Senior Director of Pharmacoepidemiology

Company: Jazz Pharma
Location: Palo Alto
Posted on: April 10, 2021

Job Description:

Overview:Jazz Pharmaceuticals is a global biopharmaceutical company dedicated to developing life-changing medicines for people with serious diseases - often with limited or no options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in key therapeutic areas. Our focus is in neuroscience, including sleep medicine and movement disorders, and in oncology, including hematologic and solid tumors. We actively explore new options for patients including novel compounds, small molecule advancements, biologics and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in more than 90 countries.We are looking for the best and brightest talent to join our team. If you're looking to be a part of a company with an unwavering commitment to improving patients' lives and being a great place to work, we hope you'll explore our career openings and get to know Jazz Pharmaceuticals.Responsibilities:The Head of Pharmaco-epidemiology for Jazz Pharmaceuticals Medical Safety Department will assume responsibility for the leadership of the pharmacoepidemiology team, and for integrating this function within Jazz pharmaceuticals, aligned with compliance and regulatory guidelines. This role will also have significant role in the strategy and management of benefit/ risk profile and evaluation of multiple development compounds and/or marketed medicines, in collaboration with other medical safety and PV teams, as well as cross-functional teams, such as clinical development, medical affairs, regulatory, etc.He/She will be responsible for planning, implementing and delivering high quality, scientifically robust observational research projects which support drug development programs, regulatory submissions and post marketing safety and effectiveness. Key Responsibilities:

• Manage the growing team of pharmaco-epidemiologists within Jazz Pharmaceuticals.
• Maintain and expand an epidemiology support strategy aligned to the drug development strategy and aimed to improve disease understanding relevant to drug development: incidence, prevalence, risk factors, natural history course, treatment patterns, co-morbidities, co-medications, outcome measures, phenotypes, biomarkers, unmet needs, and their variations across domains such as demographics and geographies.
• Support and be accountable to advise scientifically on Real World Evidence strategies
• Contribute to medication safety evaluation: provide background event rates, synthesize existing evidence including through meta-analyses, and identify high-risk populations.
• Propose and lead post-marketing activities: risk evaluation mitigation strategies, epidemiology studies for signal detection and inference, post-authorization studies of treatment benefit and risk.
• Critically appraise existing epidemiology evidence and create new evidence through delivery of specific research plans/protocols and analysis of healthcare databases
• Develop strong partnerships with internal stakeholders in a multi-disciplinary framework (clinical, safety, regulatory, health outcomes, and asset leadership) to meet product needs.
• Plan resource allocation to accomplish multiple research projects, and attain project and study timelines.
• Identify innovative, timely and cost effective methods to conduct epidemiologic studies.
• Negotiate internal funding of projects.
• Develop and negotiate research plans with external collaborators in academia or contract research organizations and work effectively with vendors for outsourced studies.
• Communicate study findings to relevant internal and external audiences effectively.
• Input into regulatory submission documents and represent the function to regulatory agencies as required
• Present the company position on epidemiology issues and epidemiology findings to regulatory agencies and other external authorities.
• Extend a track record of external publications in peer reviewed journals in support of asset teams.
• Strengthen the position of the newly created Benefit-Risk and Epidemiology group within Jazz Pharmaceuticals
• Required Education and Qualifications:The ideal candidate will possess a combination of academic training and practical experience in pharmaco-epidemiology. Candidates must possess one of the following to be considered:
  • At least 5-6 years of experience in the pharmaceutical industry in epidemiology, pharmacoepidemiology, observational studies (prospective studies, patient registries, retrospective database studies) real-world evidence (RWE) generation, risk management, quantitative benefit risk assessment and methodology for safety monitoring in clinical trials.
  • Proven leadership in PASS studies, signal detection methodology in pharmacovigilance and clinical trials.
  • Managerial responsibilities leading pharmaco-epidemiology teams within pharmaceutical industry
  • Doctoral degree (PhD, ScD or DrPH or equivalent) in epidemiology with a minimum of 5 years' industry experience (will be given preference), OR
  • Doctoral degree (PhD, ScD or DrPH or equivalent) in another relevant field (i.e. health services research, health outcomes research, public health, statistics or pharmaceutical sciences), with a minimum of 5 years' industry pharmacoepidemiology experience, OR
  • Clinical Advanced degree (MD, PharmD, or equivalent) and a Master's degree in Epidemiology with a minimum 5 years' experience leading pharmaco-epidemiologic research in a drug development environment.
    • Demonstrable experience leading pharmaco-epidemiologic research programs in a drug development environment.
    • Excellent oral and written communication skills and demonstrated ability to communicate scientific evidence to peers and at scientific meetings. Preferred Qualifications:
      • Expertise in neuroscience, particularly sleep epidemiology
      • Expertise in cancer epidemiology
      • Self-motivated with the ability to work with minimal supervision to develop credibility with colleagues within and outside Epidemiology, as well as interact effectively in multi-disciplinary matrix teams to influence decisions
      • Broad experience in collaborating with research partners
      • Ability to demonstrate strategic thinking and problem resolution to fill evidence gaps
      • Ability to work well within a business-driven environment, balance priorities and handle multiple tasks through careful planning, stakeholder management, project administration, and organizational skills
      • Record of high-quality, peer-reviewed epidemiology and/or outcomes research publications and/or demonstrated leadership in external scientific societies/industry-wide collaboration
      • Individuals with experience in leading epidemiology research in US and EU, particularly using RWD data including pregnancy registries Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

Keywords: Jazz Pharma, Palo Alto , Senior Director of Pharmacoepidemiology, Executive , Palo Alto, California