Clinical Success Director Job at Abridge (San Francisco)

Clinical Success Director

As a Clinical Success Director, you will be at the forefront of delivering an ex...

Location

United States , San Francisco

Salary:

162500.00 - 192000.00 USD / Year

Abridge

Expiration Date

Until further notice

Requirements

5+ years of experience as a clinician (MD, DO, PA, NP)
Experience with Epic and a deep understanding of clinical documentation workflows
A passion for solving problems and creating new opportunities for clinicians
Proven track record of leading successful initiatives from conception through launch
Ability to build relationships with different layers of an organization, from front-line staff to executives
Strong understanding of the healthcare industry, specifically clinical workflows and regulatory requirements
Experience working with cross-functional teams in a fast-paced, startup environment

Job Responsibility

Provide clinician enablement by delivering education and training to new users, building collateral and strategies to support clinician adoption, and managing relationships with external clinical champions and advisors
Surface product feedback through expert advice on existing clinical documentation strategies and work with product teams to define a clear clinical product roadmap
Provide product strategy recommendations by aggregating user feedback and developing artifacts that articulate how product enhancements may expand the reach of our product(s) and improve clinician user experiences
Develop, monitor, and track end-user utilization and clinical success metrics to help communicate long-term impact and value
Evangelize product capabilities and direction to prospective customers by creating sales collateral, conducting product demos, and more

What we offer

Generous Time Off: 14 paid holidays, flexible PTO for salaried employees, and accrued time off for hourly employees
Comprehensive Health Plans: Medical, Dental, and Vision coverage for all full-time employees and their families
Generous HSA Contribution: If you choose a High Deductible Health Plan, Abridge makes monthly contributions to your HSA
Paid Parental Leave: Generous paid parental leave for all full-time employees
Family Forming Benefits: Resources and financial support to help you build your family
401(k) Matching: Contribution matching to help invest in your future
Personal Device Allowance: Tax free funds for personal device usage
Pre-tax Benefits: Access to Flexible Spending Accounts (FSA) and Commuter Benefits
Lifestyle Wallet: Monthly contributions for fitness, professional development, coworking, and more
Mental Health Support: Dedicated access to therapy and coaching to help you reach your goals

Fulltime

Clinical Success Director

As a Clinical Success Director, you will be at the forefront of delivering an ex...

Location

United States , Chicago or Pittsburgh

Salary:

146250.00 - 172800.00 USD / Year

Abridge

Expiration Date

Until further notice

Requirements

5+ years of experience as a clinician (MD, DO, PA, NP)
Experience with Epic and a deep understanding of clinical documentation workflows
A passion for solving problems and creating new opportunities for clinicians
Proven track record of leading successful initiatives from conception through launch
Ability to build relationships with different layers of an organization, from front-line staff to executives
Strong understanding of the healthcare industry, specifically clinical workflows and regulatory requirements
Experience working with cross-functional teams in a fast-paced, startup environment

Job Responsibility

Provide clinician enablement by delivering education and training to new users, building collateral and strategies to support clinician adoption, and managing relationships with external clinical champions and advisors
Surface product feedback through expert advice on existing clinical documentation strategies and work with product teams to define a clear clinical product roadmap
Provide product strategy recommendations by aggregating user feedback and developing artifacts that articulate how product enhancements may expand the reach of our product(s) and improve clinician user experiences
Develop, monitor, and track end-user utilization and clinical success metrics to help communicate long-term impact and value
Evangelize product capabilities and direction to prospective customers by creating sales collateral, conducting product demos, and more

What we offer

Generous Time Off: 14 paid holidays, flexible PTO for salaried employees, and accrued time off for hourly employees
Comprehensive Health Plans: Medical, Dental, and Vision coverage for all full-time employees and their families
Generous HSA Contribution: If you choose a High Deductible Health Plan, Abridge makes monthly contributions to your HSA
Paid Parental Leave: Generous paid parental leave for all full-time employees
Family Forming Benefits: Resources and financial support to help you build your family
401(k) Matching: Contribution matching to help invest in your future
Personal Device Allowance: Tax free funds for personal device usage
Pre-tax Benefits: Access to Flexible Spending Accounts (FSA) and Commuter Benefits
Lifestyle Wallet: Monthly contributions for fitness, professional development, coworking, and more
Mental Health Support: Dedicated access to therapy and coaching to help you reach your goals

Fulltime

Clinical Success Director

As a Clinical Success Director, you will be at the forefront of delivering an ex...

