Clinical Development Lead, RHeumatology
vor 4 Monaten
**Working with Us**
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
**Clinical Development Lead (Rheumatology)**
**Position Summary**
The Clinical Development Lead, Rheumatology sits within Clinical Development in ICN, which is a global organization dedicated to the effective design and execution of drug development. Clinical Development drives clinical development strategy, design, execution, and interpretation of clinical trials.
- CDLs are matrix leaders and managers who lead, develop, motivate and achieve results through teams; demonstrate a commitment to the development of a resilient attitude, embrace change and have an unwavering commitment to our People Strategy
- Serves as the clinical point of accountability for the Development Team and is responsible for the overall clinical development plan for asset(s) in one or more indication(s)/tumor type(s)
- Ensures studies are aligned with target label indications and are designed to meet regulatory, quality, medical, and access goals
- Serves as a matrix leader to lead, develop, motivate and achieve results through teams, and is the direct manager to Clinical Trial Physicians (CTPs)
**Key Responsibilities**
- Accountable for the clinical contribution to the development of each indication strategy, including registrational and non-registrational studies, with the support of the CTPs and Clinical Scientists (CS) within the asset and/or indication
- Responsible for managing clinical trial physician(s); attracting, developing and retaining top talent; ensuring appropriate training and mentoring of clinical trial physicians
- May serve as CTP as necessary
- Accountable in partnership with the Clinical Scientist for the design, execution, and analyses of each study led by the CTPs and CSs. Should work to proactively partner with these roles
- Accountable for clinical content for CSRs, regulatory reports, briefing books and submission documents
- Champions a quality-focused mindset and ensures adherence to GCP and compliance obligations for clinical conduct
- Represents Clinical Development in both internal and external forums as the consulted authority for the disease area, including within Business Development function
- Partners with Worldwide Patient Safety physicians in the ongoing review of safety data
- Serves as the (co-)leader of the cross-functional Clinical Development Team
- Provides clinical leadership and disease area expertise into integrated disease area strategies
- Partners closely with KOLs in specific indications
- Serves as Primary Clinical Representative in Regulatory interactions
- Evaluates strategic options against a given Target Product Profile (TPP)
- Collaborates with Global Development Operations/Global Compliance Group to develop asset level risk management plan, resolves issues with Quality/CS, and raises to DT as needed
- Sets executional priorities and partners with CTP and CS to support executional delivery of studies
- Accountable for top line data with support of CTP, CS, and Statisticians
**Qualifications & Experience**
- MD (or equivalent) required with a deep understanding of the clinical principles of the area of interest or equivalent therapy area knowledge
- At least 10 years of overall relevant experience
- Clinical development expertise in the field of Sjogren's disease or related auto-immune conditions is highly desired
- Previous direct report management experience would be preferred
**Experience Requirements**:
CDL has demonstrated leadership in the design and execution of multiple clinical trials (e.g. significant experience as a senior clinical leader), and exhibits all of the following attributes:
- Able to synthesize internal and external data to produce a clinical strategy
- Able to ensure that the clinical program will result in a viable registrational strategy
- Able to assess personnel needs, translate into a hiring strategy, and lead the hiring efforts
- Able to work with other stakeholders to ensure a robust enterprise level strategy for asset(s) and indication(s) including early, late and post-marketing development, as well as awareness of the enterprise disease area portfolio
- CDL has demonstrated, sustained excellent performance as Clinical Trial Physician, Clinical Scientist, or equivalent
- Verifiable track record of successful people management and development, or leadership in a matrix team (e.g. mentoring junior colleagues)
**Key Competency Requirements**:
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