Clinical Lead - Pre Assessment Job at Circle Health Group (Birmingham)

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

Minimum: 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
Clinical Strategy Development: 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
Conduct Clinical Research: 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
Clinical Plan - Partner with the Medical Monitor, Regulatory Affairs and Commercial to prepare a clinical plan for each project. This includes preparing timelines and budgets for the clinical program
Clinical Trial Protocols - 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), 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, and paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)

Fulltime

Director of Quality Assurance, Clinical

Responsible for leading in the development, implementation and maintenance of QA...

Location

United States , Berkeley

Salary:

220000.00 - 235000.00 USD / Year

Caribou Biosciences

Expiration Date

Until further notice

Requirements

Undergraduate or graduate degree(s) in Biological Sciences, Chemistry, or related Science discipline
At least 15 years of experience in clinical quality assurance (GCP, GLP and PV) in cell & gene therapy/biotechnology and/or pharmaceutical industry
Experience working in biologics is strongly preferred
Subject Matter Expert (SME) working knowledge on current interpretation/implementation of United States Code of Federal Regulations, ICH Guidelines and other local government regulatory requirements governing clinical research
Proven track record in developing and implementing quality systems and processes in a clinical setting
Expertise in creating and executing audit plans outlining all service providers (vendor) audits, clinical investigator site audits, CSV audits and process audits
Advanced knowledge of Quality Assurance principles, concepts, industry practices, and standards
Prior GLP experience with quality oversight and auditing studies/vendors (preferred)
Excellent verbal and written communication skills
Ability to lead cross-functional teams and independently prioritize work

Job Responsibility

Compliance Oversight: Ensure that all clinical trial activities comply with guidelines and international regulations (e.g., ICH-GCP and ICH-PV), and applicable laws
Documentation Review: Conduct thorough reviews of study-related documentation, including protocols, investigator brochures, informed consent forms, and CSRs, to verify compliance with GCP requirements
Provide Clinical Quality Assurance (GCP) strategic and technical leadership and Subject Matter Expertise (SME) to clinical study teams
Partner with the teams to effect appropriate and timely documentation of quality event management, including CAPA plans in support of product pipeline
Plan and oversee activities in support of regulatory submissions and inspections
Lead GCP Inspection Readiness efforts, ensure implementation and prepare internal and external teams for Pre-Approval Inspections (PAI)
Implement, monitor, and promote best practices of all Quality Assurance Systems to ensure compliance with relevant FDA, EU and ROW regulations/directives/requirements and ICH guidelines
Quality Management System (QMS): Maintain and enhance Caribou’s QMS by implementing processes and procedures that ensure consistent adherence to GCP, GLP and PV standards throughout the clinical trial lifecycle
Develop and implement the appropriate suite of Standard Operating Procedures (SOPs), quality manuals, policies, and other related quality documents
Ensure that these systems are effectively communicated, understood, and followed by relevant stakeholders

What we offer

Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees
Generous paid vacation time, in addition to company-observed holidays
Excellent medical, dental, and vision insurance
401(k) retirement savings plan, which includes matching employer contributions
Employee stock purchase plan (ESPP)
Tuition reimbursement program

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
Expertise in clinical aspects of regulatory submission procedures, e.g. NDA, CTD, IDE
Expertise in project management practices
Ability to provide positive direction to team as well as identify problems/issues and work towards resolution
Exceptional organizational and team leadership skills

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
Clinical Strategy Development: 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
Conduct Clinical Research: 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
Clinical Plan - Partner with the Medical Monitor, Regulatory Affairs and Commercial to prepare a clinical plan for each project. This includes preparing timelines and budgets for the clinical program
Clinical Trial Protocols - Facilitate preparation of protocols including study design, case report forms, study procedures. Develop and complete enrollment feasibility evaluations based on protocol synopsis. Draft informed consents based on study and regulatory requirements

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, and paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)

Fulltime

Lead Outpatient Mental Health Supervisor

Ellie Mental Health has arrived in Quincy, MA and we’d love to have you join our...

