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Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
The Head of Patient Experience will work in strong, proactive collaboration with Global Pricing and Market Access, Regulatory Affairs, Global Drug Safety and Risk Management, as well as the Therapeutic Areas in Global Clinical Research & Development (GCR&D) to increase the probability that pivotal trials will result in full regulatory approval and reimbursement globally through improved and innovative assessment of the patient experience with the disease and its treatment. He/she will support differentiation of Celgene products from competitors in the marketplace by credible documentation of effects of new medicines on the patient experience. He/she will select existing or develop new clinical outcome assessments to document the patient experience, including patient reported outcomes, that are rigorously developed, sensitive to treatment effects, and interpretable by global stakeholders and develop innovative technology and interactive approaches to achieve this. He/she will identify unmet patient needs that can be targeted with new or existing treatments.
- Build and lead the GCR&D patient experience team in supporting decisions regarding selection, administration, and analysis of patient-reported outcome (PRO) instruments to be used in clinical trials to assess efficacy and tolerability endpoints
- Improve the implementation, the data collection (completeness and quality) and the data analysis of PRO in GCR&D clinical trials
- Collaborate with Drug Safety on the assessment of PROs to assess adverse effects
- Develop new instruments and new technology to collect these measures
- Support GCR&D, Regulatory Affairs, and Drug Safety and GPMA line functions in developing endpoint strategies for use in pre- and post-approval trials and observational studies as well as in “big data” approaches with Celgene’s IKU group
- Actively participate in the development of regulatory submissions and payer documentation regarding patient experiences and attend meetings with key regulatory and payer stakeholders
- Lead initiatives to develop new clinical outcome assessment instruments when needed
- In collaboration with Celgene’s Patient Advocacy Group, the GCR&D TA Heads and other internal partners establish and maintain a meaningful dialogue with Patient Advocacy Groups about Celgene’s clinical development program
- Identify novel methods to examine the patient experience, including the use of patient-reported and wearable technology to capture clinical outcome assessments
- Establish Celgene thought leadership in patient experience area through publications and presentations at scientific and patient advocacy conferences
The Head of Patient Experience must have a research-oriented academic life-sciences background (i.e. Psychology), ideally with a Ph.D. (or similar advanced degree) in a related subject and with over 10 years of pharmaceutical or biotech experience in research with patient-reported outcomes.
The ideal candidate would have:
- A solid background in
- The selection of existing and the development of new patient-reported outcome measures for drug-development programs
- The integration patient-reported outcome measures into pharmaceutical trials and the collection of high-quality data from these measures.
- The statistical analysis and the reporting of data from patient-reported outcome measures
- Strong regulatory experience with the FDA and EMA.
- A thorough understanding of how all clinical development functions come together to support global registration programs
- A thorough understanding of the drug commercialization process and how clinical development can optimally support future commercialization
- Enthusiasm and passion and must distribute this enthusiasm and passion to their groups
- Excellent verbal written and public speaking skills
- A strong business sense
- Strong Leadership skills
- Demonstrated ability to build and manage both internal and external relationships
- Demonstrated ability to manage and lead cross-functional teams to timely go/no-go decisions, and observing budget-limitations
- Vision and the ability to implement that vision
- Demonstrated ability to make sound decisions
- Approachability Must be comfortable with change and be an agent of change
- Must be able to manage in a matrix
- Must be able to build strong bridges throughout the company and use influence without authority
- Must be able to think strategically and communicate clearly
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.