Location

United States , New York City

Salary:

162500.00 - 192000.00 USD / Year

Abridge

Expiration Date

Until further notice

Requirements

5+ years of experience as a clinician (MD, DO, PA, NP)
Experience with Epic and a deep understanding of clinical documentation workflows
A passion for solving problems and creating new opportunities for clinicians
Proven track record of leading successful initiatives from conception through launch.
Ability to build relationships with different layers of an organization, from front-line staff to executives.
Strong understanding of the healthcare industry, specifically clinical workflows and regulatory requirements
Experience working with cross-functional teams in a fast-paced, startup environment
This role requires up to 20% travel

Job Responsibility

Provide clinician enablement by delivering education and training to new users, building collateral and strategies to support clinician adoption, and managing relationships with external clinical champions and advisors.
Surface product feedback through expert advice on existing clinical documentation strategies and work with product teams to define a clear clinical product roadmap.
Provide product strategy recommendations by aggregating user feedback and developing artifacts that articulate how product enhancements may expand the reach of our product(s) and improve clinician user experiences.
Develop, monitor, and track end-user utilization and clinical success metrics to help communicate long-term impact and value.
Evangelize product capabilities and direction to prospective customers by creating sales collateral, conducting product demos, and more.

What we offer

Generous Time Off: 14 paid holidays, flexible PTO for salaried employees, and accrued time off for hourly employees
Comprehensive Health Plans: Medical, Dental, and Vision coverage for all full-time employees and their families.
Generous HSA Contribution: If you choose a High Deductible Health Plan, Abridge makes monthly contributions to your HSA.
Paid Parental Leave: Generous paid parental leave for all full-time employees.
Family Forming Benefits: Resources and financial support to help you build your family.
401(k) Matching: Contribution matching to help invest in your future.
Personal Device Allowance: Tax free funds for personal device usage.
Pre-tax Benefits: Access to Flexible Spending Accounts (FSA) and Commuter Benefits.
Lifestyle Wallet: Monthly contributions for fitness, professional development, coworking, and more.
Mental Health Support: Dedicated access to therapy and coaching to help you reach your goals.

Fulltime

Clinical Success Director - Nursing

As the Clinical Success Director - Nursing, you will be at the forefront of defi...

Location

United States , San Francisco

Salary:

162500.00 - 192000.00 USD / Year

Abridge

Expiration Date

Until further notice

Requirements

5+ years of experience as an RN, preferably in the inpatient setting
Experience with electronic record systems (Epic is a definite plus)
Passion for deeply understanding nursing workflows and improving inefficiencies
Proven track record of leading successful initiatives from conception through launch
Ability to build relationships with different layers of an organization, from front-line staff to executives
Strong understanding of the healthcare industry, specifically clinical workflows and regulatory requirements
Experience working with cross-functional teams in a fast-paced, startup environment
This role requires 25% travel

Job Responsibility

Evaluate new product offerings and provide subject matter expertise to our product teams
Build and maintain relationships across customers, including onboarding users, listening to customer feedback, optimizing nursing workflows, and identifying opportunities for improved engagement and success
Design and recruit a council of trusted nurse advisors to guide product strategy and roadmap
Develop a use case-specific end-user survey and a set of success metrics to help communicate impact and value
Evangelize product capabilities and direction to prospective customers by creating sales collateral, conducting product demos, training, and more

What we offer

Generous Time Off: 14 paid holidays, flexible PTO for salaried employees, and accrued time off for hourly employees
Comprehensive Health Plans: Medical, Dental, and Vision coverage for all full-time employees and their families
Generous HSA Contribution: If you choose a High Deductible Health Plan, Abridge makes monthly contributions to your HSA
Paid Parental Leave: Generous paid parental leave for all full-time employees
Family Forming Benefits: Resources and financial support to help you build your family
401(k) Matching: Contribution matching to help invest in your future
Personal Device Allowance: Tax free funds for personal device usage
Pre-tax Benefits: Access to Flexible Spending Accounts (FSA) and Commuter Benefits
Lifestyle Wallet: Monthly contributions for fitness, professional development, coworking, and more
Mental Health Support: Dedicated access to therapy and coaching to help you reach your goals

