Full-Time

Sr. Medical Director

Drug Safety and Pharmacovigilance, Remote

Confirmed live in the last 24 hours

Legend Biotech

Legend Biotech

1,001-5,000 employees

Develops and commercializes cell therapies

Biotechnology
Healthcare

Senior

Remote in USA

Category
Physicians & Surgeons
Medical, Clinical & Veterinary
Requirements
  • MD or MBBS or MD-PhD or equivalent medical degree
  • 5 or more years of pharmaceutical experience in Drug Safety & Pharmacovigilance.
  • Strong understanding of pharmacovigilance regulations in the US and EU.
  • Experience in supporting drug safety activities in registrational clinical studies
  • High level of medical competence, with an ability to balance this with industry standards to achieve business goals
  • Demonstrated skills in scientific analysis and reasoning.
  • Sound knowledge of overall drug development process from discovery to registration and post marketing requirements & surveillance.
  • Prior IND, as well as NDA/BLA (filing/submission) and other regulatory interaction experience is highly desirable
  • Strong track record of delivering results through effective team and peer leadership in matrix
  • Experience as a manager, plan and manage daily activities of team; coaches/mentors/trains team; leads performance management activity (goal setting, performance appraisals, etc.)
  • Excellent leadership & organizational skills, analytical skills, presentation skills, and strong experience in translating important data into clinical strategies.
  • Experience in biotech - preferred but not required.
Responsibilities
  • Lead and support development of pharmacovigilance strategy and activities to ensure compliance with corporate clinical development and commercial goals.
  • Conducting signal detection activities, include monitoring, evaluation, interpretation, management and communication of safety information.
  • Responsible to conduct Safety Monitoring Team (SMT) meeting(s) to evaluate risk-benefit for the compounds with support from cross functional teams. Escalate and present unresolved safety issues to senior management in company governance meetings.
  • Medical safety review including causality assessment of all available safety data generated from various sources (e.g. pre-clinical, clinical trial data, post-marketing and literature) throughout the development process for assigned compounds/projects.
  • Provides medical expert safety review input into all critical documents for products in clinical development (e.g., INDs/NDA/BLA submissions, protocols and amendments, ICFs, IBs, and clinical research reports (CSR))
  • Identification and management of Urgent Safety Measures with support of cross functional team.
  • Overview, and/or author aggregate reports and signal evaluation reports for assigned projects.
  • Responsible for the Clinical content of responses to inquiries from regulatory authorities related to Safety topics.
  • Provide leadership and support to Contract Research Organization (CRO) staff to ensure overall delivery of services. Ensures vendor oversight.
  • Oversee and manage internal safety scientist and safety operation team.
  • Assist with the writing and development of SOPs as required to ensure compliance to regulations and local laws, while maintaining clear instructions for procedures and activities to the achievement of company goals.
  • Lead the development of a significant drug safety budget and effectively manage resources, funding and expenses
  • Lead high quality planning and execution of external meetings and internal stakeholder meetings (e.g., IMs, Governance, DMCs, SSC, Regulatory Authority meetings, etc.)
  • Demonstrated ability to build effective working relationships, influence, negotiate, and drive organizational engagement. Ability to be flexible and adapt quickly to the changing needs of the organization. Work closely with a key strategic alliance partner for projects that are being jointly developed.
  • Identify project risks with input from the cross functional teams, and support resolving issues. Ensure that any potential delays are fully mitigated to avoid any delays with full transparency to senior leadership.
  • Prepare/oversee monthly progress reports and ad-hoc reports as required
  • Support process improvement and functional training at departmental & company level
  • Assure that the highest quality, ethical & professional values are demonstrated in all aspects of the teamwork
  • Ensures compliance with corporate policies and procedures, as well as all related healthcare laws and regulations

Legend Biotech develops and sells cell therapies aimed at treating serious diseases, particularly cancers like hematological malignancies and solid tumors. Their approach is technology agnostic, allowing them to explore various methods to find effective treatments. The company operates in the personalized medicine sector, focusing on discovering, developing, and bringing new therapies to market. They generate revenue through licensing and selling their therapies, including CAR-T therapies, which involve modifying a patient's own cells to combat cancer. Unlike many competitors, Legend Biotech emphasizes transparency with investors, regularly updating them on financial results and business developments. Their goal is to provide effective treatments for hard-to-treat diseases through innovative cell therapy solutions.

Company Stage

IPO

Total Funding

$750.5M

Headquarters

Franklin Township, New Jersey

Founded

2014

Growth & Insights
Headcount

6 month growth

15%

1 year growth

41%

2 year growth

97%
Simplify Jobs

Simplify's Take

What believers are saying

  • Legend Biotech's recent European Commission approval for CARVYKTI® positions it as a leader in the multiple myeloma treatment market.
  • Strategic partnerships, such as the one with MaxCyte, enhance Legend Biotech's capabilities in cell engineering and expand its technological reach.
  • The company's commitment to transparency and investor relations, demonstrated through regular financial updates, fosters investor confidence and long-term stability.

What critics are saying

  • The competitive landscape in cell therapy and personalized medicine is intense, requiring continuous innovation to maintain market position.
  • Regulatory hurdles and the need for extensive clinical trials can delay the commercialization of new therapies, impacting revenue streams.

What makes Legend Biotech unique

  • Legend Biotech's technology-agnostic approach allows it to explore multiple innovative therapies, unlike competitors who may focus on a single technology.
  • The company's comprehensive business model, from discovery to commercialization, ensures control over the entire treatment lifecycle, providing a competitive edge.
  • Legend Biotech's strong focus on CAR-T therapies, particularly for hematological malignancies and solid tumors, sets it apart in the personalized medicine sector.

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