Freeline Therapeutics
Senior Clinical Project Manager
Freeline Therapeutics, Boston, Massachusetts, us, 02298
Why Spur?
Gene therapy is at an inflection point. Amidst the noise of countless emerging modalities, we've been hard at work refining our science and advancing our programs with quiet determination and a bold ambition to unlock the true potential of gene therapy to change the trajectory of more patients' lives. Come join Spur's dedicated team of scientists, physicians and other professionals who are singularly focused on using cutting-edge science and technology to transform the treatment of serious and debilitating chronic diseases.
What We Are Trying to Accomplish
We are a clinical-stage biotech company developing transformative adeno-associated virus (AAV) vector-mediated gene therapies. Founded in 2015, Spur is focused on developing innovative, one-time treatments that set new standards of care. Our integrated gene therapy platform includes in-house capabilities in research, protein engineering and clinical development, and we optimize every component of our product candidates to develop first- and best-in-class gene therapies. We are currently advancing a highly differentiated gene therapy candidate in a Phase 1/2 clinical trial in people with Gaucher disease. We are working on additional programs in research, with a focus on CNS and cardiovascular diseases, to reach even more patients with our potentially life-changing treatments. Spur is global, with research facilities and offices in Stevenage, UK, and offices in Boston and New York.
How We Will Do It
We are relentless in our pursuit of transformative medicines for patients. We take innovation seriously and know we need to be bold both in our science and in every aspect of our work. We also know we can only achieve these things together, so we act as one Spur and expect that of each colleague in the company. We always do the right thing – the trust of patients and their caregivers is critical to our success. If you have an entrepreneurial mindset, are willing to work hard to transform the lives of patients, and share our values, then Spur could be the place for you.
Role Purpose
This is a hybrid position, located in Boston, MA.
Responsibilities
Study Leadership & Management
Lead the planning and execution of clinical program(s) from Phase I to IV in adherence to Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations, EU Directives & Guidance, International Conference on Harmonisation (ICH) guidelines and any other applicable guidelines (e.g. regional or country requirements).
Proven leader in clinical program management.
Lead team to ensure major study milestones and associated budget align with the overall development plan agreed by the Project Team.
Oversee site selection and site qualification discussions with Project Team and CRO.
Provide input and review for the protocol and amendments ensuring design of efficient clinical trial protocols, tools, and procedures for data collection and processing, as well as the collection of information that is essential to decision making.
Review and provide input on ICF, Investigator Brochure, DSUR, and Clinical Study Report.
Lead study team meetings.
Prepare the Trial Oversight Plan (and other study plans as required) and ensure adherence.
Ensure maintenance of the Trial Master File and lead periodic reviews to ensure inspection readiness.
Proactive sharing of lessons learned across programs.
Travel to national and international sites as required for sponsor-led audits, investigator meetings and relevant conferences.
CRO, Vendors, and Quality Oversight
Experience with the RFP process and appropriate selection of the CRO and all vendors in alignment with Freeline SOPs.
Validate the study plans provided by the CRO and ensure CRO complete periodic reviews/updates of plans through the lifecycle of the study.
Proven abilities with proactive, solutions-oriented management of CRO performance to ensure adherence to scope of work within timelines and budget at overall study level.
Track major study milestones and monitor overall operational and key performance metrics through the life of the study.
Proactive management of issues and risk along with suggested mitigations and contingencies.
Review and agree budget at study planning and monitor the overall agreed budget against study progress.
Management of out of scopes with CRO and ensure these are appropriate and incorporated into contract modifications in a timely manner.
Oversee the CRO performance to ensure compliance with agreed scope of work, SOPs, applicable regulations and Freeline's quality standards.
Escalate and provide insight into CRO performance trends within a clinical study or across several studies and provide suggested solutions.
Serve as CRO primary contact for protocol clarifications, issue escalations, and protocol-specific logistical issues.
Quality
Contributes towards development and implementation of process to ensure clinical studies are managed within a robust regulatory and operational framework.
Collaborates with other key functions to maintain audit and inspection readiness.
Experience qualifying and managing vendor selection is completed in alignment with the Quality Management System and standards.
Ensure quality control is applied to ensure that all data is reliable and processed correctly in accordance with quality agreements.
Qualifications & Experience Required
Degree in a relevant life sciences or related discipline or background as Registered Nurse.
7+ years' experience within the pharmaceutical industry in clinical operations, including project management experience, ideally at global level.
Demonstrated leadership capabilities and ability to lead and motivate high functioning teams and adaptable to varied goals or directives.
Excellent judgement and reasoning skills to define problems, collect and analyse, establish facts and recommend a course of action.
Excellent problem-solving and decision-making skills with the ability to balance autonomy with collaboration in decision making.
Strong experience of vendor management and oversight of clinical studies and study teams across all phases of development.
Familiarity with a broad spectrum of clinical operations concepts, practices, and procedures with an understanding of the process and regulations that apply to clinical investigations including knowledge of EMA/FDA regulatory requirements and ICH GCP guidelines.
Highly organised and able to plan, prioritise and manage time efficiently.
Strong oral and written communication skills.
Collaborative working style with ability to partner and communicate across the organisation.
Self-motivated and able to work independently.
Able to effectively prioritise activity to fit with company priorities.
Strong project financial acumen.
Strong scientific, operational and regulatory expertise. Demonstrates knowledge of design and operational management of clinical studies globally, including regulatory requirements, CRO capabilities and compliance practices.
