Device Platform Director

17 ore fa


Italia Alnylam Pharmaceuticals Inc. A tempo pieno
Job Description

Alnylam Pharmaceuticals Inc. is seeking a highly skilled Director, Device Platform to lead the establishment, development, and lifecycle management of primary container, device, and combination product programs to support Alnylam's portfolio of products.


Key Responsibilities:

  • Lead Cross-Functional Teams: Collaborate with clinical development partners to provide expert development advice to assist product teams.
  • Establish Project Plans: Work with expertise areas to establish project plans and timelines for clinical and commercial activities, including resource loading and risk mitigations.
  • Review Regulatory Submissions: Review regulatory submissions for primary container, device, and combination product related scientific accuracy.
  • Design and Test: Design, test, select, qualify, and scale up production of primary packaging, devices, and combination product systems focused on meeting/exceeding patient needs.
  • Vendor Evaluation: Act as a technical representative for primary container, device, and combination product selection and evaluation of vendors, manufacturing and supply agreements, and qualification of vendors for supply and manufacture of components and finished products.
  • Documentation: Create and maintain documentation packages for platforms throughout their lifecycle, e.g., Design History Files.
  • Communication: Facilitate the process for evaluation of alternative actions to operationally deliver plans, and drive timely decisions and facilitate active communication and information flow between team members, Program Teams, and impacted sites/expertise areas.
  • Project Management: Schedule and run cross-functional team meetings to manage execution of project plans, and prepare and present project status reports and metrics to Program Teams and Management.
  • Regulatory Compliance: Remain up to date with current regulations, industry guidelines, and practices to enable best practices across all activities.
  • Leadership Skills: Exceptional planning and organizing skills to plan and manage resources against timelines and commitments, and must excel in a dynamic environment.

Qualifications:


  • Bachelor's degree, preferably in engineering or life sciences.
  • Experience in the assessment, development and/or manufacture of drug products, primary containers, and devices.
  • Experience in design controls and testing, human factors studies and/or risk management.
  • Experience managing external vendors and contract manufacturers.
  • Experience managing cross-functional teams.
  • Excellent interpersonal and customer service skills.
  • Experience in building and leading a team.



  • Italia Alnylam Pharmaceuticals Inc. A tempo pieno

    Job Description - Director, Device Platform (240127) Overview The Director, Device Platform Management manages a team of Scientists/Engineers to develop and execute implementation strategy for primary containers, devices, and combination products at Alnylam. Scope of work includes establishing and driving the implementation of device, primary container,...


  • Italia ClinChoice A tempo pieno

    Business Development Director at ClinChoice (View all jobs) Italy ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a Business Development Director to join our internal team in Italy. This role is a full...


  • Italia Alnylam Pharmaceuticals Inc. A tempo pieno

    Job Description - Director, Regulatory Affairs, CMC - Combination Products (220858) Overview The Director, RA CMC Combination Products will work cross-functionally to lead development and implementation of global combination product/Medical Devices regulatory strategies across all applicable programs and lifecycle stages in accordance with program...

  • Art Director

    3 giorni fa


    Italia Leo Burnett A tempo pieno

    Art Director - Extracurricular Internship Full-time Publicis Groupe: Win in the Platform World! Leo Burnett is part of Publicis Groupe , the world’s third largest communications group. What can we do as Publicis Groupe? Known for its world-renowned creativity , best in class technology , digital and consulting expertise , Publicis Groupe is the only...


  • Italia ClinChoice Inc. A tempo pieno

    ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a Business Development Director to join our internal team in Italy. This role is a full time permanent opportunity. You will work on projects from our...


  • Italia Alnylam Pharmaceuticals Inc. A tempo pieno

    Job Description - Director, Commercial Operations (240002) Overview The Director Commercial Operations is responsible for collaborating with multiple stakeholders across Alnylam’s U.S. commercial organization to enhance the productivity of U.S. field teams by generating insights from data, establishing KPIs, implementing more efficient processes, and...


  • Italia Teradata Group A tempo pieno

    Role SummaryThis is a customer-facing position that focuses on delivering operational excellence and acting as an assigned service management advisor for our customers. The successful candidate will be responsible for delivering a world-class support experience to our customers, accelerating the adoption of their Teradata products and services, and...

