Team Lead - Clinical Affairs Job at Brainlab (Munich)

Vice President of Medical Affairs and Clinical Development, Oncology

We are hiring a Vice President of Medical Affairs, Oncology to lead the executio...

Location

United States , Menlo Park

Salary:

269282.00 - 290402.00 USD / Year

BillionToOne

Expiration Date

Until further notice

Requirements

M.D. degree required
must be a board-certified Medical Oncologist
M.D./Ph.D. strongly preferred
5+ years of leadership experience in medical affairs and clinical development within oncology
Proven track record of designing and executing clinical studies for diagnostics and/or therapeutics
Deep knowledge of medical education, payer evidence requirements, and regulatory expectations
Exceptional scientific communication and cross-functional leadership skills
Thrives in fast-paced, entrepreneurial environments

Job Responsibility

Lead the MSL function to drive provider engagement, medical education, and scientific communications in support of commercial and access efforts
Design and execute clinical trials that generate robust evidence for guideline inclusion, regulatory milestones, and payer coverage
Oversee the generation of clinically actionable insights and high-impact publications based on study and real-world data
Collaborate closely with Product, Commercial, R&D, Market Access, and Regulatory teams to ensure that medical strategy supports business outcomes
Hire, mentor, and develop high-performing leaders across the medical, clinical, and translational teams

What we offer

Working alongside brilliant, kind, passionate and dedicated colleagues, in an empowering environment, toward a global vision, striving for a future in which transformative molecular diagnostics can help millions of patients
Open, transparent culture that includes weekly Town Hall meetings
The ability to indirectly or directly change the lives of hundreds of thousands patients
Multiple medical benefit options
employee premiums paid 100% of select plans, dependents covered up to 80%
Extremely generous Family Bonding Leave for new parents (16 weeks, paid at 100%)
Supplemental fertility benefits coverage
Retirement savings program including a 4% Company match
Increase paid time off with increased tenure
Latest and greatest hardware (laptop, lab equipment, facilities)

Fulltime

Senior Manager - Clinical Affairs

Define and lead the global Clinical Affairs strategy for Brainlab’s global surge...

Location

Germany , Munich

Salary:

Not provided

Brainlab

Expiration Date

Until further notice

Requirements

Advanced scientific, medical or technical degree (PhD, MD, or equivalent preferred)
Extensive experience in Clinical Affairs, Clinical Research within the medical device industry
Strong background in clinical and regulatory requirements for Class I–III medical devices
Demonstrated leadership experience, including managing international or cross-functional teams
Several years of experience in Clinical Affairs, Clinical Research and/or R&D within the medical device industry
Clinical and regulatory background for Class I to Class III medical devices
In-depth knowledge of EU MDR, FDA regulations and Good Clinical Practice
Hands-on experience in clinical studies, clinical evaluations and regulatory submissions for medical devices
Ability to translate clinical research into scientific marketing content
Excellent stakeholder management, communication, and project leadership skills

Job Responsibility

Define and lead the global Clinical Affairs strategy for Brainlab’s global surgery portfolio, ensuring alignment with product, regulatory and commercial objectives / teams
Lead and develop an international Clinical Affairs team responsible for clinical evaluation, clinical research and scientific marketing communication
Ensure clinical compliance with EU MDR, FDA and other regulatory requirements
Build and maintain a strong clinical network of investigators, key opinion leaders and research partners
Act as Process Owner for clinical evaluation and validation, training authors and evaluators to ensure regulatory compliance
Partner closely with R&D, Product Management, Marketing, Sales and Quality Management on the strategy and to translate clinical insights into product innovation and market differentiation
Bridge clinical research and scientific marketing by translating evidence into credible, high-impact scientific and educational content
Ensure GDPR compliance in clinical collaborations
Define and manage clinical studies and investigations to support product innovation and regulatory approvals
Represent the company in communications with regulatory authorities related to clinical strategy, investigations and submissions

What we offer

30 vacation days, plus December 24th and December 31st
Flexible working hours
Hybrid work model within Germany
Bike leasing via cooperation partner "BikeLeasing"
Parking garage and safe underground bike storage
Award-winning subsidized company restaurant and in-house cafes
Variety-rich fitness program in our ultra-modern 360m2 company gym
Regular after work, team, and company events
Comprehensive training and continuing education opportunities

Fulltime

Head of Regulatory Affairs

The Head of Regulatory Affairs is responsible for providing strategic leadership...

Location

India , Chennai

Salary:

Not provided

Randstad

Expiration Date

February 15, 2026

Requirements

Advanced degree (PharmD, PhD, MD, or MSc) in Life Sciences, Pharmacy, or a related field
Minimum of 10-15 years of experience in Regulatory Affairs
At least 5 years in a leadership role within a CRO or biopharmaceutical organization
Proven experience in global regulatory submissions and interactions with major health authorities (FDA, EMA, MHRA, CDSCO, etc.)
In-depth understanding of clinical development, GCP, and ICH guidelines
Strong track record in managing teams and leading complex regulatory projects across multiple therapeutic areas
Exceptional leadership, communication, and negotiation skills
Ability to translate complex regulatory requirements into practical strategies
Strong client relationship management and presentation abilities
High attention to detail with strong organizational and problem-solving skills

Job Responsibility

Develop and implement the CROs regulatory strategy aligned with corporate goals and client needs
Serve as the primary regulatory expert and advisor to senior management and project teams
Lead and mentor the Regulatory Affairs team
Build and maintain relationships with global regulatory agencies and industry associations
Oversee preparation, review, and submission of regulatory documents including INDs, NDAs, BLAs, ANDAs, IMPDs, CTAs, and other filings
Ensure regulatory compliance in all clinical trials
Develop and maintain global regulatory intelligence
Support clients with regulatory strategy, gap analysis, and submission planning
Establish and oversee systems for document management, tracking, and reporting of regulatory submissions
Partner with Business Development and Project Management teams to provide regulatory input during proposal development and client meetings

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

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

New

Medical Director, Hematology

Lead the science that shapes tomorrow's hematology breakthroughs. Proclinical is...

Location

United States , Boston

Salary:

Not provided

Proclinical

Expiration Date

Until further notice

Requirements

Medical degree (MD or equivalent), ideally with Hematology/Oncology fellowship training
Strong interest in developing innovative therapies and impacting patient populations
Experience in clinical research or drug development, spanning Phases I through IV, is preferred
Medical and scientific expertise in hematology or oncology is advantageous
Excellent collaboration and communication skills to work effectively with diverse teams and stakeholders

Job Responsibility

Lead clinical deliverables for a designated section of a clinical program with minimal supervision
Manage operational aspects and ensure successful execution of the clinical program in partnership with global line functions, Clinical Scientists, and Clinical Operations teams
Support and occasionally lead interactions with external collaborators, including regulatory authorities, key opinion leaders, advisory boards, and patient advocacy groups
Collaborate with internal teams such as Research, Early Clinical Development, Medical Affairs, Marketing, and HEOR
Contribute to Global Clinical Development training programs, author or review clinical SOPs, and participate in taskforces or panels to shape clinical development strategies

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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