Director, Clinical and Safety Quality Job at Alfasigma (Mechelen)

Medical Director, Clinical Development

We are seeking an experienced, highly motivated Medical Director, Clinical Devel...

Location

United States , Waltham; San Diego

Salary:

205000.00 - 250000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

2+ years of industry experience in clinical development, preferably in a biotech or small pharma environment
Hands-on experience designing and executing clinical trials
Experience with IND submissions and global regulatory filings
Understanding of GCP, clinical trial design, regulatory requirements, and safety monitoring
Excellent written and verbal communication skills, including protocol and regulatory document writing
Demonstrated ability to engage with KOLs, investigators, and cross-functional teams
Can work independently
self-starter attitude
MD or equivalent is required

Job Responsibility

Responsible for medical monitoring/reporting and safety activities
Provide medical leadership in the design, planning, and execution of clinical development strategies across multiple studies
Acts as the medical contact at the company for clinical/medical issues
Interprets, reports, and prepares oral and written results of product research, in concert with senior clinical personnel
Serve as the medical expert for assigned assets studies
Contribute to regulatory interactions and strategy, including IND/CTA submissions and briefing packages
Collaborate and work closely with Clinical Operations to ensure appropriate site selection, patient recruitment strategies, and high-quality trial execution
Oversee and support data interpretation, analysis, and clinical study reports
Work closely with internal stakeholders, including Regulatory, Safety, CMC, and Translational Science teams
Partner with external collaborators, KOLs, CROs, and investigators

What we offer

Comprehensive health benefits and tax-advantaged savings accounts
Flexible time off, 13 paid holidays, and a companywide year-end shutdown
Monthly wellness stipend
Generous 401(k) match
Disability and life insurance

Fulltime

Senior Medical Director, Clinical Development

Cabaletta is seeking an experienced, highly motivated hands-on physician leader ...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

D., M.D./Ph.D. degree or equivalent required
Board Certification, Board Eligibility, or clinical experience in the field of Rheumatology and/or Immunology highly desirable
7+ years of experience in clinical research, including the design and execution of complex clinical trials, with a pharmaceutical or biotech company
Experience with or exposure to the development of adoptive cell therapies or biologic therapies is desirable
Experience with Health Authority interactions and submission of clinical regulatory documents is desirable
Strong written and verbal communication skills
ability to easily engage with investigators and key external experts
and ability to effectively present at conferences, advisory meetings, and other public for a
Engaged, hands-on, independent, and goal-oriented mentality
willingness to work in highly dynamic work environment

Job Responsibility

Provide medical leadership for various programs from first-in-human studies through registrational studies
Formulate study designs, lead protocol development, partner with internal cross-functional teams in study start-up activities, and collaborate with clinical investigators, key external experts, and Health Authorities
Participate in direct, hands-on involvement in all aspects of study conduct clinical activities, working with clinical operations, including data review, analysis, and reporting that conform to the ethical, safety, and quality standards of Cabaletta, GCP, and Health Authorities
Become an expert and remain current in the relevant therapeutic areas and in the field of cell and gene therapy through review of the scientific literature, interactions with key external experts, and attendance at relevant scientific meetings
Actively contribute during Health Authority interactions
Review available preclinical data that could inform the design of future clinical trials
Present at site evaluation and site initiation visits as applicable
In partnership with relevant cross-functional team members, actively engage in the preparation of Clinical Study Reports, Annual Reports and other safety reports, Health Authority pre-meeting packages, Investigator Brochures, periodic clinical reports, and BLA submission documents
Collaborating with cross-functional groups, formulate publication strategy including active participation in authoring, preparation and review of manuscripts, conference abstracts and presentations and other external presentations of clinical data

