Sr. Clinical Trial Leader, US Medical Affairs at Roche in South San Francisco, CA
Purpose:
The Sr. Clinical Trial Leader (CTL) will lead one or more cross-functional Study Management Teams (SMTs) and/or Study Review Teams (SRTs), provide strategic planning and organization to ensure successful study completion, and ensure the development and maintenance of productive relationships with our customers. The Sr. CTL will maintain full accountability of the USMA portion of a study and ensure the timely and efficient delivery of the clinical study including the operational aspects through all stages (startup, conduct and close-down) in accordance with the medical plan with appropriate quality standards including the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Good Clinical Practice (GCP) standards, Genentech/Roche Standard Operating Procedures (SOPs), local operating guidelines and local regulatory requirements. Note:
All Genentech/Roche employees are expected to effectively contribute to cross-functional collaboration, coordination and comply with all laws, regulations, policies and procedures that govern our business. Role Responsibilities/Accountabilities:
In this position, you will be primarily accountable for consistently and effectively:
Provide direction and leadership to one or more SMTs to ensure delivery of all cross functional activities to meet study plans outlined in medical plans. Primary SMT contact for internal stakeholders, and responsible for driving and making clear study-level decisions in the SMT environment. Contribute clinical operations expertise into medical plans and study design, timelines and budget. Chair SMT meetings and other meetings involving external partners/stakeholders (investigator, vendor(s) as appropriate), and compliantly develop and cultivate productive relationships. Build and maintain effective high performing SMTs by ensuring clarity of roles, responsibilities, accountabilities, and deliverables for members. Ensure SMT receives applicable training; including therapeutic area training, protocol training, etc. at study kick-off. Represent the SMT at various cross-functional teams (e.g. medical team, filing team as required), and may serve as an ad-hoc member. Provide Contract Research Organization (CRO) and other vendor(s) direction and oversight, and ensure that they deliver against contracted scope of work. Finalize study budget and ensure it is in alignment with project and study-level assumptions based upon high level estimate from Clinical Program Leader (CPL). Accountable for accuracy of forecasting and ensuring adjustments are made as necessary (via CPL consult). Ensure all relevant functional groups provide input to develop and finalize core study documents including protocol, informed consent forms (ICFs), electronic case report forms (eCRFs) and various operations documents. Ensure clinical data is reviewed in accordance with the study data plans. Oversee the safety reporting activities and ensure reporting timelines are met. Manage overall risk and quality of the study; contribute to study management and clinical operations excellence by identifying opportunities, mitigating risks and supporting continuous improvement. Identify and contribute to areas of best practices and process improvements. Provide study specific mentoring to CTLs and Clinical Trial Associates (CTAs) as appropriate and partner with Clinical Operations Leaders (COLs) to contribute to CTL and CTA development needs. In this position, you will also be responsible as an Operations representative to:
Serve as a member of one or more cross-functional SMTs and SRTs as applicable through all study stages (start-up, conduct, close-out) as outlined in the medical plan. Liaise with SMT members, solicit feedback, provide operational input, and help develop and finalize critical clinical trial documents such as country and site level budget templates, electronic data capture (EDC), interactive voice/web response system (IxRS), central/specialty lab, electrocardiogram (ECG), imaging, patient reported outcomes (PRO) specifications, drug supply and biomarker/sample management plans, trial master file (TMF), clinical study report (CSR). Responsible for leading the identification and selection of vendors (participate in the request for proposal (RFP) process) in collaboration with the CPL. Ensure appropriate cross-functional input is incorporated into the scope of work. Manage assigned vendor budget(s); communicate variances in actual versus forecasted spend in vendor budgets and present an action plan for resolution to the CPL. Support Clinical Trial Management System (CTMS) and data maintenance, timeline planning tools and other core systems. Actively partner with Data Management and Medical to oversee eCRF completion and data quality issues. Develop/track operational activities such as study budget, timelines, milestones, and critical study activities; identifying issues and proposing potential resolutions. Lead the development of protocol level feasibility and finalize country/site selection with CPL input. Partner with the Site Contracts group on development of site budget template and budget negotiations. Coordinate planning and execution of effective investigator meeting. As appropriate/applicable, drive agenda and content for investigator meetings. Develop and actively manage study patient recruitment strategies. Responsible for assessing feasibility of and driving execution/adherence to protocol and amendments or changes to clinical studies across functions. Utilize outputs from operational analytical tools to enhance and improve study execution. Accountable for drug supply requirements and availability across studies in liaison with the Pharma Technical Drug Supply (PTDS) group. Ensure completion and finalization of any corrective and preventive action plan(s) resulting from site audits and/or inspections. Ensure study adherence to ICH/GCP and SOPs. Other:
o Stay current on relevant therapeutic knowledge and clinical research best practices. Participate in the evaluation of standards across one or more SMT(s)/SRT(s) with the objective of enhancing quality, productivity and efficiency. Provide support, mentoring and study-specific training to other USMA Clinical Operations team members. As appropriate, serve as subject matter expert on task forces, initiatives and various working groups; contributing to USMA and USMA Clinical Operations initiatives. Skills:
Strong leadership and motivational skills developed through leading successful cross-functional matrix study teams through all stages of clinical studies Applies critical thinking and aims to simplify work. Strives for efficiency. Ability to influence, negotiate and manage conflicts. Self-motivated and achievement driven. Proven track record of meeting or exceeding objectives and goals on a consistent basis. Demonstrable abilities to work more independently (with less guidance and supervision) in strategizing, designing and overseeing local clinical study plans and projects. Strong business acumen:
knows the industry, key competitors and other marketplace factors/dynamics. Good project and process management skills:
can prioritize multiple tasks and goals to ensure timely, on-target and within-budget accomplishment of such. Good communication and presentation skills:
communicates in a timely, thorough and concise manner and is comfortable presenting information to others at varying organizational levels. Strong interpersonal and partnering skills:
has proven abilities to work effectively and efficiently in cross-functional, often virtual and matrix teams. Financial acumen:
proven abilities for effective planning, development and oversight of project budgets and other resources Strong customer orientation/focus Good computer skills, including common desktop programs Business travel, by air or car, may be required for internal and external business meetings Background/Experience and Education:
Bachelor's Degree in a medical/science-related discipline Strong knowledge of ICH-GCP and other relevant standards and guidelines Strong knowledge of operational aspects of clinical trial management and the drug development process, including vendor/CRO management Demonstrated experience in at least therapeutic areas relevant to the work of Genentech/Roche o Experienced in managing aspects of one or more global, complex, clinical studies 7
years of proven experience in clinical research and development Participating in or leading a Study Management Team Implementing clinical development/medical plans, risk management plans, and management of complex study budgets and resourcing plans. Coordinating study level activities to deliver data for filing or publication purposes This position is preferably located in South San Francisco, CA, however, we welcome candidates from all US territories as working remotely is a possibility. Relocation benefits are not available for this job posting.
Salary Range:
$150K -- $200K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
The Sr. Clinical Trial Leader (CTL) will lead one or more cross-functional Study Management Teams (SMTs) and/or Study Review Teams (SRTs), provide strategic planning and organization to ensure successful study completion, and ensure the development and maintenance of productive relationships with our customers. The Sr. CTL will maintain full accountability of the USMA portion of a study and ensure the timely and efficient delivery of the clinical study including the operational aspects through all stages (startup, conduct and close-down) in accordance with the medical plan with appropriate quality standards including the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Good Clinical Practice (GCP) standards, Genentech/Roche Standard Operating Procedures (SOPs), local operating guidelines and local regulatory requirements. Note:
All Genentech/Roche employees are expected to effectively contribute to cross-functional collaboration, coordination and comply with all laws, regulations, policies and procedures that govern our business. Role Responsibilities/Accountabilities:
In this position, you will be primarily accountable for consistently and effectively:
Provide direction and leadership to one or more SMTs to ensure delivery of all cross functional activities to meet study plans outlined in medical plans. Primary SMT contact for internal stakeholders, and responsible for driving and making clear study-level decisions in the SMT environment. Contribute clinical operations expertise into medical plans and study design, timelines and budget. Chair SMT meetings and other meetings involving external partners/stakeholders (investigator, vendor(s) as appropriate), and compliantly develop and cultivate productive relationships. Build and maintain effective high performing SMTs by ensuring clarity of roles, responsibilities, accountabilities, and deliverables for members. Ensure SMT receives applicable training; including therapeutic area training, protocol training, etc. at study kick-off. Represent the SMT at various cross-functional teams (e.g. medical team, filing team as required), and may serve as an ad-hoc member. Provide Contract Research Organization (CRO) and other vendor(s) direction and oversight, and ensure that they deliver against contracted scope of work. Finalize study budget and ensure it is in alignment with project and study-level assumptions based upon high level estimate from Clinical Program Leader (CPL). Accountable for accuracy of forecasting and ensuring adjustments are made as necessary (via CPL consult). Ensure all relevant functional groups provide input to develop and finalize core study documents including protocol, informed consent forms (ICFs), electronic case report forms (eCRFs) and various operations documents. Ensure clinical data is reviewed in accordance with the study data plans. Oversee the safety reporting activities and ensure reporting timelines are met. Manage overall risk and quality of the study; contribute to study management and clinical operations excellence by identifying opportunities, mitigating risks and supporting continuous improvement. Identify and contribute to areas of best practices and process improvements. Provide study specific mentoring to CTLs and Clinical Trial Associates (CTAs) as appropriate and partner with Clinical Operations Leaders (COLs) to contribute to CTL and CTA development needs. In this position, you will also be responsible as an Operations representative to:
