Team Lead - Clinical Affairs Job at Brainlab (Munich)

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

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, 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

Vice President, Enzyme Therapies, Clinical Development

The Vice President, Enzyme Therapies, Clinical Development is the head of Resear...

Location

United States , San Rafael

Salary:

307840.00 - 461760.00 USD / Year

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

M.D. or M.D./PhD degree
15+ years of clinical research and development experience within pharmaceutical/biotech industry
8+ years in a leadership role leading and managing teams
Significant experience in late-stage clinical development within the biopharma industry
Demonstrated leadership of successful regulatory filings (NDA/BLA/MAA) for global clinical programs
Oversite of clinical development of a therapeutic area or multiple assets within a disease area
Excellent track record in building and growing high-performing teams
Excellent leadership and organizational skills, written and verbal communication skills, and interpersonal skills
Ability to effectively influence diverse internal and external customer groups at various levels
Demonstrated strategic and critical thinking, dynamic leadership, and team-building skills

Job Responsibility

Lead the development and execution of the Enzyme Therapies BU pipeline strategy
Oversee strategic selection and prioritization of assets
Build and lead a high-performing, cross-functional development strategy team
Partner with clinical, regulatory, commercial, medical, portfolio strategy, and business development functions
Drive late-stage clinical development, study design, and execution for pivotal and post-marketing studies
Work closely with business development to evaluate and integrate external innovation opportunities
Provide scientific and medical leadership for global regulatory filings and interactions
Serve as the primary communication liaison between the BU Leadership Team and R&D Leadership Team
Ensure key BU portfolio deliverables are planned, executed, and measured
Maintain strong relationships with investigators, regulators, key opinion leaders, and other external stakeholders

What we offer

Discretionary annual bonus
Discretionary stock-based long-term incentives
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans

Fulltime

Regulatory Affairs Manager

The RA Manager supports Global Reg Teams in the development and execution of glo...

Location

United States

Salary:

51.00 - 75.00 USD / Hour

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

Degree in health or life sciences, including chemistry, molecular biology, or similar. PhD preferred, Masters/Bachelors acceptable with relevant experience
4+ year experience
Nonclinical / Clinical Regulatory Affairs experience preferred

Job Responsibility

Support the development of the nonclinical / clinical regulatory strategy and plan
Assist with selected planning, document development and meeting execution activities in preparation for HA meetings / interactions
Participate in Study Execution Teams for assigned products and identify relevant regulatory considerations for discussion with RNC Lead
Collaborate with CROs that are contracted to perform regulatory submissions/HA interactions for global clinical trials
With oversight by RNC lead, develop and coordinate the core nonclinical / clinical content of regulatory submissions
Responsible for ensuring high quality nonclinical/clinical content that adheres to regulations and guidances
Lead the maintenance of IND/CTAs throughout the life of the studies (e.g., annual reports)
Assist with the preparation of HA submission packages including but not limited to compiling relevant materials (Protocols, Annual Reports, Briefing Books, etc.) and completing regulatory documents/forms for internal review
Collaborate with Reg PM to create and align submission timelines
Collaborate with Reg Ops to provide final documents and QC published outputs for submissions to HA

What we offer

discretionary annual bonus
discretionary stock-based long-term incentives
paid time off
company-sponsored medical, dental, vision, and life insurance plans

Medical Affairs Lead

Medical Affairs Lead is responsible for the overall direction, management, perfo...

Location

China , Beijing; Shanghai

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

GLP-1 experience
Medical affairs experience on new launch and R&D collaboration
Clinical practice background as physician, oncologist, or others
BD and CSO partnership experience
Team management, 5 years on 2-layer team and large team
Experience on tough situation, with strong resilience and good performance
Knowledge of health care economics and its impact on medical decision making
Professional demeanor & excellent interpersonal skills when dealing with external customers/internal colleagues
Proven strategic thinking skills and ability to interpret and implement strategic directions
Creativity, resourcefulness, high energy and flexibility

