Senior Manager, Clinical Outsourcing at Global Blood Therapeutics in South San Francisco, CA
Position
Summary:
The Senior Manager, Clinical Outsourcing is a full-time position within GBT's Clinical Development team, reporting to the Director, Clinical Outsourcing. The Senior Manager is accountable for the delivery of clinical outsourcing strategy and execution; specifically, vendor selection, financial due diligence and vendor relationship management in support of the Development organization. This includes being a collaborative and effective business partner in a high growth, dynamic organization. This position will be a self-motivated individual who can drive initiatives to conclusion, solve problems and be deadline oriented. Essential Duties and
Responsibilities:
Sourcing and Vendor:
Lead the identification and selection of clinical vendors, with a focus in supporting the Development organization Manage the documents needed to affect the selection of the optimal external service provider (ESP) Negotiate contract business terms, scopes of work, pricing and payment schedules. Ensure agreements are commercial advantageous to GBT while minimizing risk through close collaboration with functional partners such as legal, finance, and clinical Assist clinical teams in defining and reviewing vendor change orders/amendments Collaborate with Legal and Finance to lead the resolution of contractual and budgetary issues Manage traffic of contractual documents to ensure timely and compliant execution Participate in and help manage vendor governance and relationship management efforts Help ensure Vendors/Partners are delivering in line with expectations and contracts Budgetary:
Assist in budget development and maintenance for the Development organization Work closely with Clinical Operations and Finance regarding the monthly accrual process intended to provide timely and accurate clinical cost accruals Miscellaneous:
Assist in the identification and quantification of financial/operational risks and opportunities to the business Contribute to continued process improvement efforts, including but not limited to department processes to ensure adherence to GBT's standards, and all applicable regulations and guidelines Secure all necessary approvals to ensure compliance to SOX and company procedures Help establish and report KPIs and metrics to measure departmental process and vendor performance Adhere to GBT's Working Practices, Standard Operating Procedures (SOPs) and ensure compliance to SOX and company policies Drive ad-hoc business projects as necessary
Qualifications:
Bachelor's degree (preferred) or equivalent experience. 6-9 years of experience in clinical outsourcing, or related discipline, within the drug development industry Knowledgeable about drug development and the conduct of clinical trials Ability to work effectively in a team environment, but also able to think independently and lead initiatives Excellent organizational skills and attention to detail Applies strong analytical and business communication skills Ability to efficiently perform multiple tasks and manage changing priorities 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 requires you to work onsite 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:
$80K -- $100K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Summary:
The Senior Manager, Clinical Outsourcing is a full-time position within GBT's Clinical Development team, reporting to the Director, Clinical Outsourcing. The Senior Manager is accountable for the delivery of clinical outsourcing strategy and execution; specifically, vendor selection, financial due diligence and vendor relationship management in support of the Development organization. This includes being a collaborative and effective business partner in a high growth, dynamic organization. This position will be a self-motivated individual who can drive initiatives to conclusion, solve problems and be deadline oriented. Essential Duties and
Responsibilities:
Sourcing and Vendor:
Lead the identification and selection of clinical vendors, with a focus in supporting the Development organization Manage the documents needed to affect the selection of the optimal external service provider (ESP) Negotiate contract business terms, scopes of work, pricing and payment schedules. Ensure agreements are commercial advantageous to GBT while minimizing risk through close collaboration with functional partners such as legal, finance, and clinical Assist clinical teams in defining and reviewing vendor change orders/amendments Collaborate with Legal and Finance to lead the resolution of contractual and budgetary issues Manage traffic of contractual documents to ensure timely and compliant execution Participate in and help manage vendor governance and relationship management efforts Help ensure Vendors/Partners are delivering in line with expectations and contracts Budgetary:
Assist in budget development and maintenance for the Development organization Work closely with Clinical Operations and Finance regarding the monthly accrual process intended to provide timely and accurate clinical cost accruals Miscellaneous:
Assist in the identification and quantification of financial/operational risks and opportunities to the business Contribute to continued process improvement efforts, including but not limited to department processes to ensure adherence to GBT's standards, and all applicable regulations and guidelines Secure all necessary approvals to ensure compliance to SOX and company procedures Help establish and report KPIs and metrics to measure departmental process and vendor performance Adhere to GBT's Working Practices, Standard Operating Procedures (SOPs) and ensure compliance to SOX and company policies Drive ad-hoc business projects as necessary
Qualifications:
Bachelor's degree (preferred) or equivalent experience. 6-9 years of experience in clinical outsourcing, or related discipline, within the drug development industry Knowledgeable about drug development and the conduct of clinical trials Ability to work effectively in a team environment, but also able to think independently and lead initiatives Excellent organizational skills and attention to detail Applies strong analytical and business communication skills Ability to efficiently perform multiple tasks and manage changing priorities 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 requires you to work onsite 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:
$80K -- $100K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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