Location

United States , Quincy

Salary:

80000.00 - 110000.00 USD / Year

Ellie Mental Health

Expiration Date

Until further notice

Requirements

A master’s degree in one of the behavioral sciences or related fields from an accredited college or university
Clinical licensure (LMFT, LMHC, LICSW, PsyD, etc.)
Experience with completing assessments, treatment plans and clinical case notes
Effective written and verbal communication skills
Ability to demonstrate and model stable, appropriate boundaries with clients
Ability to complete and submit documentation of services and other documents in a timely manner
Comfort and familiarity working with a diverse client base
Proficient in the use of Office 365 and Electronic Health Record systems (Valant experience a plus!)

Job Responsibility

Supervise and mentor pre-licensed therapists
Evaluate clinical presentations, diagnose, create and implement treatment plans and treatment plan reviews, complete ongoing documentation and case notes according to company policy
Provide excellent customer service for clients and collaborate with a dynamic team to further the mission of filling gaps in our community
Utilize creativity in interventions to help clients achieve and exceed goals
Prepare and submit individual documentation for each session per company guidelines and protocol
Coordinate services with case managers, families, work personnel, medical personnel, other Ellie staff, and school staff as needed
Attend and participate in all clinical staff meetings and trainings

What we offer

401(k)
401(k) matching
Dental insurance
Flexible schedule
Health insurance
Paid time off
Competitive salary
Free uniforms
Opportunity for advancement
Training & development

Fulltime

New

Clinical Nurse Specialist, Orthopaedics

Blackrock Health Hermitage Clinic is a private hospital providing a full range o...

Location

Ireland , Lucan, Co. Dublin

Salary:

Not provided

Blackrock Health Hermitage Clinic

Expiration Date

Until further notice

Requirements

Be registered in the general division of the Register of Nurses maintained by NMBI
Have at least five years recent relevant post-registration nursing experience (full-time or equivalent hours part-time) in an acute hospital setting and a minimum of two years nursing experience in Orthopaedic Nursing
Have acquired a level 8 post registration Quality and Qualifications Ireland (QQI), National Framework of Qualifications (NFQ) major academic award relevant to the specialist area- Orthopaedic Nursing (or similar)
Clinical Skills
Management skills
Leadership skills
IT skills
Quality focus
Risk Management
Clinical audit

Job Responsibility

Plan and initiate care and treatment modalities within agreed protocols to achieve patient centred outcomes and evaluate their effectiveness
Utilize assessment skills and techniques to determine each patient/family needs
Plan all care in collaboration with the patient
Provide specialist advice to patients on appropriate products to meet their needs
Liaise as appropriate with other members of the multidisciplinary team (MDT) regarding any aspect of patient care
Develop, document and update care, discharge and teaching plans and documentation as necessary
Evaluate the care/information given and reassess accordingly
Co-ordinate and track the completion of the patient reported outcome measures (P.R.O.M.S.) at the pre and post-operative assessments, review the patient post-operatively at 6 months, 2 years, 5 years, 10 years, 15 years and 20 years and record any complications in accordance with the Irish National Orthopaedic Register (INOR) template
Monitor and review data input from this hospital
Attend to the routine calls from patients by the use of a telephone helpline, provide timely specialist advice or consultation as appropriate

What we offer

Competitive salary
Onsite parking
Pension
Annual bonus*
Discounted café
Sports and Social club
Employee Assistance Programme
Discounted onsite pharmacy

Fulltime

Oncology Early-Stage Clinical Scientist

You will lead and coordinate the development of multiple studies of novel biolog...

