CambridgeRecruiter Since 2001
the smart solution for Cambridge jobs

AlloVir - Head of Drug Safety

Company: ElevateBio
Location: Cambridge
Posted on: September 17, 2020

Job Description:

Reports to: Chief Regulatory & Safety Officer

The Role

At AlloVir (formerly ViraCyte) 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. AlloVir has built an innovative technology platform developed by researchers at Baylor College of Medicine’s Center for Cell and Gene Therapy. 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 planning and advancing mid- and late-stage clinical trials across our growing product pipeline.

AlloVir is seeking a Head of Drug Safety . Under the general direction of the Chief Regulatory and Safety Officer, the Head of Drug Safety will be responsible for overall clinical risk management and safety surveillance of assigned investigational products. Additionally, the incumbent will provide senior safety leadership for our Company pipeline and 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 helping to develop and align processes to support departmental objectives.

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

Lead all interactions regarding product safety issues with our governance committees and regulatory agencies

Ensure completeness of safety information in company-wide core safety documents

Define the strategic Drug Safety plans and policies

Lead product safety surveillance strategy and management of evolving safety profile for clinical development programs

Support the operations of a global function supporting the company pipeline from early Phase development, through BLA/MAA filings, to approval and post-marketing

Create/update the safety/risk section in protocols, investigator brochures, and informed consent forms

Analysis strategy for Integrated Summary of Safety (ISS) and benefit-risk content within the Clinical Overview documents associated with regulatory filings

Coordinate design development and implementation Risk Evaluation and Mitigation Strategies (REMS) among multiple stakeholders

Advisement on the design of post-approval safety studies

Facilitate cross-functional collaboration within the organization to ensure proper safety standards are met and communicated

Responsible for medical-safety sections of aggregate safety reports (e.g. DSUR, PSUR)

Assisting in the successful implementation, execution and maintenance of safety processes and systems that conform to the company’s business strategy, industry standards and comply with global regulations

Provide medical safety expertise for monitoring of clinical trials and data and safety monitoring boards

Support Safety Operations to establish and maintain policies and procedures

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

Active participant of the global Regulatory Affairs & Safety Leadership Team

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

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

Join the leader in the development of novel cell therapies with a focus on restoring natural immunity against life-threatening virus-associated diseases in patients with severely weakened immune systems. Over many years, AlloVir’s world-leading scientists have developed a highly innovative pipeline of allogeneic, off-the-shelf, T-cell therapies being studied to treat and prevent many devastating and life-threatening virus-associated diseases. The company’s lead product, Viralym-M, an investigational cell therapy to treat active virus-associated diseases, including from BK hemorrhagic cystitis, cytomegalovirus, adenovirus, Epstein-Barr virus, JC virus and human herpesvirus 6. AlloVir’s 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.

Join AlloVir to help advance the development of this innovative technology platform and multiple mid- and late-stage clinical trials to help severely immunocompromised patients. AlloVir is part of the ElevateBio-family of companies with access to ElevateBio BaseCamp’s industry-leading, centralized cell and gene therapy manufacturing capabilities. By joining AlloVir, you will be able to not only advance innovative science but also a part of a truly new business model for advancing cell and gene therapies.

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

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.

Keywords: ElevateBio, Cambridge , AlloVir - Head of Drug Safety, Other , Cambridge, Massachusetts

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


Sales – Training Offered
Description: If you re exploring sales careers, you already know sales is the way to get ahead. You can sell just about anywhere, but the key is knowing how to spot the right opportunity. Have you ever noticed (more...)
Company: Platinum
Location: Woonsocket
Posted on: 09/26/2020

Amazon Warehousing Worker (With $500 Sign-on Bonus) - Earn up to $18.75/hr
Description: Shifts: Overnight, Early Morning, Day, Evening, Weekend Location: Northborough, MA Job opportunities vary by location. We update postings daily with open positions. Hourly pay rate: Earn (more...)
Company: Amazon
Location: Woonsocket
Posted on: 09/26/2020

Amazon Warehousing Worker (Multiple Shifts Available)
Description: Shifts: Overnight, Early Morning, Day, Evening, Weekend Location: Northborough, MA Job opportunities vary by location. We update postings daily with open positions. Hourly pay rate: Earn (more...)
Company: Amazon
Location: Woonsocket
Posted on: 09/26/2020


Amazon Warehousing Worker (Multiple Shifts Available)
Description: Shifts: Overnight, Early Morning, Day, Evening, Weekend Location: Northborough, MA Job opportunities vary by location. We update postings daily with open positions. Hourly pay rate: Earn (more...)
Company: Amazon
Location: Woonsocket
Posted on: 09/26/2020

Amazon Workforce Staffing: Sort Center - Flexible Schedule - $18. 25/Hr
Description: Full-time Warehouse Team Member 500 sign-on bonusHourly pay rate:Earn 15.75 18.75/hr, plus benefits and a 500 sign-on bonus. Limited-Time OpportunityLocation:Taunton, MAJob opportunities vary by (more...)
Company: Amazon Workforce Staffing
Location: Woonsocket
Posted on: 09/26/2020

Aflac Regional Office: Insurance Representative - Attleboro, Ma
Description: Quick Facts:Insurance Sales New and existing Clients Leadership Positions AvailableHours: Monday Friday 8-5 Client and Customer facing roleActively Interviewing during COVID-19Virtual and in-person (more...)
Company: Aflac Regional Office
Location: Woonsocket
Posted on: 09/26/2020

Warehouse Attendant - Earn up to $18.25/hr plus benefits and a $1000 sign-onbonus
Description: Seasonal Full-time Warehouse Team Member - 1000 sign-on bonus Hourly pay rate: Earn 15.25 - 18.25/hr, plus benefits and a 1,000 sign-on bonus. Limited-Time Opportunity Location: Milford, (more...)
Company: Amazon
Location: Woonsocket
Posted on: 09/26/2020

Amazon Warehouse Operator (With $250 Sign-on Bonus) - Earn up to $18.75/hr
Description: Shifts: Overnight, Early Morning, Day, Evening, Weekend Location: Northborough, MA Job opportunities vary by location. We update postings daily with open positions. Hourly pay rate: Earn (more...)
Company: Amazon
Location: Woonsocket
Posted on: 09/26/2020

Licensed Life Insurance Independent Contractor - Work from Home
Description: Licensed Life Insurance Independent Contractor - Work from Home We got what you want, you got what we need Are you a Licensed Insurance Agent looking for a flexible opportunity One where you're (more...)
Company: LiveOps
Location: Woonsocket
Posted on: 09/26/2020

Warehouse Handler (Full-Time)
Description: Shifts: Overnight, Early Morning, Day, Evening, Weekend Location: Northborough, MA Job opportunities vary by location. We update postings daily with open positions. Hourly pay rate: Earn (more...)
Company: Amazon
Location: Woonsocket
Posted on: 09/26/2020

Log In or Create An Account

Get the latest Massachusetts jobs by following @recnetMA on Twitter!

Cambridge RSS job feeds