Senior Director, Drug Safety and Pharmacovigilance, Head of Safety | BioNJ Talent Services

Senior Director, Drug Safety and Pharmacovigilance, Head of Safety

Contact Information
Contact Name: 
Amicus Therapeutics
Organization Name: 
Amicus Therapeutics
Position Location: 
Cranbury, NJ
Company Profile: 

COMPANY PROFILE
We are passionate about what we do
Amicus Therapeutics, Inc. (Nasdaq:FOLD) is a global biotechnology company at the forefront of advanced therapies to treat a range of devastating rare and orphan diseases. We have a robust development pipeline of treatments for a range of human genetic diseases.

Our lead product candidate, migalastat, is a personalized medicine in late-stage development to treat individuals with Fabry disease on the basis of their genetic diagnosis. SD-101, a product candidate in late-stage development, is a potential first-to-market therapy for the rare genetic connective tissue disorder Epidermolysis Bullosa (EB). We are leveraging our biologics and Chaperone-Advanced Replacement Therapy (CHARTâ„¢) platform technologies to develop novel enzyme replacement therapy (ERT) products for Fabry disease, Pompe disease, and other Lysosomal Storage Disorders (LSDs). Our lead biologics program is ATB200/AT2221, a uniquely engineered Pompe disease ERT that will be administered in combination with a pharmacological chaperone.

Job Description:

POSITION SUMMARY
This newly created position will report to Vice President, Clinical Research and will be responsible for leading Drug Safety and Pharmacovigilance activities for agents under development, as well as marketed products in Rare Disease. The scope of the position includes safety assessments and surveillance, compliant, timely and complete regulatory authority reporting, benefit-risk assessments, risk identification and mitigation management, and communication of safety information. The individual will be responsible for building the Drug Safety and Pharmacovigilance function at Amicus. The individual will serve as the expert to internal staff across various Departments within the company (Clinical Research, Medical Affairs, Clinical Operations, Regulatory Affairs, Data Management, Statistics, Quality Assurance) leading the provision of key clinical, operational, and strategic input around safety matters, as well as knowledge of a given product's drug safety profile. The individual will ensure effective collaboration across functions, collaborate to advance clinical development programs, deliver post-marketing commitments, oversee the safety profile of proposed independent investigator-sponsored trials, and function as the point person for pre- and post-marketing safety issues. The desirable candidate should be able to oversee and manage the entirety of safety-related projects, as related to the entire research and development process, including protocol development, safety monitoring in clinical trials, preparation and finalization of clinical study reports, regulatory submissions, as well as pharmacovigilance activities for marketed products.

ROLES AND RESPONSIBILITIES
Be responsible for oversight of global drug safety processes and drug safety deliverables
Build the Drug Safety and Pharmacovigilance function at Amicus.
Provide detailed, accurate and timely medical review of aggregate and/or individual clinical trial and post-marketing adverse event reports (AERs)
Medically review individual case study reports from clinical trials, as well as evaluate all relevant cases in depth, including MedDRA coding
Perform regulatory assessment for expectedness and seriousness of AEs
Compose, review and deliver Periodic Adverse Drug Experience Reports
Provide SAE narrative generation; create and maintain internal SAE database; prepare and distribute investigator alerts for clinical trials
Ensure timely and appropriate drug safety contributions to NDA periodic reports
Oversee the regular review of NDA safety data with respect to safety label updates and modifications
Collaborate with Drug Development and Regulatory Affairs to develop Risk Assessment Plan for each development program, with continued monitoring throughout the development and life cycle activities for each program (as well as the compound/ agent level)
Directs the creation and maintenance of company core safety information
Review and approve safety sections of all clinical study reports (CSRs) (including interim as well as final reports)
Oversee the preparation of NDA documents, specifically the Integrated Summary of Safety (ISS) or equivalent document, and all safety related review comments or questions
Develop and oversee Risk Minimization Plan (RMP) and/or Risk Evaluation and Mitigation Strategy (REMS) for all assigned products, as pertinent
Prepare, finalize, and execute safety data exchange agreements
Oversee development, implementation and reporting of pharmacoepidemiology studies - when needed
Review and approve Investigator Brochures (IBs), IND packages, as well as NDA and IND Annual Reports
Review clinical study protocols to ensure adequacy of safety monitoring and analysis, and plans to report such safety information at the time of completion of each trial
Keep informed of new safety regulations and guidance from the regulatory authorities

Qualifications: 

REQUIREMENTS
M.D. degree required with 8-10 years of pharmaceutical Drug Safety and Pharmacovigilance experience in both the pre- and post-marketing settings.
Strong leadership skills, as well as experience working in a matrix environment.
Solid knowledge of general medicine and clinical practice; experience in the rare disease area is preferred.
Must be experienced in safety reviews of IBs, protocols, interim and final clinical study reports, and summaries of safety, both for agents under development, as well as marketed products
Must have strong working knowledge of FDA and EMA regulations/ICH guidelines.
Advanced ability to read, analyze and interpret safety-related scientific and medical literature
Possesses very strong writing skills and advanced verbal communication and presentation skills
Advanced ability to read, analyze and interpret clinical data and information
Requires strong attention to detail in writing and/or proofing materials, as well as in the delivery of internal and external communications
Ability to detect and recognize safety signals and conduct investigations related to safety data
Ability to work in a fast paced environment with demonstrated ability to simultaneously manage multiple competing tasks and demands
Understanding of Risk Management principles as they apply to rare disease drugs in clinical development and on the market
TRAVEL
0-5%

Additional Job or Internship Information
Position Type: 
Full time job
Function: 
Drug Development
Paid: 
Yes