Clinical Supply Chain CDMO Project Manager

WHAT - Summary & Purpose Of The Position

As part of the Global Clinical Supply Management organization, the Clinical Supply Chain CDMO Project Manager is responsible for managing outsourced clinical packaging and distribution operations in compliance with Good Manufacturing Practices. The role supports the Clinical Supply Chain CDMO Management Lead in establishing and maintaining effective collaborations with external vendors to ensure the supply of materials required for the conduct of clinical studies.

The Clinical Supply Chain CDMO Project Manager executes responsibilities in accordance with current internal and external regulatory guidance and company processes, while meeting agreed timelines, resource constraints, and budget requirements. The role also contributes to continuous improvement activities and knowledge management related to the development of new chemical entities and the lifecycle management of products within development.

WHAT - Main Responsibilities & Technical Competencies

Clinical packaging and distribution responsibilities:

• According to the clinical forecasts / timelines, and in collaboration with CDMOs and Clinical Supply Chain Therapeutic Area groups, define the planning for packaging, labeling and distribution for studies outsourced and ensure the on-time supply to patients with no stock outs of IMPs
• Support in CDMOs selection and maintenance
• Assess the impact of changes in clinical studies on planning and propose mitigation plans accordingly
• Coordinate and lead meetings with CDMOs in charge of clinical packaging and distribution
• Monitor CDMOs performance through KPIs
• In collaboration with the Suppliers Quality Assurance department, set up and maintain of Quality Technical Agreements
• Ensure the on-time availability of the documents required for his/her activities, i.e. instructions, batch records, reports, specifications…
• In collaboration with the Operational Quality Assurance team, ensure the review of the batch records and instructions of clinical IMPs
• Manage quality events (deviations, change controls) in line with defined KPIs
• Ensure activities are performed as per the agreed budget and with respect to the procurement processes: request quotes, launch commitment requests and place purchase orders
• Ensure vendors are paid in due time and based on diligent invoices review
• Develop/maintain a network of efficient CDMOs / vendors to ensure his / her activities
• Implement and maintain robust collaboration with vendors to procure comedications and / or comparators
• Implement and maintain robust collaboration with vendors to supply materials required to support clinical packaging and distribution activities when performed internally (booklet labels, packaging materials, etc.)
• Monitor clinical kits destruction process under CDMOs responsibility when needed
• Present the results and progress of projects under his/her responsibility at internal technical meetings
• Ensure regulatory surveillance related to his / her activities (guidelines, GMP, Annex 13, Annex 1)
• Develop and optimize the team’s interfaces within GCSM as well as with the Operational Quality Assurance and Drug Product Management team
  
  

Continuous Improvement

• Support the Process and Compliance Project Manager while defining and / or adjusting GCSM processes / ways of working and providing effective as well as continuous feedback.
• Organize and actively participate in lessons learned exercises when needed.
• Contribute to continuous improvement projects within the Global Clinical Supply Management Department and/or wider Pharmaceutical Development.
• Be a promoter of continuous improvement processes and guarantee the method.
  
  

QEEHS Responsibilities

• Respect the Good Practices applicable (BPF, BPD, …), the rules of Energy Environment Health and Safety through the procedures applicable within the company.
  
  

CSR Responsibilities

• Apply and proactively contribute to actions for CSR development according to Ipsen guidelines.
  
  

HOW - Behavioural Competencies Required

Competency

Competency Behavioural Markers

Explanation of Choice

Excellence in execution

• Approaches priority setting and setting the stage through the lens of execution;
• Establishes clarity about the goals, accountabilities, timelines, and next steps; can identify or spot opportunities for real impact on patient and society;
• Able to be focused and performance driven with clear KPIs
• Plans and aligns effectively (steps, resources, timelines etc.);
• Displays a commitment to best practice sharing and setting
• Promotes single point of accountabilities.
  
  

Critical to ensure outsourced clinical packaging and distribution activities are planned, executed, and delivered on time, within scope, budget, and quality expectations.

Ensures Accountability

• Ensures single accountable referents per task, project, or outcome;
• Builds and anchors an environment where people ask for clarification when accountabilities are unclear;
• Consults and seeks relevant stakeholder views to enable decision making by consent;
• Takes personal accountability for decisions, actions, successes, and failures;
• Follows through on commitments and ensures others do the same;
  
  

Essential for governing outsourced partners, managing quality events, documentation, and ensuring commitments are met across multiple stakeholders.

Collaborates

• Collaborates and communicates without boundaries, continuously removing organizational barriers;
• Focuses on continuous improvement, integrating learnings and demonstrating resourcefulness and entrepreneurial mindset;
  
  

The role requires close collaboration with internal teams and external vendors to align plans, quality standards, timelines, and continuous improvement efforts.

Influences

• Listens and observes actively and builds on what others are saying;
• Gains insight into stakeholder objectives and identifies common interests;
• Actively seeks win win partnerships and solutions;
• Embarks internal and external stakeholders without hierarchical authority;
  
  

Influence without direct authority is required to align CDMOs and internal stakeholders on timelines, mitigation plans, and quality expectations.

Manage Complexity

• Identifies contradictory information to solve problems effectively;
• Develops and evaluates alternative scenarios and solutions;
• Identifies what truly matters and prioritizes decisions with real impact;
  
  

The role operates in a complex environment with changing clinical timelines, regulatory requirements, vendors, and quality constraints that must be actively managed.

HOW - Knowledge & Experience

Knowledge & Experience (essential):

• 5 years’ experience in an equivalent job within the pharmaceutical industry with significant international exposure with a bachelors degree, or 3 with a Master’s degree
• Experience managing complex investigational supplies for global clinical trials through an external network
• Experience in project management and facilitating communications in a highly matrixed environment
  
  

Knowledge & Experience (preferred)

• Experience in working with Clinical Packaging, Distribution and Sourcing CDMOs is strongly preferred.
• Experience in managing procurement of comparators/commercial medicines is preferred.
• Experience with RTSM platforms is a plus.
  
  

Education / Certifications (essential)

• Bachelor’s degree or global equivalent in relevant pharmacy, engineering, operations and supply chain management area required.
  
  

Education / Certifications (preferred)

• Advanced education including MBA, Masters, PhD or global equivalent is preferred.
• Certification in APICS, PMP, etc. is a plus.
  
  

Language(s) (essential)

• Fluent in English.
  
  

Ipsen Biopharmaceuticals, Inc. is an equal opportunity employer. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, national origin, age, gender, sexual orientation, sexual identity, marital status, military or veteran status, disability, genetic information, or any other category protected by applicable federal, state or local law.

Ipsen Biopharmaceuticals, Inc. conducts background screening, reference checks, and drug testing as part of its pre-employment screening process. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned.

All Employees are expected to adhere to all company policies and act as a role model for company values.

The annual base salary range for this position is $91,500-$134,200.

This job is eligible to participate in our short-term incentives program.

At Ipsen we are proud to offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts. Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more.

The pay range displayed above is the range of base pay compensation within which Ipsen expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills.