Toxicologist

Location
Cambridge, MA, United States
Posted
Sep 30, 2020
Ref
4848827002
Required Education
Doctorate/PHD/MD
Position Type
Full time
Magenta Therapeutics is a clinical-stage biotechnology company developing therapeutics to reset the immune system to cure more patients with devastating and life-threatening diseases. This immune reset approach can be applied through stem cell transplant to multiple diseases, including autoimmune diseases, such as multiple sclerosis and systemic sclerosis; blood cancers, such as acute myeloid leukemia; and genetic diseases, such as sickle cell disease.

Magenta's comprehensive approach to precision immune system reset will transform many aspects of the transplant process, aiming to make it safer and more effective. Our culture is fueled by a driven, passionate group of people committed to making a difference, seizing opportunities for maximum impact and pursuing progress for the patients we seek to serve.

The Toxicologist will be responsible for the design, leadership, and implementation of nonclinical safety strategies across Magenta's research and development programs. This position will report to the Senior Vice President of Translational Sciences. He/she should be familiar with current practices in the following areas: discovery and regulatory toxicology, DMPK and translational research. He/she should have a strong knowledge of best regulatory practices, extensive experience designing and executing the breadth of nonclinical safety studies to support lead candidate selection through product registration, and a demonstrated ability to make data-driven decisions based on nonclinical and clinical information. The ideal candidate is a creative and innovative scientist who has lead nonclinical safety efforts for the successful discovery and development of protein therapeutics across many biologics modalities, such as monoclonal antibodies, antibody drug conjugates, and peptides. This individual will work in close collaboration with colleagues in Clinical Development, Translational Sciences, Bioanalysis, Project Management, Research, and Regulatory Affairs to execute the company's overall development strategy, participate on cross-functional project teams, and contribute to interactions with global health authorities.

This role provides the rare opportunity for a growing professional to develop their skills through collaboration with the senior most levels of the organization, while making strategic and tactical impact on the things that matter most - driving our science to help patients.

You are perfect for this role if you are engaged by:
  • Leading the nonclinical safety strategy with vision to create scientifically sound, innovative and efficient programs that meet regulatory requirements, corporate and R&D program goals, and facilitate expedient development from discovery research to Phase 1 and on to registration.
  • Independently representing Toxicology as a member of program, nonclinical, and clinical trial working teams, and contributing to candidate selection strategy, and designing, executing, and finalizingnonclinical study reports.
  • Partnering with the discovery group and working with nonclinical DMPK colleagues to optimize nonclinical models and inform first in patient clinical dosing strategies.
  • Reviewing nonclinical study reports, in conjunction with Pharmacology / DMPK and preparing submission documentation.
  • Identifying and managing consultants and vendors to support toxicology studies.
  • Accountable for adherence to agreed timelines and budgets to ensure execution of deliverables from nonclinical safety studies and programs.
  • Collaborating cross functionally with all relevant areas to support corporate objectives.

We would be thrilled if you brought the following with you:
  • Ph.D. or equivalent training in toxicology or related disciplines with at least 5 years of bio/pharmaceutical industry drug development experience in nonclinical safety/toxicology.
  • Strong understanding of toxicology principles, the drug development process and regulatory guidance to support nonclinical safety strategies for FIH studies through product registration.
  • Experience with preparation of the clinical pharmacology portions of regulatory documents such as the pre-IND, IND, IB, FIH starting dose justifications, briefing documents, nonclinical study reports, CTA and filing documents, while working in collaboration with cross functional teams.
  • Experience in regulatory submissions for small molecules, biologics, ADCs and cell therapies preferred, with a focus on nonclinical and clinical development global strategy and execution.
  • Ability to exercise good judgement, problem-solving skills, strong analytical and organization skills; attention to detail required.

Successful leaders and contributors within Magenta are:
  • Driven. You will be focused on the achievement of Magenta's mission and major corporate goals.
  • Results-focused. Demonstrated record of exceeding stretch goals, and willing to bring creative problem-solving skills to challenges along the way
  • Intuitive. You will enjoy learning and being involved in the content of our whole business, thriving on a very fast-paced and growing business
  • Collaborative. You will have demonstrated the ability to achieve objectives across complex projects and organizational structures
  • Process-oriented, yet flexible. You will appreciate and be able to create and drive process, while also recognizing when flexibility is needed.
  • Transparent and Articulate. You will have the ability to communicate clearly and concisely with all stakeholders
  • Independent. You will be able to self-organize and operate effectively without significant day-to-day oversight, while staying tightly connected to key leaders and teams across the company
  • A role model for the company's cultural pillars; Courage Commitment & Excellence

At Magenta, we celebrate our differences. We value the power of a diverse array of folks who bring all of themselves to their work. We embrace cultural, cognitive, social, and professional diversity because we know the only way we're going to make new cures possible is by working together.