Manager, Early Development Regulatory Lead Job at Alfasigma (Bologna)

Global Trial Manager - Early Development

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

Location

United States , CARY, BLUE BELL, RAHWAY, NJ

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

BA/BS/BSc or RN
At least 4+ years experience overseeing clinical trials including the oversight of Functional Service Providers, and outside vendors (CROs, central labs, imaging vendors, etc.)
Experience overseeing early phase studies (phase I) for biotech, pharmaceutical or CRO
Strong clinical project management skills and experience in driving milestones
Excellent communication and interpersonal skills to effectively work with cross-functional teams
Proficient in trial management systems and MS Project (or equivalent PM software)
Knowledge of ICH/GCP and regulatory guidelines/directives

Job Responsibility

Leads the study level planning and execution of overall operational deliverables, including study level forecast of investigational products and study logistics plan
Develops the strategic scenarios of designs for early phase clinical development plan
Ensures standard processes, tools, and procedures are used consistently
Routine engagement with Clinical Investigators
Provide oversight, support the design, and manage operational activities related to the planning, implementation, and reporting of outsourced Clinical Pharmacology studies
Leads, manages, and monitors overall study related activities including: Issues related to patient eligibility, enrollment and protocol deviations
Ongoing safety data review and completion of study data collection, data lock, and analysis
Resolution of cross-functional study-specific issues
Communication of study status to key stakeholder and updating relevant systems
Ensures study personnel are appropriately trained and understand study timelines and deliverables

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

Global Development Product Lead

Leads multiple cross functional oncology product teams from pre-clinical candida...

Location

United States , La Jolla; Cambridge; Bothell; South San Francisco; New York City

Salary:

295900.00 - 478800.00 USD / Year

Pfizer

Expiration Date

Until further notice

Requirements

MD or MD-PhD with 10+ years of industry experience in oncology drug development is preferred, track record in oncology clinical research including early phase drug development
Clinical oncology experience: Board certification in oncology preferred
Significant industry leadership experience in clinical, translational or basic research in biomedical sciences or one of the disciplines related to drug development
Understanding of related disciplines (e.g., biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences)
Demonstrated scientific productivity (publications, abstracts, etc.)
Proven scientific writing skills and good communication skills
Proven leadership skills with ability to defend the clinical plan at governance meetings is essential
Capacity to adapt to a fast-paced and changing environment
Demonstrated history of effective leadership
including cross functional and matrixed teams, managing direct reports when applicable, and experience in seeking and maintaining alignment with cross-functional leaders

Job Responsibility

Leads multiple (~2-4) cross functional oncology product teams from pre-clinical candidate nomination (CAN) through Phase 1-2 clinical development and proof of concept (POC) stages
In close collaboration with functional experts on the product teams, drives the effective integration of an end-to-end cross functional molecule strategy and risk mitigation plan and ensures delivery of data-driven milestones through successful risk identification and mitigation
Support clinical trials and the development strategy for early development assets and lead development programs across multiple functions within Pfizer Oncology, as well as represent the program with the external clinical community
Develop clinical development plan from first in human clinical trial to proof-of-concept, including assessment of appropriate combinations, as well as evaluation of potential predictive and pharmacodynamics biomarker plans
To ensure the cross-functional components of the product plans including clinical expertise are provided to project teams, including medical monitoring of clinical trials
Substantial support of CDP development and diligence for external innovation activities
Lead key enterprise level cross-functional workstreams to accelerate R&D decision making
Lead, develop and execute strategic development for early development assets
Ensure timely execution and delivery of product milestones within budget
Communicate with executive management and governance committees to address program needs and provide recommendations

What we offer

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 assistance may be available based on business needs and/or eligibility

Fulltime

Senior Project Manager - Engineering

Lead the successful completion of the project lifecycle of new products from con...

