Head of Clinical Development Operations
Are you looking for a role with impact?
Magenta Therapeutics is a company dedicated to addressing significant needs across all aspects of transplant medicine with a culture fueled by an amazing, passionate group of people committed to the idea of “patients first” and making a difference.
We started with an idea— Significant needs remain for patients living with autoimmune diseases, blood cancers, and rare genetic diseases. Bone marrow transplant is a potential cure for many, but its high risks, toxic side effects and complexity prevent many patients from being able to benefit. Magenta is working comprehensively to change the transplant journey for patients.
By pioneering an innovative portfolio of novel therapeutics designed to make the entire bone marrow transplant process more effective, safer and easier, we aim to unleash the full potential of bone marrow transplant for those living with a wide array of conditions such as multiple sclerosis, scleroderma, acute myeloid leukemia, myelodysplastic syndromes, inherited metabolic diseases, and sickle cell disease.
The people at Magenta are at the very core of our progress in pursuing this vision. Our roles don’t dictate our daily activities – every employee is empowered to make an impact, seize opportunity and to develop skills and expertise.
The Head of Clinical Operations will be responsible for developing the global clinical development strategy and execution of clinical trials for all of Magenta’s clinical programs that include cell therapy, stem cell mobilization, and antibody drug conjugates across multiple therapeutic indications. This role will oversee the Clinical Operations team to ensure all assigned operational trial deliverables across programs are completed according to timelines budget, operational procedures, quality standards, SOPs and business guidelines. This individual will need expertise in successful planning, implementation, and delivery of clinical operations strategy, plans and study execution. This individual will also be responsible for managing and supporting vendor/CRO relationships and activities including negotiations and performance evaluations. This individual will be a member of the R&D leadership team and will be a significant contributor to the overall R&D strategy.
You are perfect for this role if you are engaged by and want to be responsible for:
- Provide strategic and technical guidance to, and manage CRO/vendor clinical operations resources for the execution of clinical stage programs
- Provide oversight for the participation and evaluation of development strategy feasibility for full life cycle of studies
- Drive creation of clinical operations standards, systems, and processed across the clinical stage programs
- Communicate with and supervise team members and external vendors in the Clinical Operations function, and provide management and guidance across the function
- Plan for and prioritize activities and resources, in line with the clinical development strategy for each program
- Ensure that external vendors are selected and managed to deliver within established timelines and financial investment
- Create strategy and manage the CRO vendor partnerships
- Effectively communicate timelines and relevant updates to management, all team members and ancillary parties involved in the successful execution of program(s)
- Ensure quality, compliance and efficiency by optimizing processes, identifying and implementing best practices and knowledge sharing
- Oversee the preparation and completion of clinical study protocols, CRFs and other study related materials for all assigned clinical programs
- Oversee the data collection activities for all assigned clinical programs. Ensure quality data is available to support annual reports, investigator brochures, regulatory filings, safety summaries, project team summaries, etc.
- Oversight and management of other vendors/contractors/consultants for biostatistics, data management, and pharmacovigilance
We would be thrilled if you brought the following with you:
- Bachelor’s degree with a minimum of 10 years of relevant experience in clinical operations or equivalent experience in the pharmaceutical/clinical research environment with cross-functional operational execution
- In-depth understanding and working knowledge of ICH/GCP guidelines and FDA regulations and drug development processes
- Prior management/supervisory experience and significant expertise in the oversight of clinical trials
- Ability to work on problems of diverse scope and extremely complex in nature which may cross many functional areas
- Proven ability to lead in a manner that creates a motivated, committed and engaged clinical development operations teams, internal and external, including data management, pharmacovigilance, statistical programming, clinical compliance and medical writing
- Proven ability to communicate and function effectively across a matrix organization with multiple stakeholders
- Experience in clinical development of cellular therapies, biologics, and small molecules
- Demonstrated experience in successfully leading teams in an effective, efficient manner
- Direct experience in preparation of regulatory submissions, presentation to regulatory advisory panels in support of registration of a new drug
- Experience in developing global clinical development strategy and execution of these in multiple therapeutic areas
To be successful as a leader and contributor within Magenta, you must be:
- 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
- Entrepreneurial. You will enjoy learning and being involved in the content of our whole business, thriving on a very fast-paced and growing business
- Intuitive. You will have a demonstrated ability to work in the “gray zone” and anticipate challenges before they arise
- A proven cross-functional leader.You will have demonstrated the ability to “influence without authority,” build teams, and achieve objectives across complex projects and organizational structures
- Process-oriented, yet flexible. You will appreciate and be able to create and drive process, and at the same time recognize when rules are meant to be bent
- Transparent and Articulate.You will have the ability to communicate clearly and concisely with all stakeholders
- Enterprise-focused and Business-savvy.You will always seek to put the goals of the company first, and help others understand the tradeoffs we need to make across the business. You’ll also be interested in new business development opportunities, being able to bring those to the attention of the right teams at Magenta and able to support those activities as requested
- 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