Associate Director/Director, Clinical Operations

Location
Cambridge, MA, United States
Posted
Oct 03, 2020
Ref
4879805002
Required Education
Bachelors Degree
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.

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.

We are seeking an Associate Director/Director, Clinical Operations to provide strategic leadership and operational planning expertise to Magenta's clinical development programs. We are looking for an experienced Clinical Program Manager who can lead the creation and high-quality implementation of thoughtful clinical develop plans. This position is both a member of the Program Team and an integral co-leader responsible for the effective operations of the Clinical Subteam, facilitating cross-functional engagement both internally and with vendor partners as part of a fully outsourced operating model.

You are perfect for this role if you are engaged by:
  • Providing operational expertise and strategic input to the development of Clinical Development Plans (CDP) supporting the overall clinical strategy for assigned clinical program(s); may lead some trial management activities within assigned program as well.
  • Providing program-level sponsor oversight of CRO and 3rd party vendors to ensure the effective execution of the clinical studies on time, with high quality (e.g., inspection ready) and within agreed budget.
  • Collaborating with cross-functional counterparts to oversee the performance for all activities assigned to our CROs and vendors, including escalation of issues when necessary.
  • Clinical program budget planning and external spend related to clinical program execution. Working closely with CROs and vendors, Program Management and Finance to ensure that budgets, enrollment, and forecasts are accurate.
  • Reviewing and providing expert clinical operations input into clinical documents including Investigator Brochures, Investigational New Drug Applications (INDs) and/or Investigational Medicinal Product Dossier (IMPDs), study synopsis and protocols, clinical study reports, applicable sections of the New Drug Application (NDA) and/or Marketing Authorization Application (MAA), updates to IND and NDA documents, DSURs and other safety reports; may be responsible for the management of clinical document creation or updates.
  • Providing expert clinical operations input into preparation for key regulatory meetings (e.g. End-of-Phase 2, Request for Scientific Advice Meetings, etc.), as appropriate.
  • Functional leadership which may include line management, providing input for issue resolution and leading and/or support functional strategic initiatives and process improvement.

We would be thrilled if you brought the following with you:
  • Bachelors Degree or international equivalent required, Life Sciences preferred.
  • 8 years' minimum experience in pharmaceutical industry and/or clinical research organization, including clinical study/project management.
  • Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP.
  • Ability to competently manage multiple competing priorities, adapting as needs change. Must be comfortable working in a fast-paced environment.
  • Demonstrated excellence in program management, including scenario assessment, risk assessment and contingency planning
  • Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills
  • Strong communication skills and ability to work with cross-functional study teams
  • Strong organizational skills, sufficient to multi-task in a fast-paced environment with changing priorities
  • Excellent written and oral communication skills, including the ability to effectively communicate statistical concepts in a clear and concise manner.
  • Ability to work independently and act with initiative to address issues

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.