  • Sales Director

    2 giorni fa


    Italia Archipassport A tempo pieno

    Furniture Sales Manager OpportunityWe are seeking a skilled Furniture Sales Manager to join our team at Archiproducts Shop. As a key member of our commercial team, you will be responsible for developing and executing sales strategies, selecting supplier brands, and building a network of partners and sales channels.Key Responsibilities:Define, develop, and...


  • Italia ClinChoice Inc. A tempo pieno

    Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds.... ClinChoice is searching for an experienced Senior Project Manager/Director to work with one of our pharmaceutical partners to oversee Clinical...


  • Italia Dentsu International A tempo pieno

    Dentsu leads the region in digital media trading. We create more data, promote more audience engagement and track everything. We specialize in applications of technology that create unmatched return on investment for our clients. As a result, we take a view on the implementation of technology across our digital business. Our collaborative and agile ways of...


  • Italia Dentsu International A tempo pieno

    Dentsu leads the region in digital media trading. We create more data, promote more audience engagement and track everything. We specialize in applications of technology that create unmatched return on investment for our clients. As a result, we take a view on the implementation of technology across our digital business. Our collaborative and agile ways of...

  • Marketing Director

    2 settimane fa


    Italia Archipassport A tempo pieno

    About ArchipassportArchipassport is a global leader in architecture and design, connecting over 3.7 million followers with the industry's largest catalog and community of brands, architects, designers, and professionals.Our MissionWe continuously expand and innovate, providing cutting-edge digital solutions that drive growth and foster engagement. With a...


  • Italia ServiceNow A tempo pieno

    Employee Type: Fixed Term - Employee (Fixed Term) Region: EMEA - Europe, Middle East and Africa Work Persona: Flexible Company Description It all started in sunny San Diego, California in 2004 when a visionary engineer, Fred Luddy, saw the potential to transform how we work. Fast forward to today — ServiceNow stands as a global market leader,...


  • Italia 4050 DEVELOPMENT LLC A tempo pieno

    This role requires Casual Mobile Games sourcing and/or publishing experience Who are we? MAF is a cross-device mobile app marketing platform fueled by data and technology that helps brands acquire new users at scale. MAF's constantly growing mobile game publishing, Ciao Games is now looking for a new teammate to take over Business Development function...

  • Commercial Operations

    3 giorni fa


    Italia Eurofins Biolab S.r.l. A tempo pieno

    Commercial Operations & Inside Sales Manager - Team EU Medical Devices Full-time With more than 900 laboratories, approximately 62,000 employees, over 200,000 analytical methods, a widespread presence in 62 countries and an annual turnover of 6.7 BIL EUR, Eurofins is an international leading group in third party analytical services in the Pharmaceutical...


  • Italia Parcelhero A tempo pieno

    Job Description: We're looking for a talented Customer Experience Strategist to join our team at Parcelhero. As a key member of our organization, you'll be responsible for developing and implementing programs that improve both customer experience and efficiency through process improvements.Key Responsibilities:Customer Journey Optimization: Oversee the...

  • Creative Supervisor

    3 giorni fa


    Italia Leo Burnett A tempo pieno

    Publicis Groupe: win in the platform world! Leo Burnett is part of Publicis Groupe, the world’s third largest communications group. What can we do as Publicis Groupe? Known for its world-renowned creativity , best in class technology , digital and consulting expertise , Publicis Groupe is the only one in the industry able to best accompany its clients in...


  • Italia Planckian A tempo pieno

    At Planckian we develop architectures for quantum computers, scalable by design. Our approach leverages a unique platform to solve interdependencies at play between energy and quantum information processing, targeting operational efficiency. We are now seeking a Quantum Scientist to expand our team. If you: Are ready to join a group of emerging...

  • Sales Team Leader

    3 giorni fa


    Italia Doka GmbH A tempo pieno

    With more than 180 sales and logistics facilities in 58 countries, highly efficient in-house production and more than 9,000 employees, the Doka Group is one of the world’s leading companies for developing, manufacturing and distributing modern system formwork technology. Our strong and effective sales organization gives construction firms all over the...


  • Italia Nike A tempo pieno

    About the RoleWe're seeking a highly skilled Commercial Lead to join our Global Lifestyle Partnerships team. As a key member of our team, you will be responsible for managing complex commercial relationships with one of our most important strategic partners in EMEA.Key ResponsibilitiesDevelop seasonal assortments based on frameworks delivered by...