Senior Director – Global Regulatory Strategy Biologics Job at NonStop Consulting (Geneva)

Senior Director of Clinical Operations - sutacimig program

Hemab Therapeutics is seeking a Senior Director of Clinical Operations — a high-...

Location

United States , Boston

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

Bachelor's degree or higher in life sciences, biology, or related field
Strong command of ICH/GCP and international regulatory requirements
15+ years of clinical operations/clinical program management experience in pharmaceutical or biotech
Experience in rare disease, hematology, or bleeding disorders preferred
10+ years in a management or functional leadership role
Demonstrated ability to identify and implement operational process improvements
Proven track record of on-time, on-budget trial delivery in complex global programs
Excellent cross-functional collaboration and executive communication skills
Deep expertise in early and late-phase trial design and execution
Experience managing and optimizing CRO and vendor relationships

Job Responsibility

Drive innovative, creative and efficient trial design and optimization
Accountability for trial start, recruitment, enrollment and end to end execution
Represent Clinical Operations on the Asset Team and Clinical Strategy Subteam, contributing strategic and operational input on the sutacimig clinical development plan
Own end-to-end operational execution of clinical trials from protocol finalization through clinical study report
ensuring delivery on time, within budget, and to the highest quality standards
Drive rigorous planning and accountability across all functions: define milestones, manage risks proactively, and resolve operational issues with urgency and precision
Build and evolve fit-for-purpose processes, standards, and operating procedures that scale with the organization and reflect industry best practice
Establish and maintain transparent, data-driven reporting mechanisms to keep executive leadership and cross-functional teams fully informed on trial status, risks, and performance metrics
Lead budget ownership across the program including forecasting, tracking, and actively managing spend to ensure financial discipline without compromising quality or speed
Proactively identify and implement process innovations including novel trial designs, technology platforms, and decentralized/hybrid trial elements to accelerate timelines and improve patient access

Fulltime

Senior Director Immunology

The Senior Director Immunology will lead discovery, preclinical development, and...

Location

United States , Sioux Falls

Salary:

Not provided

SAB Biotherapeutics

Expiration Date

Until further notice

Requirements

PhD with 10+ years’ experience in Immunology or related field, with biotech/pharma industry experience required
Deep expertise in immunology, T-cell biology, autoimmune mechanisms, and therapeutic antibodies
Proven proficiency in clinical immunophenotyping, particularly advanced flow cytometry
Strong record of accomplishment in advancing immunology-focused therapeutics and leading translational/biomarker initiatives
Experience managing laboratory scientists and analytical teams
Skilled in molecular and cellular assay development within industry settings
Familiarity with global regulatory pathways (FDA, EMA, MHRA, TGA)
Highly collaborative, innovative, with strong written and spoken communication skills and ability to lead in a matrixed, distributed environment
High level of emotional intelligence and the demonstrated ability to be an effective listener with strong diplomacy and presentation skills
Previous experience meeting with and presenting to internal and external stakeholders to include, but not limited to BOD, investors, analysts and at industry conferences

Job Responsibility

Oversee the design, execution, and validation of biomarker discovery, flow-based immunophenotyping, and patient-stratification assays for clinical trials
Direct experimental planning and data analysis, ensuring high-quality data interpretation, reporting, and communication to internal stakeholders and governance bodies
Partner with translational, clinical, regulatory, and development teams to integrate biomarker and assay strategies into protocols, regulatory documents, and clinical plans
Provide strategic leadership across Research and Translational Immunology, guiding disease biology insights, mechanism-of-action studies, and biomarker-enabled clinical strategies
Participate in translational and biomarker planning for discovery through clinical stages, including immunophenotyping, pharmacodynamic analyses, and molecular/cellular profiling
Manage and collaborate with CROs, external vendors, and academic partners to support assay development, method innovation, and data generation
Foster an excellent research environment, supporting lab-based teams in culture, collaboration, operations, and safety
Represent Translational Science and Immunology internally and externally, presenting scientific findings and program progress. This includes presenting to investors, analysts and at industry conferences
Identify and pilot innovative technologies to enhance translational science and immunotherapy development
Ensure compliance with global regulatory standards (FDA/CBER, EMA, MHRA, TGA) and maintain awareness of scientific and technical advancements relevant to autoimmune drug development

Fulltime

Senior Director, Quality Control Analytical Sciences

We are seeking a Senior Director, Quality Control (QC) Analytical Sciences, to l...

