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Form of workThe Associate Director/Director, a member of Shionogi's Global Epidemiology and Real-World Evidence (GEE) team, is responsible for strategizing and generating real-world evidence using fit-for-purpose data to support global products at each stage of the product lifecycle.
This position will report to the Executive/Senior Director, GEE and support strategy, execution and communication of real-world evidence (RWE) and epidemiology tactics for both pipeline and launch products.
This role will also work closely with global and regional (Osaka, Japan [SHQ]; Florham Park, New Jersey [SI]; and London, England [SEU/SBV]) cross-functional team members including Medical Affairs, HEOR, Clinical Development, Regulatory, Market Access, Commercial teams and external collaborators/vendors to lead and conceptualize research questions, propose study designs, identify appropriate databases, write and review protocols, oversee data analyses, reports, presentations, and publications. The position will also develop and adopt innovative methodologies to advance our real-world observational and pharmacoepidemiologic research. Budgetary oversight responsibilities for specific activities may be required.
The role requires strong expertise and experience in scientific methods and operational efficiency to independently execute real-world and epidemiology studies. In addition, possess a strong scientific acumen and strategic thinking to drive RWE and epidemiology activities. Demonstrated creativity, complex data mining capabilities, and solution-driven aptitude are necessary capabilities for the role. Effective presentation and communication skills are necessary.
RESPONSIBILITIES
The following job duties are not all-inclusive and additional responsibilities may be added to the role as needed.
- Lead the development and execution of integrated evidence plans for the assigned products.
- Able to work in multi-matrix environment and represent GEE in cross-functional meetings and initiatives.
- Design and conduct observational studies using either primary or secondary data.
- Robust knowledge and experience of studies using claims data, electronic health records, targeted or systematic literature reviews, survey methods, registry data, chart reviews, qualitative data etc.
- Oversee and assist the operational process of observational studies that collect the data from the study sites by tracking the project activities (for example study contract, IRB, monitoring, and site communication).
- Be able to lead the research and implement innovative methods to generate data.
- Support the identification of fit-for-purpose healthcare databases and/or suitable vendors in different countries for assigned projects.
- Work with key opinion leaders on RWE/Epidemiology studies.
- Proactively lead the development of concepts/protocol/study analysis plans and reports based on research needs and strategy.
- Supervise and evaluate the analyses performed by analysts or vendors to ensure the accuracy and efficiency of deliverables. Perform statistical analyses, as needed, with good documentation and good quality.
- Author study reports or publications (e.g. scientific manuscripts, abstracts, posters, internal and external presentations) and make presentations to support the product pre and post its regulatory approval.
- Identify appropriate target journals/conferences for publications and work with cross-functional teams on appropriate ways of data dissemination.
- Contribute to the development and review of clinical trial protocols, value dossier and product forecasting.
- Provide necessary input into project team budget planning of the real-world evidence activities for assigned products; have budget oversight for specific epidemiology activities.
- Provide epidemiologic support and input into risk management plans and Periodic Safety Update Reports and safety evaluations.
SUPERVISORY | DECISION-MAKING AUTHORITY
- Responsible for managing analysts and/or vendor relations.
- Responsible for developing and executing RWE strategies and timelines for the assigned products.
- Lead the RWE study team.
- Will be responsible for managing timelines, contracts and deliverables with vendors.
MINIMUM JOB REQUIREMENTS
- Advanced degree MSc/MD/PhD with a degree in epidemiology or related field is preferred.
- Minimum of 5 plus years of relevant experience in generating RWE/epidemiology research to support pharmaceutical product life cycles in the biotech or pharmaceutical industry.
- Must be flexible to work in a hybrid work environment. Able to commute to US Corporate offices in Florham Park, NJ 2-3 days a week.
- The role will be hired at the level commensurate with experience.
PREFERRED SKILLS & EXPERIENCE
- Strong knowledge and experience of epidemiological study designs, including understanding of observational and epidemiological endpoints, assessments and data interpretation.
- Understanding of good practices, compliance and ethical considerations in conducting real-world and epidemiology research.
- Proven team-working successes - demonstrated leadership, follow-through, and stakeholder management skills.
- Good knowledge of drug development, life-cycle management and regulatory guidelines.
- Up-to-date knowledge of the current RWD/RWE trend, healthcare policies and relevant RWD/RWE guidance/frameworks.
- Able to develop relationships with relevant organizations including ISPOR, ISPE, AMCP etc. and build institutional knowledge on RWE and epidemiology.
- Ability to proactively identify opportunities and needs for RWE for assigned products.
- Strong statistical background and knowledge of statistical programming. Experience in working with programmers/analysts.
- Strong analytical and critical thinking to proactively and independently lead global and regional real-world studies.
- Good written and verbal communication skills. Experience in communicating with all levels of personnel across various departments, in domestic and international environments.
- Good project management skills including experience in prioritizing and managing multiple tasks and timelines concurrently.
- Ability to work independently in high-pressure environments.
- Experience in conducting various observational studies for different purposes including those to support regulatory (e.g. external trial arm, label expansion etc.) and payor decisions.
ESSENTIAL PHYSICAL REQUIREMENTS
- Ability to articulate clearly and conduct verbal presentations with large and small audiences.
- Ability to travel via automobile and/or airplane.
- Ability to view video display terminal images < 18" away from face for extended period of time - up to four (4) hours at a time.
- Ability to operate a computer keyboard and telephone.
- Ability to sit for extended periods of time - up to four (4) hours at a time.
- Ability to lift, tug, pull up to fifteen (15) pounds.
To be considered for this position, you must apply and meet the requirements of this opportunity.
We look forward to reviewing your resume & qualifications.
DISCLAIMER
The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilitiesmay change or be assigned at any time with or without notice.
EEO
Shionogi Inc. is an equal opportunity/affirmative action employer.
All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law.
It is the policy of Shionogi Inc. to undertake affirmative action in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