Fulltime

Associate Director / Director, Clinical Quality Assurance

Location

United States , Cambridge

Salary:

185000.00 - 260000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

University degree in a scientific discipline/life sciences OR equivalent experience in biotech/pharmaceutical industry
Experience in a clinical stage biotech company preferred
10+ years of relevant experience in clinical/GCP quality
Outstanding expertise in GCP R3 and solid understanding of PV regulations
Demonstrated ability to successfully partner cross-functionally
Excellent interpersonal effectiveness, including exceptional communication skills
Advanced computer skills, including experience working in Veeva
Consistent excellent judgement and pragmatic, risk-based decision making skills
Direct experience supporting FDA and other global healthy authority (e.g., EMA, MHRA) inspections and related inspection preparation activities

Job Responsibility

Lead development and execution of enterprise-wide GCP inspection readiness strategies and plans
Conduct inspection risk assessments and coordinate mock inspections, readiness reviews, and remediation activities
Support health authority inspections, including document review, response coordination, and follow-up remediation activities
Serve as the Clinical QA Lead for assigned studies and programs
Provide quality review of protocols, informed consent forms, investigator brochures, CSRs, and regulatory submission documents
Develop and execute program/study-level risk-based audit plan, including investigator site, vendor and internal process audits
Provide quality oversight of CRO and key service providers through qualification, ongoing monitoring, and issue escalation
Provide QA oversight of TMF quality and completeness in collaboration with study teams and TMF group
Support TMF migration activities, as required
Lead quality investigations, root cause analysis, and CAPA development

Fulltime

Director, Clinical Affairs

In this role, you will lead the development and execution of clinical strategies...

Location

United States , Skaneateles Falls

Salary:

208000.00 - 286000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

BA/BS in scientific discipline with minimum of 10+ years clinical operations experience (pharmaceutical, biotechnology or medical device industry
medical device preferred)
Expertise in ICH/GCP, ISO 14155, US Federal Food and Drug Administration and European Regulatory Authority requirements, as applicable to a study (or the requirements within countries in which a study is conducted)
Well-established knowledge in overall product development process from Phase 1 through Phase 4 for medical device trials, including software validation as required
Possesses expert knowledge of research objectives, protocol design, and data collection standards
Experience reviewing monitoring reports
High experience/proficiency with clinical operations systems including EDC, CTMS, and eTMF
Able to monitor performance of team in maintaining system updates to allow for senior management reports
Applies current applications/systems to compile information for presentation or distribution
Identifies new uses of current systems or use of new applications to enhance the management capabilities of projects

Job Responsibility

Lead the development and execution of clinical strategies and clinical research programs that enable Baxter’s product innovation and market adoption
Drive clinical planning, study execution, regulatory compliance, and cross‑functional collaboration while overseeing CROs, study sites, budgets, and timelines
Provide leadership to the clinical affairs team, ensuring high‑quality study operations, safety oversight, and successful delivery of clinical evidence supporting Baxter’s global portfolio
Gather business priorities for both pre-market (approval) and post market (evidence) needs for clinical research
Engage collaboratively with Medical Affairs, Marketing, Reimbursement, and R&D resources
Develop strategy and make recommendations for approaches to meet goals for technology feasibility, product validation, claims substantiation or content supporting market adoption
Responsible for the identification and management of necessary resources to successfully initiate and complete clinical trials
Lead Clinical Study Execution team(s) to develop clinical strategies and project plan
Partner with the Medical Monitor, Regulatory Affairs and Commercial to prepare a clinical plan for each project
Facilitate preparation of protocols including study design, case report forms, study procedures

What we offer

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts
Educational assistance programs
Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)

Fulltime

Director, Clinical Affairs

In this role, you will lead the development and execution of clinical strategies...