Location

Salary:

245000.00 - 260000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

PhD in relevant discipline (e.g., analytical biochemistry or relevant field)
15+ years of QC experience with complex biologics, particularly monoclonal antibodies, spanning late-stage development and commercialization
Proven people leader with a growth mindset, willing to learn from others, and dedication to promoting a psychologically safe environment
Excellent communicator with an ability to present to and be understood by a variety of stakeholders and tailor message accordingly
Experience with regulatory filing preparation and messaging across global jurisdictions
Deep knowledge and understanding of relevant global regulatory guidance and requirements
Ability to keep pace with a fast-moving organization
Availability to participate in calls across multiple international time zones
Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
Ability and willingness to travel up to 30%

Job Responsibility

Lead QC Analytical Sciences team, responsible for QC activities for all pipeline programs including strategies for phase-appropriate method qualification, validation, and transfer for drug substance, drug product, and drug-device combination testing
in-process/release/stability testing
specification justification and maintenance
shelf-life management
and critical documentation
Partner with new and existing external QC testing labs and CDMOs, managing relationships and all relevant activities in collaboration with TechOps Program Management, Quality Assurance, and Manufacturing
Develop analytical regulatory strategies and prepare relevant Module 3 regulatory documents
Contribute to a mature QC infrastructure, implementing processes and procedures to support the development of therapeutic candidates in a GMP-compliant manner
Monitor data trends, troubleshoot QC method performance, and investigate OOT/OOS results

What we offer

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Fulltime

Global Study Director - Hematology/Oncology - Cell Therapy

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

United States; Canada , Montreal; Cary; Burlington; Blue Bell; Philadelphia; Pittsburgh

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research
Proven project management experience and training
At least 7 years of clinical trial experience
At least 3 years of experience in global study leadership and team leadership
Demonstrated clinical trial expertise in Hematology - Oncology
Extensive knowledge of ICH-GCP guidelines and clinical research regulatory requirements and experience in all phases of clinical study delivery
startup, maintenance and close out
Thorough understanding of the cross-functional clinical trial process eg. Data flow
Strong strategic and critical thinking abilities
Proven skillset and abilities in complex problem solving and decision-making

Job Responsibility

Lead and coordinate a cross-functional study team of experts in accordance with SDO/STOM and its roles, accountabilities and responsibilities framework (RACI) to ensure the clinical study progress as planned driving achievement of milestones according to timelines, budget and quality standards
Contribute to vendor/ESP selection activities at the study level, including bid defense, and lead operational oversight at the study level in order to ensure appropriate control over the vendor identification and selection
Assist the (Sr)GPD with the operational planning for upcoming clinical studies to establish required number of resources for study conduct, interfacing with other cross-functional partners and the TA as required
Collaborate with other functions to establish strategies and identify synergies aimed at increasing efficiency of global study teams (core and extended)
Lead and facilitate communication across functions and provide guidance and support to the core and extended study team members as needed and in accordance with study-specific communication plan
For outsourced studies, be the primary point of contact for the CRO Study Manager to ensure study delivery according to agreed upon timelines, budget and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study, in accordance with relevant SOPs and guidelines (e.g. description of services and transfer of obligations)
Provide operational expertise into and hold accountability for the development of essential study level documents (i.e. Clinical Study Protocol (CSP) through to Clinical Study Report (CSR)) in accordance with relevant
Ensure all external service providers (i.e. central laboratories, IXRS, ePRO, etc.) engaged at the study level are performing to contracted goals and timelines/budget and that adequate oversight is documented through planning & control activities
Develop and maintain relevant study plans (e.g. global study management plan and its relevant components such as study project plan SPP) including required input into study level quality and risk management planning (e.g. risk-based quality management, proactive risk and contingency plans, etc.), ensuring that the risk response strategies and issue escalation pathways are clear to the entire study team
Oversee study level performance against agreed upon plans, milestones and key performance indicators (KPIs, quality and operational) by using company tracking systems and project timelines (e.g. SPP, data flow metrics dashboard, CTMS or eTMF dashboard) and communicate any risks to timelines and/or quality to CPT, along with proposed mitigations

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Director, Clinical and Safety Quality

The Clinical & Safety Quality Director is responsible for establishing, leading,...