What we offer

health and retirement, PTO, and stock option plans

Sr. Director, Clinical Scientist

The Sr. Director, Clinical Scientist plays a pivotal role in shaping the clinica...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Advanced degree (MS, Ph.D., Pharm.D., M.D., or equivalent) in a relevant scientific discipline preferred
7+ years of clinical development experience within biotech, pharmaceutical, or academic settings, with demonstrated leadership in advancing programs through early and late-stage development
Cell and gene therapy experience—particularly in CAR-T or T-cell–based modalities—strongly preferred
autoimmune disease experience highly desirable
Deep understanding of T-cell biology, immunology, and translational science principles relevant to cellular therapy
Proven ability to author and critically review clinical protocols, study reports, and regulatory documents, ensuring scientific integrity and compliance with ICH-GCP and global regulatory standards
Demonstrated skill in analyzing complex clinical data, conducting literature reviews, and synthesizing insights to inform program strategy
Exceptional scientific judgment, attention to detail, and analytical rigor
Strong communication and collaboration skills, with the ability to influence and partner effectively across cross-functional teams, investigators, and external experts
Highly organized with the ability to manage multiple priorities in a fast-paced, evolving environment.

Job Responsibility

Serve as the clinical science lead for assigned CAR-T programs, partnering with the Medical Director on the design, execution, and interpretation of clinical studies across all phases of development
Author and oversee key clinical documents — including protocols, amendments, informed consent forms, investigator brochures, clinical study reports, and regulatory submissions (e.g., INDs, CTAs, DSURs, BLAs/MAAs)
Review, analyze, and interpret emerging clinical data (safety, efficacy, PK/PD) to identify trends and issues, ensuring timely resolution through cross-functional collaboration
Conduct literature and competitive landscape reviews to inform study design, data interpretation, and program strategy
Provide ongoing data review to ensure study conduct aligns with protocol, patient safety standards, and data integrity expectations
Collaborate with the Medical Monitor to ensure awareness of key safety and efficacy findings, supporting SAE review, narrative development, and safety governance activities
Lead or support governance activities, including preparation and presentation of materials for Development, Executive, and Scientific Steering Committees, as well as oversight of external boards (e.g., DSMB, adjudication committees)
Contribute to and present scientific and clinical data internally and externally (e.g., investigator meetings, scientific conferences, regulatory interactions)
Serve as the clinical science representative on cross-functional development and study teams, providing scientific and strategic input to ensure cohesive execution
Mentor study team members and contribute to vendor oversight to ensure consistency, quality, and scientific rigor across all clinical deliverables

What we offer

health and retirement, PTO, and stock option plans

Senior Medical Director, Patient Safety and Quality

The Senior Medical Director, Patient Safety and Quality is a senior clinical lea...

Location

United States , Chicago

Salary:

184112.00 - 396550.00 USD / Year

CVS Health

Expiration Date

January 12, 2027

Requirements

Physician (MD or DO) or Nurse Practitioner (DNP preferred) with active, unrestricted license
Board certification in a primary care specialty (Family Medicine, Internal Medicine or Geriatrics)
Minimum of 5 years of clinical experience
demonstrated leadership experience in patient safety and/or quality improvement required, including leading programs, teams, or initiatives at scale
Strong knowledge of safety science, human factors, and systems-based approaches to care
Excellent communication, collaboration and change management skills

Job Responsibility

Strategic Leadership: Directly manage the Patient Safety team and establish organizational priorities for patient safety and quality initiatives
Accountable for organizational patient safety and quality performance
Build and sustain a culture of safety that promotes transparency, learning, and accountability across the organization
Provide national leadership for patient safety and quality strategies, priorities, and programs
Align safety and quality initiatives with Oak Street Health’s mission, enterprise strategy, regulatory requirements, and industry best practices
Partner with EPSO, HCD and Oak Street enterprise safety leadership to align priorities, share learnings, and drive systemwide improvement
Embed safety and quality principles into the care model, clinical workflows, team-based practices, and patient experience
Safety and Quality Governance: Serve as Co-Chair of the Clinical Quality Committee, overseeing quality strategy, outcomes measurement and improvement initiatives
Serve as Co-Chair of the Safety Committee, overseeing safety strategy, risk mitigation, event learning, and organizational response
Collaborate with the Pharmacy & Therapeutics (P&T) Committee to advance medication safety, optimize prescribing, and mitigate risk

What we offer

Affordable medical plan options
401(k) plan (including matching company contributions)
employee stock purchase plan
No-cost programs for all colleagues including wellness screenings, tobacco cessation and weight management programs, confidential counseling and financial coaching
paid time off
flexible work schedules
family leave
dependent care resources
colleague assistance programs
tuition assistance

Fulltime

New

Group Head of Quality & Patient Safety

Working as part of the Group Leadership team, this role will promote and sustain...

