Medical Device & Combination Product Development Project Manager

Job content

About Idorsia Pharmaceuticals Ltd

Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients.

In order to achieve this, we will develop Idorsia into one of Europe’s leading biopharmaceutical companies, with a strong scientific core.

Headquartered in the Basel Area (Allschwil) in Switzerland - a European biotech hub - Idorsia is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet – the ideal constellation to bringing R&D efforts to business success.

Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 800 highly qualified specialists dedicated to realizing our ambitious targets.

Job Responsibilities

• Accountable and responsible for end to end project management from concept to market launch to meet business objectives
• Provide sound project strategy, organization, budget, and planning management cross-functionally and with partners/suppliers
• Accountable for timely execution of the allocated projects including alignment of cross functional deliverables (technical, quality, regulatory, operations, supply)
• Provide operational strategy and investment plan
• Provide technical, engineering, human factors, and operations expertise for medical devices & combination product for clinical phases and commercial launch
• Efficiently collaborate with all involved functions beyond core team (e.g. LCT, Marketing)
• Improve project management phase gate process, align with all stakeholders and deploy/train the organization accordingly
• Ensure compliance with all local, state, federal, and Idorsia quality policies, procedures and practices, safety regulations, policies, and procedures
• Elaborate overall projects strategy, phase gates to project plan and detail planning across functions
• Report project progress by means of key indicator implementation
• Lead joint core team meetings
• Por actively address/lead issue resolution with core team and effective solution implementation in collaboration with suppliers, service providers and internal network
• Lead supplier/partner relationship and leverage all possible partner/supplier knowledge and documentation to maximize efficiency while ensuring their regulatory readiness
• Elaborate operation strategy for clinical phase and product launch / continuity of supply in accordance to forecasts
  

Candidate Requirements

• Undergraduate degree in related engineering field, advanced degree desired
• Minimum 10 years of experience in combination product project management, with 7 years demonstrated combination product project management in pharmaceutical industry
• Track record of successfully delivering combination products to market
• Proven track record of successfully leading combination product projects from planning to execution, preferably in the field of parenteral delivery systems (e.g. prefilled auto-injectors, pens, patch pump)
• Excellent project management skills and sound knowledge of cross-functional requirements (technical, human factor, quality, regulatory and operations/qualification-validation)
• Broad and deep understanding of disciplined product development processes, regulatory and quality requirements as well as GMP & ISO 13485
• Strong persuading, influencing and negotiation skills
• Capability to successfully engage, collaborate and influence with different stakeholders at all levels of seniority
• Demonstrate agility and action orientation when facing change and uncertainty
• Excellent and communication skills in English (oral and written)
  

What Idorsia Offers

• Exciting opportunities for development and professional growth within our dynamic organization
• A collaborative and solution-oriented environment where you can make a difference
• An innovative and open culture in a truly multicultural environment
• A competitive salary and generous social benefits
  

Work Location:Allschwil

Country:Switzerland

Business Area: Global Pharmaceutical Development & QA

Schedule: Fulltime

Job Type: Permanent

Job ID: 2664

If you are interested, please click on apply now.

Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you will be informed in greater detail in due course.

Idorsia operates a strictly controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia, please note that all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.