Location

United States , Cambridge; La Jolla; Bothell; Groton; New York City

Salary:

176600.00 - 282900.00 USD / Year

Pfizer

Expiration Date

Until further notice

Requirements

Relevant PhD or PharmD and a minimum of 5 years of experience in a similar role in industry/CRO
MS and a minimum of 7 years of experience in a similar role in industry/CRO
BA/BS and a minimum of 10 years of experience in a similar role in industry/CRO
Clinical Research experience in Phase 1 in Oncology, on the side of the sponsor leading studies
Experience in or strong understanding of Oncology Drug Development especially in Early Development
Strong knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA, EMA, and global regulations
Strong scientific writing skills and communication skills (written and verbal)
Clinical document writing experience (e.g., protocol, ICD, IB, IND), as well as understanding complex data analysis
Track record of scientific productivity as evidenced by publications, posters, abstracts and/or presentations
Experience working with and solid understanding of related disciplines, e.g., Clinical Operations, Data Management, Safety, Biostatistics, Regulatory, Study Management, Pre-Clinical, Pharmacology, Quality Assurance

Job Responsibility

Partner closely with the Global Development Lead (GDL) in the execution of the clinical development strategy and plan for the assigned molecule(s)/indication(s)
Responsible for scientific leadership and execution of clinical studies and delivering on innovative clinical study designs, high quality trial execution, safety assessment and interpretation of clinical study results
Support execution for all FIH programs through proof-of concept
Set the clinical data review strategy, ensure quality data and conduct review of emerging clinical data and trends
review and query data
present and discusse relevant data to appropriate teams, governance bodies, and other internal and external stakeholders
Conduct data review, analysis and interpretation of clinical trials data together with the GDL, Clinical Safety, and Biostatistics
Serve as technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contractors
Support and assist in the development of publications, abstracts, and presentations
May sit on project teams to support clinical development implementation and contribution to key development milestones, e.g. start-up and delivery of ESoE and PoC trials

What we offer

Eligibility for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% of the base salary
Eligibility to participate in our share based long term incentive program
401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
Paid vacation, holiday and personal days
Paid caregiver/parental and medical leave
Health benefits to include medical, prescription drug, dental and vision coverage
Relocation assistance may be available based on business needs and/or eligibility

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
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
Expertise in clinical aspects of regulatory submission procedures, e.g. NDA, CTD, IDE
Expertise in project management practices
Ability to provide positive direction to team as well as identify problems/issues and work towards resolution
Exceptional organizational and team leadership skills

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
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), 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
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

Fulltime

Research Scientist II - Toxicologist

Lead in ensuring product compliance and patient safety through cutting-edge toxi...

Location

United States , Round Lake, Illinois

Salary:

120000.00 - 165000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

BS with 8+ years, MS with 6+ years, or PhD with 2+ years of relevant experience in R&D and/or GLP environments
Medical Device experience strongly preferred
Solid understanding of national and international non-clinical safety and biological evaluation regulations, including Good Laboratory Practices (GLP)
Direct experience working with regulatory bodies such as the US-FDA, EU Notified Bodies, and other national or international reviewers
A strong track record of presenting at scientific conferences and authoring/co-authoring published articles in peer-reviewed journals
Demonstrated ability to advance new product development projects and provide innovative non-clinical solutions for pharmaceutical and medical device challenges
Experience in a GLP and/or R&D environment, with a solid understanding of project management principles

Job Responsibility

Provide technical and strategic input to project teams
Lead in authoring pre-clinical sciences and toxicology deliverables, including non-clinical testing plans and toxicological risk assessments
Plan and manage complex projects
Assess technical and scientific information, identify deficiencies, and design innovative solutions to mitigate risks
Support innovation initiatives by providing technical direction
Participate in standards organizations and regulatory committees
Work closely with R&D, Clinical, Medical Affairs, Regulatory Affairs, Quality, Manufacturing, and Environmental Health and Safety teams
Articulate the Pre-Clinical Toxicology vision, goals, and performance to project teams
Establish and nurture professional networks both internally and externally

What we offer

Medical and dental coverage
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
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

Fulltime

Clinical Lead - Pre Assessment

Circle Health Group

Location:
United Kingdom , Birmingham

Category:
Nursing

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
March 21, 2026

Expiration:
April 12, 2026

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