Location

Ireland , Dublin

Salary:

Not provided

Blackrock Health Hermitage Clinic

Expiration Date

Until further notice

Requirements

Post-Graduate qualification, or equivalent, in Quality & Patient Safety
Seven years post-graduate experience in acute care setting
Minimum 3-5 years’ experience at management level
High professional standards in relation to confidentiality and ethics
Working knowledge of relevant legislation
Claims Management experience
Experience managing and working collaboratively with multiple internal and external stakeholders, as relevant to this role
The requisite knowledge and ability (including a high standard of suitability and management ability) for the proper discharge of the duties of the office.

Job Responsibility

Champion a visible and inspiring leadership style that drives a culture of continuous quality improvement across the Group.
Develop and maintain a collaborative close working relationship with the Group Clinical Director.
Serve as a core member of the Group Clinical Governance Committee.
Participate in Group Executive and Hospital Leadership, communicating and working with multidisciplinary teams to embed quality as a shared organisational value.
Act as a key conduit, strengthening communication lines between Group Executive leadership and hospital clinical teams.
Lead the Group’s Data Protection function, ensuring ongoing compliance with data protection legislation and safeguarding all personal data under BHG’s control, while acting as the primary liaison with relevant internal departments and with third-party partners and stakeholders on data protection matters.
Support and work closely with the Medical Societies, Medical and Nursing Leadership and other clinical groups to ensure the highest clinical standards and evidence-based best practice.
Prepare and present clear, insight-driven reports to the Group Clinical Governance Committee and Board, and others as requested.
Provide reports to the Group and Hospital Clinical Directors on all aspects of Quality as required.
Represent Quality and Patient Safety on Group projects, such as EHR implementation and Sustainability.

Fulltime

Clinical Services Manager

The Clinical Services Manager (Regulatory and Quality Compliance Lead) will play...

Location

United Kingdom , Edgbaston or Glasgow

Salary:

55000.00 - 65000.00 GBP / Year

ACES Eye Clinic

Expiration Date

Until further notice

Requirements

Registered Healthcare Professional (NMC, HCPC, or equivalent)
Significant experience in clinical governance, regulatory compliance, or healthcare quality management
Strong understanding of CQC and UK regulatory frameworks, inspection preparation, and application processes
Skilled in data analysis, audit management, and quality reporting
Excellent communicator with the ability to engage confidently at senior and regulatory levels
Proactive, analytical, and organised, with a commitment to clinical excellence and patient safety

Job Responsibility

Lead on regulatory submissions, applications, and notifications to CQC and other UK regulators
Oversee governance administration, including Clinical Governance and Quality Committee meetings
Maintain and analyse the Quality and Compliance Dashboard to monitor clinical performance
Manage and report on incidents, complaints, investigations, and patient safety outcomes
Support and oversee compliance with mandatory training, clinical audits, and quality improvement plans
Undertake regular mock inspections and oversee our regulatory readiness framework
Liaise with commissioners, regulators, and internal stakeholders on matters of quality and compliance
Prepare comprehensive reports for the Director of Care and Quality and the Executive Team
Provide leadership and support to the Clinical Services Quality Team, promoting a culture of accountability and continuous improvement

What we offer

29 Days Annual leave
Private Medical Insurance
Free Eye surgery (LVC or IOL)
Discounts on other group procedures and goods

Fulltime

Clinical Services Manager

The Clinical Services Manager (Regulatory and Quality Compliance Lead) will play...

