Bristol-Myers Squibb
Clinical Development Lead, Rheumatology
Bristol-Myers Squibb, Winter Garden, Florida, us, 34777
Overview
Join to apply for the
Clinical Development Lead, Rheumatology
role at
Bristol Myers Squibb Working with Us Challenging. Meaningful. Life-changing. Those words describe more than a typical job at Bristol Myers Squibb. You will be part of a global environment where important work happens every day, across departments, from optimizing processes to breakthroughs in cell therapy, transforming patients lives and career paths. Bristol Myers Squibb values balance and flexibility, offering competitive benefits and programs to support employees in work and personal goals. Read more: careers.bms.com/working-with-us. Position Summary / Objective
The Clinical Development Lead sits within Clinical Development, a global organization dedicated to the effective design and execution of drug development. The team drives clinical development strategy, design, execution, and interpretation of clinical trials. Responsibilities
Serve as the clinical point of accountability for the Development Team and the overall clinical development plan for asset(s) in one or more indication(s)/tumor type(s). Ensure studies are aligned with target label indications and designed to meet regulatory, quality, medical, and access goals. Act as a matrix leader to lead, develop, motivate and achieve results through teams, and serve as direct manager to Clinical Trial Physicians (CTPs). Accountable for the clinical contribution to the development of each indication strategy, including registrational and non-registrational studies, with support from CTPs and Clinical Scientists. 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. Partner with Clinical Scientist for design, execution, and analyses of each study; proactively collaborate with CTPs and CSs. Accountable for clinical content for CSRs, regulatory reports, briefing books and submission documents; champion a quality-focused mindset and ensure adherence to GCP and compliance obligations. Represent Clinical Development in internal and external forums as the consulted authority for the disease area; partner with Worldwide Patient Safety physicians on safety data reviews. Serve as (co-)leader of the cross-functional Clinical Development Team; provide clinical leadership and disease area expertise into integrated strategies; partner with KOLs in specific indications. Serve as Primary Clinical Representative in Regulatory interactions; evaluate strategic options against the Target Product Profile (TPP). Collaborate with Global Development Operations/Global Compliance to develop asset-level risk management plans, resolve issues with Quality/CS, and escalate to DT as needed. Set executional priorities; partner with CTP and CS to support delivery of studies; accountable for top line data with support of CTP, CS, and Statisticians.
Qualifications
MD preferably with appropriate sub-specialty training; PhD, Pharm D or other health-related field with deep understanding of the clinical principles in the area, or equivalent therapy area knowledge. At least 9 years of relevant experience.
Experience & Competencies
Leadership in the design and execution of multiple clinical trials; ability to synthesize data to formulate clinical strategy and ensure a viable registrational strategy. Experience in personnel needs assessment, hiring strategy, and leading hiring efforts; ability to partner for enterprise-level asset/indication strategy across early, late, and post-marketing development. Proven leadership as Clinical Trial Physician, Clinical Scientist, or equivalent with a track record of people management. Ability to lead a group of CTPs to ensure scientific and technical excellence of development programs and deliverables. Strong skills in clinical development strategy, regulatory submission components, external relationship building with key opinion leaders and collaborators outside of BMS. Ability to collaborate with Early Development teams to ensure seamless transition into late-stage development.
