Clinical Development Program Lead, Hematology

Clinical Development Program Lead, Hematology

BMS - Bristol-Myers Squibb

Boudry, Switzerland

Position Description:

The Clinical Development Program Leader (CDPL), Hematology sits within Clinical Development, 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.

Position Summary / Objective:

• The Clinical Development Program Leader will set the clinical development strategy for assets or indications
• The Clinical Development Program Leader will directly supervise the work of Clinical Development Leads who will in turn supervise individual Clinical Trial Physicians unless otherwise indicated
• This role will include above disease / indication strategy work (i.e. supervising Broad Clinical Development teams across several Development teams, as well as Disease / Indication Strategy teams etc.)
• The role will be foundational in working with teams in R & ED and GDD to support GT4/5 and POC transitions, providing insights into biology, translational elements as well as overall benefit risk assessments
• The role will supervise the development of differentiated and strategic Clinical Development Programs for transition assets and support a broad program of work from phase I expansion through to registrational execution
• The role includes support of across portfolio activities in line with Clinical Excellence, including e.g. Protocol Review Committee, support of Business Development activities and Quality and Compliance leadership
• The role will report directly to the Head of Clinical Development and will deputize as required, and will be a core member of the Therapeutic Area clinical development leadership team

Position Responsibilities:

Strategy and Execution

• Create and communicate a vision for designing, conducting and executing innovative clinical development plans
• This leader will supervise the development, monitoring, analysis and interpretation of clinical trials and will supervise and have accountability for the clinical components of regulatory filings
• Will contribute to overall strategy for specific disease / indications while ensuring a franchise overall portfolio view
• Provide strategic insights into the clinical development plans
• Lead search and evaluation activities on business development due diligence efforts, and advice to our strategic transactions group
• Key Member of Therapeutic Area Clinical Development Leadership Team and chairing forum as required
• Will build a franchise reputation that attracts innovators to bring their ideas to BMS

Drug Development Experience

• Will create a Clinical Development strategy to develop programs beyond commercialization and launch and into lifecycle management

Leadership and Matrix Management

• Lead and develop a group of Clinical Development professionals (both direct and indirect) whose therapeutic area focus is in a specific disease area / indication and will ensure scientific and technical excellence of clinical development programs and deliverables
• This individual will recruit, develop and retain strong talent
• Mentoring of talent/staff
• Will establish an effective and ethical culture that encourages teamwork, peer review, promotes cooperation and provides a supportive culture
• Will be responsible for developing a culture that values diversity of thought, supports coaching, fosters accountability and integrity, and supports process excellence and continuous improvement
• Will be responsible for oversight of team budget and headcount

Stakeholder Engagement and Communication

• Will work closely with colleagues in BMS Research, Development, Regulatory, Medical, Commercial and other key functional areas on a global basis; additionally should have an external focus and build relationships with thought leaders, physicians, and patient advocacy groups outside of BMS. Be recognized internally and externally as an expert in the field
• Partner and interact with colleagues from Research and Early Development who design and implement first in human through proof of concept trials and will assure a seamless transition into late stage development (Phase II-III trials.)

Governance Participation and Signature Authority

• Governance participation ad hoc as designated
• Signature Authority for:
  • CSRs
  • Health Authority Briefings
  • DMC Charters
  • Unblinding Requests
  • Health Authority Documents for Filings
  • And other clinical accountable documents delegated as needed

Degree Requirements

• MD (PhD or other high level degree optional)

Experience Requirements:

• The ideal candidate will be a clinical development leader; with greater than 12 years of extensive clinical trial, drug development, and regulatory experience, in addition to a strong scientific background
• Management experience required since this individual will manage a potentially large group of professionals including MDs or PhDs or PharmDs with clinical research experience.
• The successful candidate will understand early-stage drug development, extensive experience designing and conducting Phase I, II and Phase III clinical trials, and should have demonstrable success filing regulatory dossiers and prosecuting them through approval
• Global experiences is a plus since this position has responsibility for strategy and clinical research in oncology in multiple geographies
• Experience interacting with business development and licensing, particularly helping to evaluate the technical and franchise aspects for potential in-licensing opportunities that shape the oncology clinical development strategy

Key Competency Requirements

• Proven track record in managing complex clinical programs leading to regulatory submissions
• Deep understanding of biology, targets and translational science
• Extensive experience of work with health authorities at all levels
• Proven differentiated ability to support and manage across the totality of the spectrum including development of registrational and non-registrational trials
• Proven ability to execute the BMS R&D People Strategy, and lead and develop a matrix team
• The candidate also must be a highly effective leader capable of working with Commercial, Medical, and all research functions of the company from Research through Regulatory
• The candidate must be comfortable with cross-functional drug and product development teams and managing in a matrix environment
• In addition, the candidate must be skilled at interacting externally, and at speaking engagements
• Must be skilled at attracting, developing, and retaining skilled professionals

Travel Required

• Domestic and International travel may be required.

Apply Now

More Job Searches

Switzerland      Clinical Research      On-site      Pre-clinical Research and Development      BMS - Bristol-Myers Squibb