., biostatistics, regulatory, pre-clinical pharmacology and pharmaceutical sciences)
  • Demonstrated scientific accomplishment enabling rapid understanding of the mRNA technology.
  • Marked proficiency in clinical/medical writing and verbal communication
  • 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
  • Outstanding verbal and written communication skills, in addition to excellent organizational skills
  • Creative, capable and relentless problem-solver
  • Track record of dogged pursuit of solutions for patients
  • History of taking bold, but calculated risks
  • Common sense.


Here's What We'll Bring to the Table:
  • Daily on-site catered lunches [ Cambridge ] On-site subsidized cafeteria [ Norwood ]
  • Company-provided iPhone
  • Free parking, monthly subway pass or a subsidized commuter rail pass
  • 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


Why join Moderna Therapeutics

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.

#LI-AE1

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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