Location

United States , Skaneateles Falls

Salary:

208000.00 - 286000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

BA/BS in scientific discipline with minimum of 10+ years clinical operations experience (pharmaceutical, biotechnology or medical device industry
medical device preferred)
Expertise in ICH/GCP, ISO 14155, US Federal Food and Drug Administration and European Regulatory Authority requirements, as applicable to a study (or the requirements within countries in which a study is conducted)
Well-established knowledge in overall product development process from Phase 1 through Phase 4 for medical device trials, including software validation as required
Possesses expert knowledge of research objectives, protocol design, and data collection standards
Experience reviewing monitoring reports. High experience/proficiency with clinical operations systems including EDC, CTMS, and eTMF
Able to monitor performance of team in maintaining system updates to allow for senior management reports
Applies current applications/systems to compile information for presentation or distribution
Identifies new uses of current systems or use of new applications to enhance the management capabilities of projects
Expertise in clinical aspects of regulatory submission procedures, e.g. NDA, CTD, IDE

Job Responsibility

Lead the development and execution of clinical strategies and clinical research programs that enable Baxter’s product innovation and market adoption
Drive clinical planning, study execution, regulatory compliance, and cross‑functional collaboration while overseeing CROs, study sites, budgets, and timelines
Provide leadership to the clinical affairs team, ensuring high‑quality study operations, safety oversight, and successful delivery of clinical evidence supporting Baxter’s global portfolio
Gather business priorities for both pre-market (approval) and post market (evidence) needs for clinical research
Engage collaboratively with Medical Affairs, Marketing, Reimbursement, and R&D resources as required as inputs for priority needs and to advise the execution strategy
Develop strategy and make recommendations for approaches to meet goals for technology feasibility, product validation, claims substantiation or content supporting market adoption
Responsible for the identification and management of necessary resources to successfully initiate and complete clinical trials
Lead Clinical Study Execution team(s) to develop clinical strategies (and project plan) to efficiently manage the project(s) and maintain regulatory compliance
Lead team members, contractors, and deliver the following directly or by leading others

What we offer

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
Paid parental leave
Commuting benefits

Fulltime

Director, Clinical Affairs

Location

United States , Skaneateles Falls

Salary:

208000.00 - 286000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

BA/BS in scientific discipline with minimum of 10+ years clinical operations experience (pharmaceutical, biotechnology or medical device industry
medical device preferred)
Expertise in ICH/GCP, ISO 14155, US Federal Food and Drug Administration and European Regulatory Authority requirements
Well-established knowledge in overall product development process from Phase 1 through Phase 4 for medical device trials, including software validation
Expert knowledge of research objectives, protocol design, and data collection standards
Experience reviewing monitoring reports
High experience/proficiency with clinical operations systems including EDC, CTMS, and eTMF
Able to monitor performance of team in maintaining system updates to allow for senior management reports
Applies current applications/systems to compile information for presentation or distribution
Identifies new uses of current systems or use of new applications to enhance the management capabilities of projects

Job Responsibility

Lead the development and execution of clinical strategies and clinical research programs that enable Baxter’s product innovation and market adoption
Drive clinical planning, study execution, regulatory compliance, and cross‑functional collaboration while overseeing CROs, study sites, budgets, and timelines
Provide leadership to the clinical affairs team, ensuring high‑quality study operations, safety oversight, and successful delivery of clinical evidence supporting Baxter’s global portfolio
Gather business priorities for both pre-market (approval) and post market (evidence) needs for clinical research
Engage collaboratively with Medical Affairs, Marketing, Reimbursement, and R&D resources
Develop strategy and make recommendations for approaches to meet goals for technology feasibility, product validation, claims substantiation or content supporting market adoption
Responsible for the identification and management of necessary resources to successfully initiate and complete clinical trials
Lead Clinical Study Execution team(s) to develop clinical strategies and project plan
Partner with Medical Monitor, Regulatory Affairs and Commercial to prepare a clinical plan
Facilitate preparation of protocols including study design, case report forms, study procedures

What we offer

Medical and dental coverage start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP) with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
Paid parental leave
Commuting benefits

Fulltime

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Clinical Success Director

Job Description

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