Serve as a member of one or more cross-functional SMTs and SRTs as applicable through all study stages (start-up, conduct, close-out) as outlined in the medical plan. Liaise with SMT members, solicit feedback, provide operational input, and help develop and finalize critical clinical trial documents such as country and site level budget templates, electronic data capture (EDC), interactive voice/web response system (IxRS), central/specialty lab, electrocardiogram (ECG), imaging, patient reported outcomes (PRO) specifications, drug supply and biomarker/sample management plans, trial master file (TMF), clinical study report (CSR). Responsible for leading the identification and selection of vendors (participate in the request for proposal (RFP) process) in collaboration with the CPL. Ensure appropriate cross-functional input is incorporated into the scope of work. Manage assigned vendor budget(s); communicate variances in actual versus forecasted spend in vendor budgets and present an action plan for resolution to the CPL. Support Clinical Trial Management System (CTMS) and data maintenance, timeline planning tools and other core systems. Actively partner with Data Management and Medical to oversee eCRF completion and data quality issues. Develop/track operational activities such as study budget, timelines, milestones, and critical study activities; identifying issues and proposing potential resolutions. Lead the development of protocol level feasibility and finalize country/site selection with CPL input. Partner with the Site Contracts group on development of site budget template and budget negotiations. Coordinate planning and execution of effective investigator meeting. As appropriate/applicable, drive agenda and content for investigator meetings. Develop and actively manage study patient recruitment strategies. Responsible for assessing feasibility of and driving execution/adherence to protocol and amendments or changes to clinical studies across functions. Utilize outputs from operational analytical tools to enhance and improve study execution. Accountable for drug supply requirements and availability across studies in liaison with the Pharma Technical Drug Supply (PTDS) group. Ensure completion and finalization of any corrective and preventive action plan(s) resulting from site audits and/or inspections. Ensure study adherence to ICH/GCP and SOPs. Other:
o Stay current on relevant therapeutic knowledge and clinical research best practices. Participate in the evaluation of standards across one or more SMT(s)/SRT(s) with the objective of enhancing quality, productivity and efficiency. Provide support, mentoring and study-specific training to other USMA Clinical Operations team members. As appropriate, serve as subject matter expert on task forces, initiatives and various working groups; contributing to USMA and USMA Clinical Operations initiatives. Skills:
Strong leadership and motivational skills developed through leading successful cross-functional matrix study teams through all stages of clinical studies Applies critical thinking and aims to simplify work. Strives for efficiency. Ability to influence, negotiate and manage conflicts. Self-motivated and achievement driven. Proven track record of meeting or exceeding objectives and goals on a consistent basis. Demonstrable abilities to work more independently (with less guidance and supervision) in strategizing, designing and overseeing local clinical study plans and projects. Strong business acumen:
knows the industry, key competitors and other marketplace factors/dynamics. Good project and process management skills:
can prioritize multiple tasks and goals to ensure timely, on-target and within-budget accomplishment of such. Good communication and presentation skills:
communicates in a timely, thorough and concise manner and is comfortable presenting information to others at varying organizational levels. Strong interpersonal and partnering skills:
has proven abilities to work effectively and efficiently in cross-functional, often virtual and matrix teams. Financial acumen:
proven abilities for effective planning, development and oversight of project budgets and other resources Strong customer orientation/focus Good computer skills, including common desktop programs Business travel, by air or car, may be required for internal and external business meetings Background/Experience and Education:
Bachelor's Degree in a medical/science-related discipline Strong knowledge of ICH-GCP and other relevant standards and guidelines Strong knowledge of operational aspects of clinical trial management and the drug development process, including vendor/CRO management Demonstrated experience in at least therapeutic areas relevant to the work of Genentech/Roche o Experienced in managing aspects of one or more global, complex, clinical studies 7
years of proven experience in clinical research and development Participating in or leading a Study Management Team Implementing clinical development/medical plans, risk management plans, and management of complex study budgets and resourcing plans. Coordinating study level activities to deliver data for filing or publication purposes This position is preferably located in South San Francisco, CA, however, we welcome candidates from all US territories as working remotely is a possibility. Relocation benefits are not available for this job posting.
Salary Range:
$150K -- $200K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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