Ability to communicate effectively, including with therapy area experts and patient advocacy groups.
#J-18808-Ljbffr
Gene therapy is at an inflection point. Amidst the noise of countless emerging modalities, we've been hard at work refining our science and advancing our programs with quiet determination and a bold ambition to unlock the true potential of gene therapy to change the trajectory of more patients' lives. Come join Spur's dedicated team of scientists, physicians and other professionals who are singularly focused on using cutting-edge science and technology to transform the treatment of serious and debilitating chronic diseases.
What We Are Trying to Accomplish
We are a clinical-stage biotech company developing transformative adeno-associated virus (AAV) vector-mediated gene therapies. Founded in 2015, Spur is focused on developing innovative, one-time treatments that set new standards of care. Our integrated gene therapy platform includes in-house capabilities in research, protein engineering and clinical development, and we optimize every component of our product candidates to develop first- and best-in-class gene therapies. We are currently advancing a highly differentiated gene therapy candidate in a Phase 1/2 clinical trial in people with Gaucher disease. We are working on additional programs in research, with a focus on CNS and cardiovascular diseases, to reach even more patients with our potentially life-changing treatments. Spur is global, with research facilities and offices in Stevenage, UK, and offices in Boston and New York.
How We Will Do It
We are relentless in our pursuit of transformative medicines for patients. We take innovation seriously and know we need to be bold both in our science and in every aspect of our work. We also know we can only achieve these things together, so we act as one Spur and expect that of each colleague in the company. We always do the right thing – the trust of patients and their caregivers is critical to our success. If you have an entrepreneurial mindset, are willing to work hard to transform the lives of patients, and share our values, then Spur could be the place for you.
Role Purpose
This is a hybrid position, located in Boston, MA.
Responsibilities
Study Leadership & Management
Lead the planning and execution of clinical program(s) from Phase I to IV in adherence to Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations, EU Directives & Guidance, International Conference on Harmonisation (ICH) guidelines and any other applicable guidelines (e.g. regional or country requirements).
Proven leader in clinical program management.
Lead team to ensure major study milestones and associated budget align with the overall development plan agreed by the Project Team.
Oversee site selection and site qualification discussions with Project Team and CRO.
Provide input and review for the protocol and amendments ensuring design of efficient clinical trial protocols, tools, and procedures for data collection and processing, as well as the collection of information that is essential to decision making.
Review and provide input on ICF, Investigator Brochure, DSUR, and Clinical Study Report.
Lead study team meetings.
Prepare the Trial Oversight Plan (and other study plans as required) and ensure adherence.
Ensure maintenance of the Trial Master File and lead periodic reviews to ensure inspection readiness.
Proactive sharing of lessons learned across programs.
Travel to national and international sites as required for sponsor-led audits, investigator meetings and relevant conferences.
CRO, Vendors, and Quality Oversight
Experience with the RFP process and appropriate selection of the CRO and all vendors in alignment with Freeline SOPs.
Validate the study plans provided by the CRO and ensure CRO complete periodic reviews/updates of plans through the lifecycle of the study.
Proven abilities with proactive, solutions-oriented management of CRO performance to ensure adherence to scope of work within timelines and budget at overall study level.
Track major study milestones and monitor overall operational and key performance metrics through the life of the study.
Proactive management of issues and risk along with suggested mitigations and contingencies.
Review and agree budget at study planning and monitor the overall agreed budget against study progress.
Management of out of scopes with CRO and ensure these are appropriate and incorporated into contract modifications in a timely manner.
Oversee the CRO performance to ensure compliance with agreed scope of work, SOPs, applicable regulations and Freeline's quality standards.
Escalate and provide insight into CRO performance trends within a clinical study or across several studies and provide suggested solutions.
Serve as CRO primary contact for protocol clarifications, issue escalations, and protocol-specific logistical issues.
Quality
Contributes towards development and implementation of process to ensure clinical studies are managed within a robust regulatory and operational framework.
Collaborates with other key functions to maintain audit and inspection readiness.
Experience qualifying and managing vendor selection is completed in alignment with the Quality Management System and standards.
Ensure quality control is applied to ensure that all data is reliable and processed correctly in accordance with quality agreements.
Qualifications & Experience Required
Degree in a relevant life sciences or related discipline or background as Registered Nurse.
7+ years' experience within the pharmaceutical industry in clinical operations, including project management experience, ideally at global level.
Demonstrated leadership capabilities and ability to lead and motivate high functioning teams and adaptable to varied goals or directives.
Excellent judgement and reasoning skills to define problems, collect and analyse, establish facts and recommend a course of action.
Excellent problem-solving and decision-making skills with the ability to balance autonomy with collaboration in decision making.
Strong experience of vendor management and oversight of clinical studies and study teams across all phases of development.
Familiarity with a broad spectrum of clinical operations concepts, practices, and procedures with an understanding of the process and regulations that apply to clinical investigations including knowledge of EMA/FDA regulatory requirements and ICH GCP guidelines.
Highly organised and able to plan, prioritise and manage time efficiently.
Strong oral and written communication skills.
Collaborative working style with ability to partner and communicate across the organisation.
Self-motivated and able to work independently.
Able to effectively prioritise activity to fit with company priorities.
Strong project financial acumen.
Strong scientific, operational and regulatory expertise. Demonstrates knowledge of design and operational management of clinical studies globally, including regulatory requirements, CRO capabilities and compliance practices.
Ability to communicate effectively, including with therapy area experts and patient advocacy groups.
#J-18808-Ljbffr