Location

United Kingdom , Mechelen

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Minimum 10–12 years of experience in pharmaceutical or biotech environments
At least 5 years in Clinical Quality Assurance and/or Pharmacovigilance Quality roles
Direct experience supporting Phase II–IV clinical development programs
Hands-on experience with regulatory inspections and health authority interactions
Experience in global or multi regional clinical development organizations is strongly preferred
Strong expertise in ICH-GCP and GVP requirements applicable to Sponsors
Demonstrated experience in clinical and/or pharmacovigilance quality oversight in a pharmaceutical company environment
Solid knowledge of outsourced clinical development models and CRO/vendor oversight
Proven ability to lead inspections, audits, and complex quality issue resolution
Strategic mindset with the ability to balance compliance, risk management, and operational agility

Job Responsibility

Define, implement, and maintain the Clinical and Safety Quality strategy aligned with global regulatory requirements (ICH-GCP, EU CTR, GVP Modules, FDA regulations)
Ensure effective oversight of Sponsor responsibilities for outsourced clinical and pharmacovigilance activities conducted by CROs, vendors, and partners
Lead the development, maintenance, and continuous improvement of Clinical and PV Quality Management Systems, including SOPs, standards, and governance processes
Plan and execute quality oversight activities, including: Clinical and PV audits (internal, vendor, affiliates, system, and study audits), Quality risk assessments, Vendor qualification and performance monitoring
Ensure inspection readiness and act as quality lead during regulatory inspections (EMA, FDA, MHRA, PMDA) related to clinical and safety activities
Oversee CAPA management, deviation handling, and root cause analysis related to clinical and safety quality issues
Provide quality input and decision support to clinical development teams, pharmacovigilance, regulatory affairs, and senior management
Promote a quality culture across clinical and safety organizations, supporting training, coaching, and awareness initiatives
Monitor regulatory intelligence and proactively adapt quality processes to evolving requirements (e.g. EU CTR, ICH E6(R3), digital trials)
Contribute to portfolio and program governance committees as quality subject matter expert

What we offer

Competitive salary
Comprehensive benefits
Extensive opportunities for professional growth and development

Service Line Lead – NAM Regulatory Development & Sciences

ProductLife Group is a global consulting and outsourcing partner to the life sci...

Location

United States

Salary:

200000.00 - 260000.00 USD / Year

Product Life Group

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a scientific discipline (life sciences, pharmacy, biology, chemistry, or related field)
Advanced scientific degree (PhD, PharmD, MD, or equivalent) preferred
20+ years of experience in regulatory affairs within the biotechnology and/or pharmaceutical industry
Demonstrated experience leading regulatory strategy and execution across early- and late-stage development through marketing authorization
Proven leadership experience in a consulting, professional services, or matrixed delivery environment
Extensive experience interacting with U.S. and ex‑U.S. Health Authorities and interpreting global regulatory frameworks
Deep expertise in global regulatory requirements, guidance, and legislation applicable to drug and biologic development
Ability to translate regulatory requirements into practical, executable development and submission strategies
Advanced understanding of regulatory submission strategy, Health Authority engagement, and regulatory risk management
Strong financial and operational acumen, including KPI management, forecasting, budgets, and utilization within consulting environments.

Job Responsibility

Own end-to-end performance and delivery of the Regulatory Development & Sciences Service Line
Drive service line KPIs including quality, timeliness, utilization, revenue, margin, and client satisfaction
Ensure consistent application of global standards, methodologies, SOPs, and quality requirements across all engagements
Act as senior escalation point for clients, balancing delivery quality, commercial objectives, and client expectations
Lead development and execution of global regulatory strategies across all stages of development, from pre‑IND to post‑marketing
Act as senior regulatory SME for complex and high‑impact programs
Serve as on‑demand Head / VP / Director of Regulatory Affairs for client organizations
Lead Health Authority interactions, including acting as Authorized Sponsor Representative when required
Provide strategic oversight and hands-on input into Health Authority meeting packages, special designation requests, and major regulatory submissions
Own financial and commercial management of the Service Line, including forecasting, budgeting, revenue planning, margin protection, and utilization

Fulltime

Director of Quality

Mantell Associates is partnered exclusively with a globally operating CDMO to re...