Job Responsibility

Responsible for the overall direction, management, performance, and long term development of the Medical Affairs Team
Lead the team to develop effective full lifecycle medical strategy and projects to improve local healthcare environment and disease management, to maximize pfizer products’ medical value to the patients and the society
Lead the team to be pro-actively involved in all aspects of product’s development and subsequent business initiatives through cooperation with various business teams, e.g., Marketing teams, Business Group/Sales groups, BD team, etc
Proactively participate in the strategic business planning process, and lead the medical session with valuable inputs to help business teams to achieve maximum potential of products
Interact with global Medical Affairs and other Regional Medical Affairs to maximize the resource utilization and partnership
Provide medical input to platform departments and other functional groups in Medical who need Medical support for the therapeutic areas and the products
Build up the strategic partnership or project-based interaction between Key Opinion Leaders (KOLs), Academia and Pfizer
Continuously explore new opportunities to maximize the value of medical affairs team to business, and enhance Pfizer’s scientific image in the academic society, as well as the government authorities
Ensure the Company’s adherence to high medical standards of business initiatives, including promotional materials, ensuring medical compliance in educational activities
Provide medical input to policy development in dealing with healthcare professionals

Fulltime

Senior Clinical Scientist

The Senior Clinical Scientist role is suited to scientifically minded candidates...

Location

United States , Salt Lake City

Salary:

Not provided

Blackrock Neurotech

Expiration Date

Until further notice

Requirements

Ph.D. in Neuroscience, Biomedical Engineering, or a related field
Proven expertise in experimental design, data analysis, and scientific communication
Demonstrated experience working across pre-clinical and clinical research settings, with the ability to translate study objectives into executable protocols and comparable datasets across settings
Experience developing and/or executing acute and/or intraoperative electrophysiology studies
Strong analytical skills and proficiency with statistical software and data visualization tools, including analysis of electrophysiology and device performance data
Excellent written and verbal communication skills
Ability to work independently and as part of a collaborative team

Job Responsibility

Lead and manage clinical research projects, collaborating with pre-clinical and multidisciplinary teams, and ensuring alignment with company goals and regulatory requirements
Partner between clinical and pre-clinical teams to develop and execute acute and intraoperative electrophysiology studies, including defining endpoints, coordinating execution workflows, and ensuring high-quality data acquisition
Support and/or coordinate hardware testing in the context of acute/intraoperative clinical studies (e.g., test planning, setup verification, troubleshooting, and structured capture of outcomes to inform development decisions)
Analyze and interpret complex data sets, providing actionable insights to guide BCI development
Collaborate with cross-functional teams, including engineering, regulatory, and clinical affairs, with emphasis on bridging clinical and pre-clinical stakeholders to align study execution and hardware testing needs
Prepare and present scientific reports, publications, and presentations to internal and external stakeholders
Stay current with advancements in neurotechnology and related fields to inform research strategies
Mentor and provide guidance to junior scientists and other team members

Fulltime

Associate Vice President, Clinical Data Management

The Associate Vice President, Clinical Data Management is a member of the Global...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s or master’s degree with 25+ years of data management experience
10 to 15 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Experience within clinical data management, regulatory compliance, and strategic leadership within a pharmaceutical, biotech, or CRO environment
Expertise in GCP, ICH, FDA, EMA regulations, data governance, and clinical trial data standards (CDISC, SDTM)
Experience within cross-functional collaborations, leadership, and strategic planning skills, ensuring operational excellence and compliance while driving innovation in data management to support Amgen’s global clinical development efforts
Expertise in AI/ML-driven data management solutions, automation, and advanced analytics
Understanding of clinical data standards (CDISC, SDTM, ADaM)
Experience leading regulatory submissions, including NDA/BLA/MAA filings and advisory committee interactions
Proven ability to drive organizational change, optimize processes, and implement lean principles in clinical data management
Cross-functional collaboration experience with clinical operations, regulatory affairs, biostatistics, and R&D teams

Job Responsibility

Develop and drive the global data management strategy in alignment with clinical development objectives and corporate goals
Provide strategic and operational leadership to the Clinical Data Management (CDM) function across all clinical programs and phases
Lead innovation initiatives, including the implementation of development integration programs and the adoption of cutting-edge technologies to enhance data workflows
Represent Clinical Data Management in executive leadership discussions, regulatory interactions, and industry forums
Establish and enforce robust clinical data governance models, policies, and risk mitigation strategies to ensure quality and compliance
Make final decisions regarding standard operating procedures (SOPs), CDM best practices, and process optimization
Engage key stakeholders and ensure timely resolution on critical data integrity and regulatory compliance issues
Serve as the primary CDM representative during regulatory inspections and audits, with responsibility for final decisions on findings, responses, and corrective actions
Influence cross-functional clinical development, operational, and regulatory strategies through data-driven insights and analytics
Partner closely with Clinical Program Operations, Regulatory, Biostatistics, and R&D to ensure seamless integration and alignment of clinical data

Team Lead - Clinical Affairs

Brainlab

Location:
Germany , Munich

Category:
Health and Beauty

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
February 14, 2026

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