Travel
Domestic and International travel may be required. Compensation & Benefits
The starting compensation for this job is a range from $313,200-379,500 plus incentive cash and stock opportunities (based on eligibility). Final compensation is determined based on demonstrated experience. Benefits vary by location and role. For more on benefits, visit the career site. Legal & Workplace Information
BMS is committed to equal employment opportunity and providing accommodations in recruitment. If you require reasonable accommodations, contact adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility for the EEO statement. Covid-19 vaccination is encouraged for employee well-being. BMS may consider applicants with arrest and conviction records as per applicable laws. For locations like Los Angeles County, refer to local disclosures on the career site. Seniority level
Director Employment type
Full-time Job function
Health Care Provider Industries Pharmaceutical Manufacturing
#J-18808-Ljbffr
Join to apply for the
Clinical Development Lead, Rheumatology
role at
Bristol Myers Squibb Working with Us Challenging. Meaningful. Life-changing. Those words describe more than a typical job at Bristol Myers Squibb. You will be part of a global environment where important work happens every day, across departments, from optimizing processes to breakthroughs in cell therapy, transforming patients lives and career paths. Bristol Myers Squibb values balance and flexibility, offering competitive benefits and programs to support employees in work and personal goals. Read more: careers.bms.com/working-with-us. Position Summary / Objective
The Clinical Development Lead sits within Clinical Development, a global organization dedicated to the effective design and execution of drug development. The team drives clinical development strategy, design, execution, and interpretation of clinical trials. Responsibilities
Serve as the clinical point of accountability for the Development Team and the overall clinical development plan for asset(s) in one or more indication(s)/tumor type(s). Ensure studies are aligned with target label indications and designed to meet regulatory, quality, medical, and access goals. Act as a matrix leader to lead, develop, motivate and achieve results through teams, and serve as direct manager to Clinical Trial Physicians (CTPs). Accountable for the clinical contribution to the development of each indication strategy, including registrational and non-registrational studies, with support from CTPs and Clinical Scientists. 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. Partner with Clinical Scientist for design, execution, and analyses of each study; proactively collaborate with CTPs and CSs. Accountable for clinical content for CSRs, regulatory reports, briefing books and submission documents; champion a quality-focused mindset and ensure adherence to GCP and compliance obligations. Represent Clinical Development in internal and external forums as the consulted authority for the disease area; partner with Worldwide Patient Safety physicians on safety data reviews. Serve as (co-)leader of the cross-functional Clinical Development Team; provide clinical leadership and disease area expertise into integrated strategies; partner with KOLs in specific indications. Serve as Primary Clinical Representative in Regulatory interactions; evaluate strategic options against the Target Product Profile (TPP). Collaborate with Global Development Operations/Global Compliance to develop asset-level risk management plans, resolve issues with Quality/CS, and escalate to DT as needed. Set executional priorities; partner with CTP and CS to support delivery of studies; accountable for top line data with support of CTP, CS, and Statisticians.
Qualifications
MD preferably with appropriate sub-specialty training; PhD, Pharm D or other health-related field with deep understanding of the clinical principles in the area, or equivalent therapy area knowledge. At least 9 years of relevant experience.
Experience & Competencies
Leadership in the design and execution of multiple clinical trials; ability to synthesize data to formulate clinical strategy and ensure a viable registrational strategy. Experience in personnel needs assessment, hiring strategy, and leading hiring efforts; ability to partner for enterprise-level asset/indication strategy across early, late, and post-marketing development. Proven leadership as Clinical Trial Physician, Clinical Scientist, or equivalent with a track record of people management. Ability to lead a group of CTPs to ensure scientific and technical excellence of development programs and deliverables. Strong skills in clinical development strategy, regulatory submission components, external relationship building with key opinion leaders and collaborators outside of BMS. Ability to collaborate with Early Development teams to ensure seamless transition into late-stage development.
Travel
Domestic and International travel may be required. Compensation & Benefits
The starting compensation for this job is a range from $313,200-379,500 plus incentive cash and stock opportunities (based on eligibility). Final compensation is determined based on demonstrated experience. Benefits vary by location and role. For more on benefits, visit the career site. Legal & Workplace Information
BMS is committed to equal employment opportunity and providing accommodations in recruitment. If you require reasonable accommodations, contact adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility for the EEO statement. Covid-19 vaccination is encouraged for employee well-being. BMS may consider applicants with arrest and conviction records as per applicable laws. For locations like Los Angeles County, refer to local disclosures on the career site. Seniority level
Director Employment type
Full-time Job function
Health Care Provider Industries Pharmaceutical Manufacturing
#J-18808-Ljbffr