Senior Director, Development Business Operations
The Senior Director, Development Business Operations is a leadership position within the Global Blood Therapeutics' Development team, reporting into the VP, Development Operations. This role will influence the strategy and execution of GBT's clinical programs and the supporting business processes. This position is responsible for the strategic oversight of three Development Operations functions, namely Business Operations & Analytics, Operational Excellence and Clinical Outsourcing. Responsibilities of this group includes but is not limited to vendor management processes and sourcing strategy, budget and resourcing planning, data and analytics, business processes and systems (e.g. TMF, CTMS, EDC, etc.), and GXP compliance and risk management. Essential Duties and
Responsibilities:
Sets vision and multi-year strategies for the Development Operations organization in support of Development business objectives Sets and manages functional resourcing strategy and planning for Development Operations Sponsors and/or leads cross-functional teams within Development and/or GBT Champions innovation and new ideas with senior management and outside partners Leverages team(s) to navigate complex, multidimensional problems and develop innovative solutions Models optimal data driven/risk based decision-making processes and influences and delegates decision-making at appropriate levels of the organization Oversight of process maturity, including assessment and continual process improvement activities in collaboration with Development and relevant GBT functions Oversight for development and documentation of business processes and associated technology solutions to optimize business performance Oversight for GXP compliance and risk management process development and performance monitoring Oversight for sourcing and vendor management strategy and vendor lifecycle processes Oversight for data and analytics strategy and advancing analytics maturity in partnership with Development and information technology functions Successful management of current group as well as recruitment future team members (FTEs and consultants/contractors)
Qualifications:
12
years of relevant experience and has earned a BS or equivalent degree; MS, MBA or equivalent may be desirable 5
years of experience managing people in leadership positions Visionary and passionate about implementing innovation Demonstrated ability to assess current and future business needs and develop implementation strategies to support business objectives Demonstrated leadership ability and evidence of coaching, mentoring and career development of direct reports and colleagues Depth of experience in common Development systems and analytics tools and their business application Strong interpersonal and communication skills and evidence of effective cross-departmental collaboration at all levels of the organization Self-directed, proactive, and ability to thrive in a fast-paced, entrepreneurial, dynamic environment with high performing colleagues Demonstrated broad organizational expertise to manage a diverse group of functional activities Proficiency in clinical research regulations and guidance, including FDA CFR and ICH GCP and experience supporting internal and external inspection activities Knowledge and experience with managing complex clinical development situations Familiarity with common Clinical Development metrics, industry-standard performance levels and the implementation of continuous process improvement methodologies (such as Six Sigma, Lean/Kaizen, Agile, Quality Function Deployment, etc.) Experience in the vendor management lifecycle, including vendor audit processes, vendor oversight and performance monitoring. Understands and appreciates the value of long-term relationships with external parties. Fit with GBT culture:
Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE:
This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position may require you to work onsite or interact in person with customers of the Company and/or work onsite from time to time at the Company's facilities. The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely-held religious belief, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully-vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.
Salary Range:
$250K -- $500K+
Minimum Qualification
Sales Management & Operations, Business DevelopmentEstimated Salary: $20 to $28 per hour based on qualifications.
Responsibilities:
Sets vision and multi-year strategies for the Development Operations organization in support of Development business objectives Sets and manages functional resourcing strategy and planning for Development Operations Sponsors and/or leads cross-functional teams within Development and/or GBT Champions innovation and new ideas with senior management and outside partners Leverages team(s) to navigate complex, multidimensional problems and develop innovative solutions Models optimal data driven/risk based decision-making processes and influences and delegates decision-making at appropriate levels of the organization Oversight of process maturity, including assessment and continual process improvement activities in collaboration with Development and relevant GBT functions Oversight for development and documentation of business processes and associated technology solutions to optimize business performance Oversight for GXP compliance and risk management process development and performance monitoring Oversight for sourcing and vendor management strategy and vendor lifecycle processes Oversight for data and analytics strategy and advancing analytics maturity in partnership with Development and information technology functions Successful management of current group as well as recruitment future team members (FTEs and consultants/contractors)
Qualifications:
12
years of relevant experience and has earned a BS or equivalent degree; MS, MBA or equivalent may be desirable 5
years of experience managing people in leadership positions Visionary and passionate about implementing innovation Demonstrated ability to assess current and future business needs and develop implementation strategies to support business objectives Demonstrated leadership ability and evidence of coaching, mentoring and career development of direct reports and colleagues Depth of experience in common Development systems and analytics tools and their business application Strong interpersonal and communication skills and evidence of effective cross-departmental collaboration at all levels of the organization Self-directed, proactive, and ability to thrive in a fast-paced, entrepreneurial, dynamic environment with high performing colleagues Demonstrated broad organizational expertise to manage a diverse group of functional activities Proficiency in clinical research regulations and guidance, including FDA CFR and ICH GCP and experience supporting internal and external inspection activities Knowledge and experience with managing complex clinical development situations Familiarity with common Clinical Development metrics, industry-standard performance levels and the implementation of continuous process improvement methodologies (such as Six Sigma, Lean/Kaizen, Agile, Quality Function Deployment, etc.) Experience in the vendor management lifecycle, including vendor audit processes, vendor oversight and performance monitoring. Understands and appreciates the value of long-term relationships with external parties. Fit with GBT culture:
Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE:
This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position may require you to work onsite or interact in person with customers of the Company and/or work onsite from time to time at the Company's facilities. The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely-held religious belief, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully-vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.
Salary Range:
$250K -- $500K+
Minimum Qualification
Sales Management & Operations, Business DevelopmentEstimated Salary: $20 to $28 per hour based on qualifications.
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