Location

United Kingdom , Glasgow; Edgbaston

Salary:

55000.00 - 65000.00 GBP / Year

ACES Eye Clinic

Expiration Date

Until further notice

Requirements

Registered Healthcare Professional (NMC, HCPC, or equivalent)
Significant experience in clinical governance, regulatory compliance, or healthcare quality management
Strong understanding of CQC and UK regulatory frameworks, inspection preparation, and application processes
Skilled in data analysis, audit management, and quality reporting
Excellent communicator with the ability to engage confidently at senior and regulatory levels
Proactive, analytical, and organised, with a commitment to clinical excellence and patient safety

Job Responsibility

Lead on regulatory submissions, applications, and notifications to CQC and other UK regulators
Oversee governance administration, including Clinical Governance and Quality Committee meetings
Maintain and analyse the Quality and Compliance Dashboard to monitor clinical performance
Manage and report on incidents, complaints, investigations, and patient safety outcomes
Support and oversee compliance with mandatory training, clinical audits, and quality improvement plans
Undertake regular mock inspections and oversee our regulatory readiness framework
Liaise with commissioners, regulators, and internal stakeholders on matters of quality and compliance
Prepare comprehensive reports for the Director of Care and Quality and the Executive Team
Provide leadership and support to the Clinical Services Quality Team, promoting a culture of accountability and continuous improvement

What we offer

29 Days Annual leave
Private Medical Insurance
Free Eye surgery (LVC or IOL)
Discounts on other group procedures and goods

Fulltime

Chief Medical Officer

The Chief Medical Officer, Canada, will be primarily responsible for ensuring Te...

Location

Canada , Toronto

Salary:

Not provided

Mirams Becker

Expiration Date

Until further notice

Requirements

MD or equivalent medical degree from an accredited institution
Licensed (or eligible for licensure) with the College of Physicians and Surgeons of Ontario (CPSO) or equivalent
Minimum of 10 years of clinical experience, including 5 years in a leadership or administrative role
Demonstrated success in medical governance, quality improvement, and physician engagement
Strong understanding of Canada’s healthcare system, hospital operations, and regulatory requirements
Experience with accreditation processes and performance metrics
Excellent communication, negotiation, and team-building skills

Job Responsibility

Develop and lead the enterprise-wide clinical strategy, ensuring alignment with organizational goals and innovation in care delivery
Oversee the clinical delivery of medical services, ensuring effective coordination with operational, and quality teams
Provide medical leadership for clinical governance by interpreting quality, safety, and compliance insights and ensuring appropriate clinical response
Set and maintain clinical policies, standards, and protocols that define appropriate medical practice and support consistent, high quality care across virtual platforms, in collaboration with quality and operational partners
Be accountable for the clinical quality and safety of care delivered by the provider network, in alignment with established clinical best practices, regulatory standards, and accreditation requirements
Review and act on quality, safety, and experience insights generated through organizational quality measurement and reporting processes, including addressing identified risks or performance issues
Ensure appropriate clinical response to quality findings, including provider feedback, coaching, remediation, and training through the clinical education function, and escalation or offboarding where required
Lead associate medical directors, clinical education, and provider network management teams to ensure effective delivery of clinical services
Recruit, credential, and manage a multidisciplinary provider network, including physicians, nurse practitioners, and allied health professionals
Provide clinical leadership and mentorship, fostering a culture of continuous learning and improvement

What we offer

Impactful, Connected Healthcare: Support millions of Canadians across the country with accessible care within rural regions & provincial health systems, at no cost to patients
Focus on Quality & Safety: Upholding the highest excellence of clinical quality standards is paramount to Teladoc Health
Collaborative, Supportive Network: Our diverse community is dedicated to transforming healthcare in Canada. Be a part of a growing team across Canada, that thrives on engagement, learning and growth
Our Work Truly Matters: Recognized as the world leader in whole-person virtual care, Teladoc Health uses innovative platforms to provide accessible care across the full continuum of care, at every stage in a person’s health journey
Growth and Innovation: We are growing rapidly - Come grow with us and support our expanding mission to make healthcare more accessible
Diversity and Inclusion: At Teladoc Health we believe that personal and professional diversity is the key to innovation. We hire based solely on your strengths and qualifications, and the way in which those strengths can directly contribute to your success in your new position

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Director, Clinical and Safety Quality

Job Description

Job Responsibility

Requirements

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