Design & Development Program Manager

Design & Development (D&D) Program Manager

Are you looking for an exciting new career opportunity? CellCarta, a renowned Contract Research Organization, is actively seeking a highly skilled and motivated D&D Program Manager to join our dynamic team. As a D&D Program Manager, you will have the opportunity to use your expertise and skills to ensure that our services meet the highest industry standards. Come work with a team of talented individuals who are committed to making a positive impact on human health and well-being. Apply today!

Summary

As a D&D Program Manager, you will lead and oversee projects, collaborating with both internal teams and external clients (primarily pharmaceutical and biotech partners in oncology), to ensure timely and complete delivery in accordance with the CellCarta Quality System.

You will gain a comprehensive understanding of the entire business model and will often be the first to identify our customers' needs. As a CellCarta D&D Program Manager, you will be responsible for upholding the 3T principles: keeping the project on Task, on Track, and on Time.

You will need to be comfortable with the following:

• Actively listening to customers and building relationships to ensure client satisfaction;
• Managing pressure effectively;
• Prioritizing effectiveness over being right;
• If you're organized, analytically driven, have a strong technical background, and can thrive in a dynamic, high-complexity environment, this could be the perfect role for you
  
  

Responsibilities

The D&D Program Manager is responsible for delivering clinical assays used in patient management decisions, ensuring the project stays within the agreed upon scope, timeline, and budget. This is achieved by coordinating various tasks performed by both internal and external partners. The D&D Program Manager ensures that the project adheres to CellCarta's ISO13485 quality system. His/Her responsibility begins before a clinical assay development is assigned to CellCarta and extends through the clinical validation of the assay.

More specifically, you will participate in the following:

• Lead a cross-functional team by actively engaging and aligning stakeholders to ensure successful assay development, deployment, and submissions that meet customer objectives;
• Take responsibility for managing high-profile assay D&D projects, carefully overseeing timelines and resources to ensure on-time delivery. Develop and communicate a long-term vision, while regularly conducting risk assessments to identify and address potential challenges. Proactively manage the assay, anticipate risks, and communicate them to the customer, offering alternative solutions when obstacles arise;
• Enhance efficiency and productivity by refining operational frameworks and optimizing processes. Conduct thorough evaluations to eliminate waste and continuously seek opportunities for improvement and innovation;
• Ensure all essential documents for internal and external submissions are prepared and managed to achieve timely assay readiness;
• Oversee study budget control;
• Maintain clear and professional communication with the sponsor, cross-functional project teams, and management throughout the study;
• Lead sponsor calls and meetings
  
  

Education

• A Master's degree in Sciences, Biomedical Sciences, Pharmaceutical Sciences, Medical Biology, Medicine, or equivalent expertise gained through experience
  
  

Main Requirements

• 6+ years of project management, and/or CRA (Clinical Research Associate) experience, or a background in genomics or histopathology laboratories;
• A strong curiosity and eagerness to learn, coupled with a humble and teachable attitude;
• Proven track record of successfully managing (complex) projects to completion with excellent feedback, and the ability to prioritize multiple opportunities effectively;
• Exceptional communication skills, fluent in English, with the ability to write clearly and present ideas persuasively;
• Proficient in Microsoft Office (Word, Excel, PowerPoint, PowerBI);
• Excellent organizational skills with the ability to multitask;
• Positive, energetic, and proactive attitude;
• Able to take initiative, adapt, and thrive in a dynamic environment;
• Detail-oriented with strong diligence;
• Capable of working both independently and as part of a team;
• Strong critical thinking and problem-solving skills;
• Customer and project management service-oriented;
• A solution-focused mindset with a persistent, can-do attitude
  
  

It's a plus, though not required, if you have:

• Experience with ISO13485;
• Background in cancer research, with an understanding of clinical laboratory operations, assay/instrument principles related to in vitro diagnostic product design and usage, and the scientific, statistical, regulatory, and compliance requirements of clinical research;
• Experience working in CAP, CLIA, and GCP environments, with a solid understanding of EMA and/or FDA guidelines for clinical trials;
• Experience working in global settings
  
  

Working Conditions

• This is a remote position, and there is no requirement for onsite presence
  
  

Benefits

We offer a wide range of benefits including:

• Competitive Wages ($115,000 - $145,000 USD);
• Medical, dental, and vision benefits;
• 401k retirement savings plan with a healthy match;
• Vacation and sick time;
• Employee Assistance Program (EAP);
• Career development opportunities
  
  

About CellCarta

CellCartais a leading provider of specialized precision medicine laboratory services to the biopharmaceutical industry. Leveraging its integrated analytical platforms in immunology, histopathology, proteomics, and genomics, as well as related specimen collection and logistics services, CellCarta supports the entire drug development cycle, from discovery to late-stage clinical trials. The Company operates globally with facilities located in Canada, USA, Belgium, Australia, and China.

Joining CellCarta means working with dedicated professionals who are focused on achieving our mission of impacting the future of patient therapy. We make a difference in the lives of patients around the world!

Join us as we make an impact on patient therapy!

The information collected to review your application will be processed by the human resources services of CellCarta Biosciences Inc. and its affiliates (collectively, “CellCarta”). The legal basis for this processing is the legitimate interest of CellCarta to evaluate the suitability of candidates for the roles available at CellCarta.

CellCarta will only process that information which is necessary to evaluate your application. This information includes identifying information such as your name, address, email address and phone number, as well as information about your education and professional experience, including previous positions and your CV. Such information is required for us to complete your applicant file, assess your suitability for the role and comply with applicable laws. CellCarta may obtain personal information from other sources, such as during reference, background, or employment checks, with your permission, and from third party sources such as recruitment and assessment sites or professional social media sites, in each case only if such information is relevant to reviewing your application. Your personal information will be retained only for so long as reasonably necessary and in accordance with applicable laws. This information will be processed confidentially and only accessed by those who have a need for the recruitment process. Please note that the information comprising your applicant file may be processed in a country that is not where you are located (for example, you might be in the European Economic Area or Québec, Canada, whereas your applicant file may be reviewed by CellCarta in the United States). If you are offered and accept employment with CellCarta Biosciences Inc. or one of its affiliates, the information collected will become part of your employment record. If you do not want us to retain your information, or want us to update it, please contact [email protected].

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