Location

United States , Easton

Salary:

Not provided

Victaulic

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree in engineering, business, or related technical discipline preferred and/or 8+ years extensive experience in project management
Proven experience as a Project Manager in New Product Development, with a track record of successfully launching products to market
Project Management Certification or degree (e.g., PMP or equivalent) strongly preferred
Demonstrated leadership skills, with the ability to inspire and guide cross-functional teams
Ability to adapt and thrive in a fast-paced, dynamic environment, managing multiple projects simultaneously
Strong strategic thinking and problem-solving abilities, with a focus on achieving business objectives
Analytical mindset and keen attention to detail
Excellent communication, negotiation, and interpersonal skills to engage with stakeholders at all levels of the organization
Strong negotiation and conflict resolution skills, with the ability to facilitate productive discussions and reach consensus
Mechanical aptitude and knowledge of manufacturing environment

Job Responsibility

Project Management: Assume full ownership and accountability for multiple new product development initiatives, setting clear objectives and direction for cross-functional teams
Responsible to develop and maintain project schedules, adhere to policies, procedures, and standard work processes
Assist Product Management to complete project charters outlining scope, goals, deliverables, required resources, budget, and timing per the roles and responsibility guidelines in VPG-001
Leadership: Mentor and help develop project management staff, promoting professional growth and excellence in project execution
Motivate and guide cross-functional teams effectively
Participate in building and training project teams to expand their capabilities by establishing best practices, policies, PM methodologies, quality assurance and control, tools, and templates
Strategic Planning: Develop comprehensive project plans aligned with organizational goals, ensuring timely and efficient execution of projects
Team Management: Lead, inspire, and mentor project teams, fostering collaboration, creative thinking, and a high-performance culture to achieve project milestones and objectives
Stakeholder Management: Engage with internal and external stakeholders, to include executive leadership, to gather requirements, manage expectations, and ensure seamless communication throughout the project lifecycle
Demonstrated competency in creating presentations and ability to confidently present and interact with all levels of the organization

Fulltime

Executive Director, Medicine Development Leader

GSK is seeking a highly skilled Executive Director, Medicine Development Leader ...

Location

United States; United Kingdom , Waltham; London; Stevenage; Collegeville

Salary:

242250.00 - 403750.00 USD / Year

GSK

Expiration Date

Until further notice

Requirements

Advanced degree including MD, PhD, PharmD, MBA, MS
Drug development expertise in the global pharmaceutical/biotechnology industry
Filing experience with BLA/NDA/MAA submissions as a core responsibility
Experience in the entirety of drug development across the R&D/commercial life cycle including Discovery, late-stage Development, Regulatory, Manufacturing Medical and Commercial
Experience in product development and/or commercialization, in late phase development (from clinical PoC onwards), clinical trial management, post-approval studies, regulatory and manufacturing compliance
Experience leading teams in a complex, matrixed, global and multi-disciplinary organization with high accountability, minimal authority and multiple lines of reporting
Experience working with regulators and with regulatory requirements including legal and government frameworks within and across global geographies
Experience creating the strategy for pre- and post-marketing studies and driving the lifecycle process
Experience building budgets and leading the strategic and budget planning process
Experience the healthcare environment, and access in all major markets

Job Responsibility

Act as a single point of accountability in GSK for all aspects of a medicine being developed globally, from proof of clinical activity (POC) to Approval in all major market(s)
Work closely with the Early Development Lead (EDL) and Medicine Commercial Lead (MCL) to ensure a smooth transition of the lead indication(s) from the EDL upon achievement of clinical PoC and to the MCL upon Approval in first major market(s)
Post-approval, provide key support to the Medicine Commercial Team (MCT) in the first major markets ensuring the MDT provides optimal support to registration, including Post-Marketing Requirements (PMRs) and life cycle management (LCM) in the major markets
Work with the functional line Heads supporting RIIRU to select MDT members and lead this multi-disciplinary matrix team, supporting differentiated development for team members, owning the performance of the MDT and partnering with Line Managers to drive performance
Partner with the Pipeline Project Manager (PPM), energize and motivate the MDT to drive a high performing team and operational delivery of the project, including setting team objectives to ensure successful project delivery, including options for acceleration, parallel indication development and smart risk-taking.
Partner with R&D Business Development, leading the development planning for a prospective in-licensed asset by bringing together input from the relevant functions and TA experts to develop a Medicine Profile (MP) and development plans including but not limited to clinical feasibility, regulatory planning and CMC risk mitigation
Leads the cross-functional MDT to: Establish a compelling vision for the medicine and Target Medicine Profile (TMP) which positions the medicine within the R&D strategy taking the competitive landscape into account, translating GSK’s strategy into asset strategy and actionable plans for multiple areas or functions
Deliver differentiated medicines of value for patients, stakeholders and markets through an evidence package that supports regulatory approval, market access and the product’s life cycle
Prioritize and maximize the asset’s development options including developing multiple indications
Partner with the Global Medical Lead (GML) and MCL to develop an indication expansion and LCM plan for the asset.

