Director, Device Platform
3 settimane fa
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, and combination product technology platforms to meet pipeline needs. In addition, support existing commercial products and processes at internal and external manufacturing sites. They will work within cross-functional teams (with Quality, Supply Chain, Process Development, MTS, Regulatory, Clinical, and Commercial) to establish and manage project plans for clinical and commercial use. His/her team members will serve as representatives to support development activities on assigned CMC project team(s). Program activities will include evaluation of stakeholder needs, patient needs, evaluation and selection of vendors and manufacturers, and evaluation and management of costs.
Key Responsibilities Lead the establishment, development, and lifecycle management of primary container (syringe), device, and combination product programs to support Alnylam's portfolio of products.
Interact with clinical development partners (Clinical Ops, Regulatory, and Commercial) to provide expert development advice to assist the product teams.
Collaborate with expertise areas (Quality, Supply Chain, Process Development, MTS, Regulatory, Clinical, and Commercial) to establish project plans and timelines for clinical and commercial activities including resource loading and risk mitigations.
Review regulatory submissions for primary container, device, and combination product related scientific accuracy.
Contribute as a subject matter expert in the areas of Design Controls, Human Factors, and Risk Management.
Design, test, select, qualify, and scale up production of primary packaging, devices, and combination product systems focused on meeting/exceeding patient needs.
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.
Create and maintain documentation packages for platforms throughout their lifecycle, e.g., Design History Files.
Facilitate the process for evaluation of alternative actions to operationally deliver plan. Influence and drive development of solutions, criteria, and implications.
Drive timely decisions and facilitate active communication and information flow between team members, Program Teams, and impacted sites/expertise areas.
Schedule and run cross-functional team meetings to manage execution of project plans.
Prepare and present project status reports and metrics to Program Teams and Management.
Remain up to date with current regulations, industry guidelines, and practices to enable best practices across all activities.
Exceptional planning and organizing skills to plan and manage resources against timelines and commitments; must excel in a dynamic environment.
Alignment with Alnylam's core values: Commitment to People, Fiercely Innovative, Purposeful Urgency, Open Culture, and Passion for Excellence.
Qualifications Bachelor's degree, preferably in engineering or life sciences. Advanced degree preferred but not required.
Experience in the assessment, development and/or manufacture of drug products, primary containers, and devices required.
Experience in design controls and testing, human factors studies and/or risk management required.
Experience managing external vendors and contract manufacturers required.
Experience managing cross-functional teams required.
Must have excellent interpersonal and customer service skills.
Experience in building and leading a team required.
#J-18808-Ljbffr
-
Capital Medical Device Sales Director
6 mesi fa
Lazio, Italia Chronos Consulting A tempo pienoJob DescriptionCapital Medical Device Sales Director (Neuro)Location: MilanOur client is a leading provider of non-invasive surgical treatment in neuro, oncology/bone and urology. They are looking for a Sales Director Europe.This role has an overall responsibility regarding marketing & sales plans in the region and is accountable for sales revenues. In...
-
Sr Director
4 mesi fa
Lazio, Italia Invensense A tempo pienoFounded in 2003, InvenSense Inc., a TDK Group Company, is the world's leading provider of MEMS sensor platforms. InvenSense's vision of Sensing Everything targets the consumer electronics and industrial markets with integrated Motion and Sound solutions. Our solutions combine MEMS (micro electrical mechanical systems) sensors, such as accelerometers,...
-
Director, Regulatory Affairs, Cmc
1 settimana fa
Lazio, Italia Buscojobs A tempo pienoJob 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...
-
Director, Regulatory Affairs, Cmc
1 settimana fa
Lazio, Italia Buscojobs A tempo pienoJob 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...
-
Business Development Director
3 settimane fa
Lazio, Italia Clinchoice A tempo pienoBusiness Development Directorat ClinChoice (View all jobs)ItalyClinChoice 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...
-
Director, Regulatory Affairs, Cmc
1 settimana fa
Lazio, Italia Buscojobs A tempo pienoJob 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...
-
Group Account Director
3 giorni fa
Lazio, Italia Rgi Group A tempo pienoCompany Description Publicis Groupe: win in the platform world Publicis is part of Publicis Groupe, the world's third largest communications group. 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 their digital business...
-
Director, Regulatory Affairs, Cmc
4 mesi fa
Lazio, Italia Alnylam Pharmaceuticals Inc. A tempo pienoJob 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 objectives....
-
Group Account Director
1 settimana fa
Lazio, Italia Rgi Group A tempo pienoCompany DescriptionPublicis Groupe: win in the platform world! Publicis is part of Publicis Groupe, the world's third largest communications group. 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 their digital business...
-
Group Account Director
7 giorni fa
Lazio, Italia Rgi Group A tempo pienoCompany Description Publicis Groupe: win in the platform world! Publicis is part of Publicis Groupe, the world's third largest communications group.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 their digital business...
-
Midwifery Director
3 giorni fa
Lazio, Italia Qld Traffic A tempo pienoSouth West Hospital and Health Service is seeking a Midwifery Director to provide leadership and expert knowledge to support the services provided in the three hubs in conjunction with the Hub Directors of Nursing and Midwifery. Join us in building better health in the bush The Midwifery Director is responsible for operational and strategic leadership of...
-
Midwifery Director
5 giorni fa
Lazio, Italia Qld Traffic A tempo pienoSouth West Hospital and Health Service is seeking a Midwifery Director to provide leadership and expert knowledge to support the services provided in the three hubs in conjunction with the Hub Directors of Nursing and Midwifery.Join us in building better health in the bush!The Midwifery Director is responsible for operational and strategic leadership of...
-
Account Director
3 giorni fa
Lazio, Italia Adp - Automatic Data Processing A tempo pienoCompany Description Publicis Groupe: win in the platform world Bcube is part of Publicis Groupe, the world's third largest communications group. 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 their digital business...
-
Account Director
5 mesi fa
Lazio, Italia Bcube A tempo pienoCompany DescriptionPublicis Groupe: win in the platform world!Bcube 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...
-
Account Director
5 giorni fa
Lazio, Italia Adp - Automatic Data Processing A tempo pienoCompany DescriptionPublicis Groupe: win in the platform world!Bcube is part of Publicis Groupe, the world's third largest communications group.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 their digital business...
-
Business Development Director
2 settimane fa
Lazio, Italia Buscojobs A tempo pienoClinChoice 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 varied...
-
Business Development Director
3 settimane fa
Lazio, Italia Clinchoice Inc. A tempo pienoClinChoice 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 varied...
-
Business Development Director
1 settimana fa
Lazio, Italia Clinchoice Inc. A tempo pienoClin Choice 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 varied...
-
Business Development Director
3 settimane fa
Lazio, Italia Clinchoice Inc. A tempo pienoClinChoice 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 varied...
-
Midwifery Director
7 giorni fa
Lazio, Italia Qld Traffic A tempo pienoSouth West Hospital and Health Service is seeking a Midwifery Director to provide leadership and expert knowledge to support the services provided in the three hubs in conjunction with the Hub Directors of Nursing and Midwifery.Join us in building better health in the bush! The Midwifery Director is responsible for operational and strategic leadership of...
