What are the responsibilities and job description for the Director, RWE Strategy, Rare Diseases position at Chiesi?
About us
Based in Parma, Italy, Chiesi is an international research-focused pharmaceuticals and healthcare group with over 85 years' experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people's quality of life by acting responsibly towards society and the environment, the Group research, develops and markets innovative drugs in its three therapeutic areas: AIR (products and services that promote respiration, from new-born to adult populations), RARE (treatment for patients with rare and ultra-rare diseases) and CARE (products and services that support special care and consumer-facing self-care).
We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes transparent ethical behavior at all levels.
We are committed to embrace diversity, inclusion and equal opportunities. In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.
Chiesi USA
Chiesi USA is a specialty pharmaceutical company focused on developing and promoting products for the hospital, adjacent specialty and rare disease markets. We are a B Corp and Benefit company awarded Top Employer status for six consecutive years and certified as a Great Place to Work.
At Chiesi, we share an entrepreneurial spirit and act as a force for good, pursuing high social and environmental standards, to ensure the wellbeing of our people, patients, and communities. We offer a work environment where professionals have the opportunity to build a purposeful career focused on helping others while achieving a fulfilling work-life balance, meeting exciting challenges, and engaging in important and rewarding work.
What we offer
Chiesi offers competitive benefits, services, and programs that enrich the personal and professional lives of our employees. Our shared values of passion, innovation, trust and integrity bring out the individual talents and diverse perspectives of each of our colleagues. Our environment encourages each individual to reach his or her full potential and drive outstanding results. We celebrate that "Every one of us is different. Every one of us is Chiesi."
The Director of Global RWE Strategy will develop strategic roadmaps with cross-functional teams and use tactical plans to identify key RWD external partnership opportunities. The incumbent will oversee data procurement activities (e.g., landscape assessments and due diligence or supporting contract development for external studies). This role requires meaningful experience in pharmaceutical drug development and knowledge of sophisticated analytics, bringing to bear diverse data domains and using artificial intelligence and machine learning to optimize programs across development. This includes novel use of real-world data and evidence to shape regulatory and payer discussions, and drive efficiencies in clinical program. This role will report to the Head of HEOR & RWE, Rare Diseases Business Unit.
Provide scientific guidance on the application of Real World Evidence and observational research data to address issues across the Rare Diseases business units
* Provide technical input, options and direction to strategic decisions made by Chiesi Global Rare Disease on study design, data partner selection and best practice in RW data utilization
* Provide clear technical input, options, and direction to strategic decision on RWE platform and capability build
* Assist in building capability that becomes a source of sustained competitive advantage for Chiesi GRD in identifying, acquiring, integrating, and mining diverse RW data from multiple geographic and healthcare system sources to support evidence generation and real-world studies
* Evaluate and assess strengths and weaknesses of external RW data sources, and potential partner for advancing the data strategy for specific therapeutic areas
* Maintain a strong insight into the capabilities of potential external partner in RWD/E, especially for US and EU/EM.
* Maintain awareness of scientific developments, new and innovative methodologies, and trends in the evolving healthcare landscape to ensure incorporation into HEOR and medical strategy and research plans.
* Rotating member of non-interventional study protocol review groups
* Strategic and tactical support for cross-functional RWE development including registries, burden of illness/natural history of disease for regulators, payers and clinicians.
The Global RWE Strategy, Director will also be expected to:
* Demonstrated expertise in data mining approaches within healthcare settings generating insights from routinely collected healthcare data
* Develop effective processes and ways of working to support collaboration with key internal stakeholder groups (e.g. medical, clinical development, commercial, etc.)
* Demonstrated ability to build long-term relationships with collaborators at senior level, understand relevant scientific/business challenges at a deep level and translate into a program of informatics activities to deliver defined value
* Ability to lead & manage multi-disciplinary data science projects
* Strong track record of delivering large, cross functional projects
* Experience in working in a global organization and delivering global solutions
* Use of Machine Learning and Artificial Intelligence in the generation of hypotheses within Real World Data
7 plus years of experience in real-world evidence and familiarity with health economics/epidemiology, and quantitative science such as health outcome modelling
* Expertise in EMR/Health IT, disease registries and insurance claims databases
* Expertise in clinical data standards, medical terminologies and controlled vocabularies used in healthcare data and ontologies (ICD9/10/ReadCode)
* Experience in Statistical Analysis Plan (SAP) generation and execution for observational studies
* Expertise in methods development and application using statistical languages such as R/Matlab/SAS/SQL/Hadoop/Phyton
* Experience in advanced visualization and visual analytics of routinely collected healthcare data
* Demonstrated ability to manage multiple projects involving complex process, significant budget, competing deadlines, and rapidly shifting priorities in a compliant manner
* Excellent oral and written English communication skills
* Knowledge and experience in Rare Diseases is strongly preferred
* Ability to travel domestically and internationally
* PhD or MS in data science or other advance degree in life science with post-doctoral or other training/work in Medical or Health Informatics or related field
Chiesi USA is an equal opportunity employer committed to hiring a diverse work force at all levels of our business. All qualified applicants receive consideration for employment without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, veteran status, gender identity or expression or any other basis protected by local, state or federal law. This policy applies with regard to all aspects of one's employment, including hiring, transfer, promotion, compensation, eligibility for benefits and termination.