What we offer

Annual bonus
Eligibility to participate in our share based long term incentive program
Health care and other insurance benefits (for employee and family)
Retirement benefits
Paid holidays
Vacation
Paid caregiver/parental and medical leave

Fulltime

Collections Manager

This is your opportunity to shape the future of collections at Brighte, turn the...

Location

Australia , Sydney

Salary:

Not provided

Brighte Capital

Expiration Date

Until further notice

Requirements

Regulatory expertise with working knowledge of NCCP, ASIC, BCOP, AFCA and other relevant regulatory standards for debt collection, loss recovery and hardship handling
Leadership experience in leading a small to mid-sized team, with a blend of onshore and offshore staff
Experience working through structural uplift and capability building without large support ecosystems
Governance-mindset and competent in establishing governance rhythms, DA frameworks, and risk controls
Experience in designing training programs and competency models for debt collection, loss recovery and hardship handling
Practical understanding of collections tools and technology - including collections tools, skip tracing, workflow automation and QA data requirements
Track record of successfully uplifting or rebuilding collections functions without destabilising team culture

Job Responsibility

Design and implement a scalable collections operating model with auditable processes
Establish and maintain policies, controls, decisioning frameworks, QA protocols, and reporting aligned with regulatory standards
Convert informal communication channels into structured workflows
Partner with Product and Engineering to leverage technology for workflow allocation, segmentation, QA reporting, and automation
Develop tailored customer contact strategies for early, mid, and late-stage arrears
Integrate skip tracing and optimise resource allocation through segmentation
Monitor performance metrics and loss trends to drive continuous improvement
Design and deliver training programs, competency models, and coaching frameworks for collections and hardship handling
Lead and inspire a small but mighty team based onshore and offshore, balancing hands-on involvement with strategic oversight, while fostering a culture of accountability, transparency, and growth
Act as a trusted partner to Risk & Compliance, Finance, and other internal stakeholders

What we offer

Flexible working arrangements to suit individual needs and a hybrid work model
Free lunch on Mondays
Range of social activities including weekly Thursday social event
Opportunity to join Employee Share Option Plans (ESOP)
Stocked pantry with snacks
Carefully curated collection of wines and beer on tap
End-of-trip facilities with towel service and hair dryers
Anniversary leave

Fulltime

Lung cancer MAS team lead

Acts as a line manager leading a team of MAS. Shapes the local strategy and ensu...

Location

Japan , Tokyo

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

Minimum requirement: 4-year university undergraduate degree AND master’s degree in life science, or Pharmacists >4-year university graduates with pharmacist license and master’s degree or equivalent life science research experience, or >6–year university graduates with pharmacist license, or Nurses with a master’s degree, or Veterinarians, or Dentists, or MDs
Preferred: MD (clinical experience, board certification preferred), or PhD in Life Science
Experience in the pharmaceutical industry, preferably as a Medical/Scientific Advisor, MSL, team lead, and/or clinical experience with direct patient care and/or professional experience in the pharmaceutical industry in relevant areas
MA/DJ experience and / or research experience preferred
Scientific publication
Strategic Thinking: Ability to consider the direction of Medical from a mid-to-long-term perspective and formulate strategies as a manager at Pfizer
Communication Skills: Ability to conduct clear and efficient communication, including with other departments, and convey information accurately and logically
Decision-Making Ability: Ability and responsibility to make quick and effective decisions even in situations where there is no clear answer
Leadership: Ability to influence teams and departments and drive them towards achieving organizational goals
Financial Skills: Ability to manage budgets and execute actions reliably and on schedule

Job Responsibility

Acts as a line manager leading a team of MAS
Shapes the local strategy and ensures the delivery of scientific-medical expertise and exchange with KOLs in the assigned therapeutic area
Lead the Pfizer Japan medical scientific point of contact for HCPs, medical societies, regulators, academia and other external stakeholders
Play a central role as a scientific and medical leader who can identify unmet medical needs(UMRs), drive the building and executing medical plans and oversee establishment of clinical evidence
Demonstrate medical and scientific leadership and expertise
Ensure and oversee the highest scientific standards during in / external activities to provide deep medical and scientific expertise
Lead development of local medical plan aligned with global medical plan to address local UMRs and fill data gaps, and manage implementation of local medical strategies and life cycle clinical plans for inline and pipeline medicines / vaccines
Direct and supervise providing and exchanging medical/scientific information for/from medical facilities in the assigned area and external stakeholders and make strategic decisions on medical strategies for assigned products
Drive and monitor heightened understanding of the burden of disease in the assigned therapeutic area and medical attributes of our products to enhance the safe and efficacious use
Lead achievement of department/team goals, and/or manage cross-organizational projects, providing guidance and accountability for results

