Medical Director Safety and Pharmacovigilance

Adaptimmune

Abingdon, GB / Oxfordshire, GB
  • Job Type: Full-Time
  • Function: Regulatory Affairs
  • Post Date: 04/30/2021
  • Website: adaptimmune.com
  • Company Address: 351 Rouse Boulevard , Philadelphia, PA , 19112

About Adaptimmune

Adaptimmune, a leader in T-cell therapy, is a multinational, clinical-stage biopharmaceutical company focused on developing novel immunotherapies using its proprietary SPEAR T-cell receptor platform to treat solid tumors, which has the potential to transform the treatment of cancer.

Job Description

The Medical Director of Pharmacovigilance is responsible for leading the analysis of emerging clinical safety data, while developing safety strategies for Adaptimmune.  They will be accountable for ensuring effective pharmacovigilance practices and the quality of all drug safety programs and drug safety deliverables. This will include:

  • Directing responsibility for safety surveillance activities, adverse event assessment and reporting, leading safety review teams and other safety meetings, and otherwise providing pharmacovigilance scientific support and guidance across the Adaptimmune organization
  • Leading the medical assessments of all adverse event findings, including those requiring submission to regulatory authorities
  • Driving short-term and long-term strategic planning for the development of the Safety and Pharmacovigilance Department
  • Contributing to the implementation and maintenance of Pharmacovigilance Systems (procedures, training, databases etc.)
  • Prepare safety related regulatory documents and participate in IND, BLA filings

This a global role that will work closely with members of the U.S. and U.K. clinical strategy and development teams, preclinical safety, regulatory, clinical operations and compliance.

RESPONSIBILITIES

  • Overall responsibility in ensuring the patient safety during the clinical trial
  • Oversee all aspects of drug safety surveillance including review of adverse event data, literature, and other Safety-relevant data for the purpose of signal detection and evaluation
  • Review study progress and collate emerging patient data in the Company’s clinical trials and long-term safety studies into summary reports for regulatory submissions, publications, and KOL/investigator meetings
  • Contribute to overall benefit-risk evaluations including presentations to the Global Safety Board, and preparation for any applicable regulatory obligations
  • Management of Pharmacovigilance systems (safety procedures, pharmacovigilance training, safety databases, Pharmacovigilance master file)
  • Lead safety review meetings
  • Direct the medical assessments of all adverse event findings, including those requiring submission to regulatory authorities, including but not limited to individual case safety reports (ICSRs), IND Safety Reports, INDs, NDAs, annual report summary statements, and Periodic or Developmental Safety Update Reports (PSURs/DSURs).
  • Ensure subject safety in drug development activities in compliance with regulatory requirements and company standard operating procedures
  • Drive core safety information updates and initiatives based on data from signal detection, clinical practice, or scientific research.
  • Keep abreast of new safety regulations and guidance from the regulatory authorities
  • Provide leadership and guidance during internal and external safety audits
  • Oversee and guide remediation of any Pharmacovigilance deficiencies cited during regulatory or internal audits
  • Prepare and review safety section of IBs, Protocols, Informed Consent, adverse event CRF pages, Clinical Reports, and IND/NDA/other regulatory submissions
  • Organize and manage Safety Review Committee meetings and other interactions with external safety experts
  • Contribute in the development and provide safety contents for risk management plans
  • Lead authorship and provide content for periodic safety reports; e.g., development safety update report (DSURs)
  • Contribute to implementation of safety related Corrective Action and Preventive Action (CAPA) for assigned products
  • Establish and maintain policies and procedures and training for Pharmacovigilance
  • Participate in interactions with investigators and site staff ensuring the effective exchange of emerging clinical and safety data. This may include periodic site visits, collaboration with clinical operations colleagues, site training on adverse event reporting, and participate in face to face meetings at relevant conferences  
  • Occasional domestic and international travel is expected

REQUIREMENTS

  • MD degree required
  • Industry pharmacovigilance experience, preferably including oncology and/or immunology
  • Experience with biologics or cell and gene therapy is helpful but not required
  • Strong knowledge of pharmacovigilance regulatory process (FDA and EMA) is required, preferably including risk management plans and REMS
  • Prior experience with safety databases
  • Proven experience independently running/managing at least one clinical/pharmacology project, preferably in oncology or immunology
  • Ability to work flexibly and take on new tasks in a small company environment
  • Strong interpersonal and communication skills (both spoken and written)
  • Experience collaborating across departments and with senior leaders and external experts
  • Trained in and knowledgeable regarding Good Clinical Practices, Protection of Human Subjects, HIPAA, and Pharmacovigilance.

 

At Adaptimmune we embrace diversity and equality of opportunity. We believe that the more inclusive we are, the better our work will be. We welcome applications to join our team from all qualified candidates, regardless of age, colour, disability, marital status, national origin, race, religion, gender, sexual orientation, gender identity, veteran status or other legally protected category. It is our intent that all qualified applicants will receive equal consideration for employment.

Related Jobs

Manufacturing Cell Therapy Specialist I

Adaptimmune - Philadelphia, PA, US

Director/Senior Director of Facilities UK - Stevenage / Abingdon

Adaptimmune - Stevenage, GB

Associate Director SAS Programmer

Adaptimmune - Philadelphia, PA, US

Principal SAS Programmer/Data Scientist

Adaptimmune - Philadelphia, PA, US

Sr. Director, Information Security

Adaptimmune - Philadelphia, PA, US
Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.