Head of Drug Safety

Title: Head of Drug Safety

Location: Waltham, MA

Reports to: Senior Vice President, Clinical Research and Safety

About AlloVir

AlloVir is a publicly held, high-growth biotechnology company pioneering science in the field of virus-specific T cell (VST) therapies.

We embrace a shared mission to prevent and defeat life-threatening viral disease, champion truth, and challenge the status quo in pursuit of constant improvement.

Our innovative spirit lives beyond the lab, in a world where patients fighting viral infection have access to revolutionary allogeneic cell therapies. A world where everyone has access to a healthy immune system.

Success in this role means partnering across the organization to establish an innovative cell therapy manufacturing supply chain, taking a pro-active approach to identifying and overcoming risks and barriers, and challenging in the pursuit of continuous improvement.

At AlloVir, the expectation is that regardless of title, people are both group leaders and individual contributors. Much like medicine, we believe that this person can both do the work and set the work, working across functions seamlessly, sometimes in the lead position sometimes in support.

The Role

At AlloVir it is our mission to develop and deliver transformative cell therapies for patients suffering from life-threatening virus-associated diseases. We are the leader in the clinical development of novel cell therapies designed to restore natural T-cell immunity against devastating virus-associated diseases in immunocompromised patients, including stem cell and organ transplant recipients. Our proprietary technology platform delivers commercially scalable, “ready-to-administer” solutions by leveraging off-the-shelf, allogeneic, multi-virus specific T-cells, designed to treat or prevent multiple devastating virus-associated diseases. We are now advancing our late-stage clinical trials across our growing product pipeline.

AlloVir is seeking a Head of Drug Safety. Under the general direction of the Senior Vice President of Clinical Research and Safety, the Head of Drug Safety will be responsible for overall clinical risk management and safety surveillance of assigned investigational products. He/She will drive delivery of safety input to clinical development of assets. This includes all aspects of safety data evaluation, including assessing safety from a variety of sources, e.g. clinical trials, literature, and pre- and, in the future, post-approval use. This senior role works closely with Company leadership to implement the evolving direction for the risk management and safety function of the department, as well as leading the effort to develop and align processes to support safety and pharmacovigilance in the post marketing setting.

RESPONSIBILITIES

• Lead and drive safety strategy for the development of assigned products
• Collaborate with appropriate cross-functional company department, and the therapeutic area heads, to ensure efforts are aligned to meet global risk management strategies
• Define the strategic Drug Safety plans and policies including leadership in product safety surveillance strategy and management of evolving safety profile for clinical development programs
• Lead all interactions regarding product safety issues with our governance committees and regulatory agencies
• Provide oversight for the medical review of serious adverse event reports to ensure accuracy, integrity and completeness of safety information, and to ensure consistency of medical coding of safety data.
• Ensure ongoing evaluation of the overall safety profile for AlloVir’s investigational products, serving as the product safety expert, working in partnership with medical monitors to bring potential safety issues to the attention of the Clinical Team and upper management.
• Support Clinical Operations teams with respect to safety related issues as required
• Provide input and review of responses to regulatory agency questions with regard to safety and pharmacovigilance activities.
• Provide support for safety sections of clinical documents, including the review and approval of the safety portion of protocols, annual reports, final study reports, IB, and other documents
• Support the operations of a global function supporting the company pipeline from early Phase development, through BLA/MAA filings, to approval and post marketing
• Coordinate design development and implementation Risk Evaluation and Mitigation Strategies (REMS) among multiple stakeholders
• Advisement on the design of post-approval safety studies
• Develop and align processes to support safety and pharmacovigilance in the post marketing setting

QUALIFICATIONS

REQUIRED

• MD, DO or equivalent
• Minimum 8 years employment working in a clinical practice, clinical research, or product development
• Minimum 4 years’ experience in clinical safety including activities related to post marketing surveillance and pharmacovigilance
• Expert knowledge within global regulatory landscapes
• Direct experience interfacing with relevant global regulatory authorities
• Experience in interpretation of global regulations, guidelines, and reg policy matters
• Ability to thrive in a fast-paced environment
• Strong leader, and team player who demonstrates initiative, willingness to roll-up his/her sleeves, and problem solve
• Strong writing skills is a must, including ability to author documents
• Ability to communicate effectively and represent the Regulatory and Safety organization

 PREFERRED

• Cell and gene therapy experience
• Infectious disease experience
• Board certification in a medical field or medical specialty
• Active US state license to practice medicine or surgery

Why join AlloVir?

AlloVir is the global leader in developing novel cell therapies that restore natural immunity against life-threatening viral diseases for immunocompromised patients.

We have an innovative pipeline of allogeneic, off-the-shelf, T-cell therapies that treat and prevent many devastating and life-threatening viral diseases. Our technology and manufacturing process enables the potential for the treatment and/or prevention of up to six devastating viruses with each single allogeneic cell therapy.

As part of the ElevateBio portfolio of companies, you’ll have access to award-winning facilities with centralized cell and gene therapy manufacturing capabilities that help advance the development of our revolutionary therapies for immunocompromised patients.

Join a team committed to scientific excellence, focused on passionate engagement, and united in purpose to treat and defeat viral diseases.

At AlloVir, we are committed to fostering and expanding diversity in the workplace. We strive to create an environment where everyone feels a sense of belonging and differences are celebrated as strengths. With a company vision of “ImmUnity for all”, we place special emphasis on unity, on equality, and on inclusion for all employees, patients, and partners.

AlloVir 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. AlloVir will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.