Fulltime

Regulatory Affairs Consultant

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

United States , Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

4–6 years of CMC regulatory experience in the pharmaceutical industry for a Consultant level role, 7+ years for a Senior Consultant
Proven success in preparing regulatory documentation for FDA, EMA, and Health Canada (IND, NDA, DMF)
In-depth understanding of drug development, manufacturing processes, GMP, and regulatory frameworks for small molecules and biologics
Strategic and proactive mindset with strong operational execution
Excellent analytical, problem-solving, and negotiation skills
Effective communicator with strong interpersonal, presentation, and leadership abilities
Ability to manage multiple projects independently in a matrixed, multicultural environment
Proficiency in Microsoft Office Suite and regulatory systems
Bachelor’s degree in Pharmaceutical Sciences, Chemistry, or related field
Advanced degrees (Pharm.D., M.S., Ph.D.) in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology, or Biology preferred

Job Responsibility

Provide regulatory strategy input for small molecule and biologic products
Support regulatory leads in developing contingency plans for CMC-related scenarios
Represent CMC Regulatory Affairs in cross-functional project meetings and provide regulatory guidance in collaboration with global regulatory leads
Prepare, coordinate, and review CMC and GMP-related documents for regulatory submissions
Develop CMC strategies for products across all phases—from early development to marketing applications and post-approval changes
Partner with manufacturing, quality, and external organizations to address CMC-related issues
Maintain collaborative relationships with internal stakeholders, affiliates, contract manufacturers, packagers, and suppliers
Support planning and execution of Health Authority meetings, including mock sessions
Identify and implement process improvements to enhance regulatory efficiency and readiness
Participate in monthly CMC Global Regulatory Team meetings to align strategies across functions

What we offer

Flexible work arrangements
Opportunities for career growth
Supportive and inclusive environment
Diverse and global client exposure
Learn from experts

Fulltime

Treasury & Trade Solutions & Corporate, Commercial and Public Sector Sales Head

The Treasury & Trade Solutions & Corporate, Commercial and Public Sector Sales H...

Location

Jordan

Salary:

Not provided

Citi

Expiration Date

Until further notice

Requirements

Prior work experience in Citi or other financial services experience in the areas described above
Relevant experience in the field of transaction banking or relationship management
Experience & Ability to work with broad group of stakeholders including Relationship / Coverage, Product, Operations, Legal, Compliance, Offshore Citi colleagues etc.
Ability to quickly understand cash and trade product propositions, business drivers, policies, customer needs and market and competition
Demonstrate thought leadership
Ability to create longer term, content, trust and advisory based relationships with customers and partners
Managing effectively, the success transfers from TTS regional and global cash and trade sales teams
Bachelor or Masters (preferred) Degree in Business, Finance, Economics, Accounting, Engineering, and Maths etc. (other areas of specialization will be considered on a case-by-case basis)
English and Arabic proficiency is mandatory.

Job Responsibility

Clearly articulate & drive the TTS/CCPS narrative & agenda with franchise stakeholders & clients
Development of the local TTS franchise in direct alignment with TTS’ global strategic priorities, market trends, regulations, and customer needs
Drive sales performance locally across TTS Sales & Coverage teams and step in as an escalation point if required to deliver optimal solutions to clients
Ensure pipeline management discipline & execution against defined Sales KPI’s
Support RFP & implementation activities where required & oversee timely revenue ramp up of new business
Provide local competitive analysis, market intelligence/expertise & network sensitivity to identify emerging opportunities or threat
Embed customer segmentation, product positioning, pricing, and marketing plans for each client segment through strategic framework lens
Oversee TTS training & ongoing TTS updates across local Coverage & Franchise partners
Act as the local senior contact for TTS opportunities
Lead TTS client experience agenda across the country ensuring visibility & engagement on all key client issues & escalations

Fulltime

Manager, Early Development Regulatory Lead

Alfasigma

Location:
Italy , Bologna

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
March 04, 2026

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Job Description:

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