Location

United States , Massachusetts

Salary:

Not provided

Mantell Associates

Expiration Date

Until further notice

Requirements

Significant quality leadership experience within a CDMO, pharmaceutical or biotechnology manufacturing environment – CDMO experience strongly preferred
Proven experience leading site-level quality operations at scale, ideally within a large, complex GMP manufacturing facility
Hands-on experience across both biologics/mAb and small molecule modalities
Deep knowledge of FDA GMP regulations (21 CFR Parts 210/211/600) and relevant ICH guidelines
Demonstrated experience managing FDA inspections with a strong track record of successful outcomes
Proven QC oversight experience, with a solid understanding of analytical operations and laboratory compliance
Strong client-facing skills with the ability to build credibility and trust at a senior level
Exceptional leadership and people management skills, with experience developing large, diverse quality teams
Strategic thinker with the operational presence to engage credibly at all levels of a large manufacturing site
Bachelor’s degree or above in a relevant life sciences discipline

Job Responsibility

Own and drive the site QMS, ensuring all systems, processes and documentation are robust, inspection-ready and aligned with global quality standards
Lead site GMP compliance across biologics/mAb and small molecule manufacturing operations, ensuring adherence to FDA regulations and ICH guidelines
Oversee the site CAPA programme, deviation management and change control processes, ensuring issues are investigated thoroughly and resolved effectively
Drive a proactive, right-first-time quality culture across all site functions, from manufacturing and QC through to supply chain and engineering
Provide strategic and operational oversight of the site QC function, ensuring analytical testing, raw data review and results reporting meet the highest standards of accuracy and compliance
Partner with QC leadership to ensure laboratory operations are fully compliant, inspection-ready and continuously improving
Oversee out-of-specification (OOS) and out-of-trend (OOT) investigations, ensuring robust root cause analysis and appropriate corrective actions
Serve as the site quality authority for all regulatory matters, leading preparation for and management of FDA inspections and any other relevant agency interactions
Provide quality oversight and input into regulatory submissions, ensuring site-level documentation and data packages meet agency expectations
Monitor the evolving regulatory landscape and proactively update site quality systems and practices to maintain compliance

Vice president global head of statistics vcrd

Pfizer is seeking a Vice President, Global Head of Statistics to join our thrivi...

Location

United States , Pearl River; Collegeville

Salary:

274000.00 - 426800.00 USD / Year

Pfizer

Expiration Date

Until further notice

Requirements

Advanced degree in statistics, biostatistics, or related field required. PhD preferred.
15+ years of experience in drug development
5-10 years of experience in vaccine development
At least 5 years of managerial experience in drug development
Capability to provide statistical leadership to cross-functional teams and the ability to both communicate and influence the biostatical perspective to diverse audiences
Effective verbal and written communication skills relating to colleagues and associates both inside and outside the organization
A compelling and inspiring leadership style with a sharp scientific mind, who combines broad knowledge and understanding of biological systems and statistics. A world-class leader in his/her field.
Ability to perform sophisticated mathematical and statistical calculations, and to perform complex data analysis
Disaggregates complex problems to facilitate problem solving
Adept at distinguishing the relevance of information inputs to the decision-making process

Job Responsibility

Sets the vision and leadership for providing the highest level of data management, modeling, and statistical advice across the function to senior Vaccines Research and Development (VRD) leadership
Is accountable to lead the necessary stakeholders to plan, direct and coordinate a large and expanding portfolio of specialized and complex Vaccine Research and Development (VRD) projects spanning phase 1 through phase 4 clinical development
Must have the broadest knowledge of clinical data management and statistical analysis tools and interpret results from clinical, non-clinical, modelling and simulation, and epidemiologic studies
Is accountable to develop and roll out new initiatives and lead the VCRD Statistics group in strategic planning
Leads the activities of Senior Directors directing the statisticians and modelers in VCRD and at Functional Service Providers
Provides senior management review of protocols and CSRs, and is the senior representative to internal review committees, DMC-related company steering committees, etc.
Influences cross functional (TA) activities, in a consultative role, and provides the SVP of Clinical Research with more strategic advice as to the present and future direction for the VCRD Statistics group
Provides the highest level of strategic and statistic leadership to VRD leadership and the full vaccine portfolio
Lead and inspire the VRD statistics organization to provide the highest level of statistical and modeling support. Evaluates the material generated by supervised staff including senior director reports for validity, quality, and effectiveness of presentation and coaches them in preparation for regulatory and Key Opinion Leader interactions.
Provide senior management statistical review of key documents (protocols, CSRs, regulatory briefings)

What we offer

eligibility for participation in Pfizer’s Global Performance Plan with a bonus target of 30.0% 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 support available

Fulltime

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Senior Director – Global Regulatory Strategy Biologics

Job Description

Job Responsibility

Requirements

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