Associate Director/Director Clinical Research

Company: AlloVir
Location: Cambridge
Posted on: April 8, 2021

Job Description:

Associate Director/Director Clinical Research Title: Associate Director/Director Clinical Research Location: Cambridge, MA Reports to: VP, Clinical Research The Role:
We are seeking highly motivated physician-scientists to advance our mission to develop and deliver transformative cell therapies for patients suffering from life-threatening virus-associated diseases. This position will be based in our Cambridge, MA headquarters. The ideal candidate would have a strong clinical background in infectious diseases and/or transplantation medicine (hematopoietic or solid organ), along with some experience in drug development. Our clinical programs include both children and adult patients, reflecting the epidemiology of the diseases we are studying - so either internal medicine or pediatric backgrounds would be suitable. The successful candidate will play a major role in the design and execution of the Company's clinical strategy which encompasses development programs from Phase 1 through product registration world-wide. We seek strong analytical skills, attention to detail, and leadership qualities that will influence our internal team and establish and maintain strong relationships with key external stakeholders.The ideal candidate values bringing important therapies to patients in need, and shares our team's determined, positive attitude. Here's What You'll Do:

• Will be part of a clinical development team responsible for all scientific aspects of conceptualizing, planning and executing trials
• Will be part of a team responsible for the preparation/review of regulatory documents, IND annual reports, IND safety reports, investigator brochures, and development plans, as well as managing the preparation and/or review of data listings, summary tables, study results, study reports, and clinical NDA sections
• Will provide ongoing medical monitoring for clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance (in collaboration with external partners as appropriate)
• Will ensure adherence to regulatory requirements of study conduct (e.g., ICH, FDA) and industry standards of Good Clinical Practice
• Will prepare presentations for scientific conferences as well as for clinical study investigator meetings and expert advisory meetings, and develop manuscripts for publication in peer-reviewed journals
• Will serve as a scientific and clinical resource within Allovir
• Will assist in the clinical evaluation of business development opportunities Requirements:
  • MD or MD/PhD is preferred. Candidates with other doctoral degrees (e.g., PharmD, PhD will be considered if they have relevant experience;
  • Experience in clinical infectious diseases/hematology/oncology/transplantion and/or infectious disease drug development is preferred
  • Relevant industry or academic experience in clinical research with a basic understanding of Good Clinical Practices
  • At least 8+ (10+) years related work experience with a proven success record in clinical research studies and trial design preferred
  • Ability to think analytically and strategically to formulate, develop, and execute clinical plans
  • Strong leadership skills with an ability to set vision, lead change, and mentor others
  • Ability to work effectively in a multidisciplinary team to cultivate an inclusive environment of respectful, open, and honest dialogue and to foster a robust sharing of ideas and creative problem solving
  • Experienced with engaging experts in constructive scientific and clinical dialog around clinical strategy, study design, study conduct, and interpretation of clinical results
  • Strong sense of integrity and work ethic, scrupulous attention to detail, clear ability to establish and maintain timelines, and persistent commitment to ensuring a high level of quality
  • Excellent oral and written communication skills; Strong presentation skills and the ability to communicate complex scientific concepts to a broad audience
  • Outstanding problem solving, troubleshooting and organization skills
  • Proficient with computers and software such as Microsoft Office, and other relevant software
  • Both an effective team player and a strong individual contributor. Needs to be flexible, and able to handle multiple tasks and deliver high quality results under tight timelines
  • Ability to travel domestically and internationally to company, scientific/medical, regulatory, investigator, and other meetings (-20-30% travel expected) 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 in order 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'll 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: AlloVir, Cambridge , Associate Director/Director Clinical Research, Healthcare , Cambridge, Massachusetts