Sr. Director/Director Data Intelligence

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Hiring Remotely in Raleigh, NC
In-Office or Remote
Biotech • Pharmaceutical
The Role
Company Description

We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.  

PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and becoming one of the global leaders in its fields. We cover all therapy areas including medical devices.  

We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.  

Come and join us in this exciting journey to make a positive impact in patient’s lives.   

Job Description

The Sr. Director/Director, Data Intelligence (ADDI) will support pre-award study feasibility strategy through targeted data gathering and analysis.

ROLE AND RESPONSIBILITIES

  • Supports overall operational strategy globally, with a focus on our key therapeutic areas of Oncology and Rare Disease, so as to maximize Ergomed’s revenue and reputation by ensuring that relevant data from available data sources are researched, aggregated, and available to the Directors of Operational Strategy (DOSs) in the timelines required to prepare and deliver high quality, well-research proposals to Ergomed’s potential clients.
  • Assists with RFP, RFI, proposal review and response as directed by developing strategically targeted feasibility and related data packages including relevant graphics that support the Win Strategy for new business opportunities.
  • Analyzes trial protocols, study designs, and other project details to determine feasibility within the organization's capabilities and knowledge base and leverages those analyses when presenting feasibility data package.
  • Evaluates potential risks, challenges, and constraints associated with proposed projects, with a focus on any potential impact on feasibility activities and recruitment rate projections.
  • Researches and analyzes the current market trends, competitive landscape, and therapeutic area dynamics relevant to each proposed project.
  • Develops and maintains feasibility summaries including relevant graphics for specific indications as requested by the direct supervisor or the SVP, SSPC to minimize rework (e.g., landscape summaries for certain oncology indications as determined by the Director of Operational StrategyOncology, the Senior Director of Operational and Clinical Intelligence and/or the SVP, SPCC).
  • Documents which feasibility activities and search criteria have been used when transferring preaward feasibility data packages internally in case of absence to minimize rework or at project handover to post-award feasibility team.
  • Supports the development of processes and solutions to maximize pre-award feasibility package development and integration into the larger win strategy.
  • Tracks and provides information on potential data sources, including return on investment, to support executive investment decisions regarding acquisition of or access to future data sources.
  • Develops materials for bid defenses.  Attends bid defense preparation and bid defense meetings as requested.
  • Develops cases studies and reports as requested.
  • Supports SVP, Strategic Solutions and Patient Centricity and/or direct supervisor as needed on projects and activities.

 

Qualifications

Degree educated            in Life    Sciences              or equivalent 

  • Clinical research experience in Rare Disease and/or Oncology
  • Global feasibility experience
  • Experience managing  external partners
  • Previous experience in a CRO environment
  • Report writing and presentation skill
  •  Ability to handle multiple tasks to meet deadlines 

 

Ability to access, aggregate and distill data to create targeted data packages to support strategic goals.

Additional Information

Why PrimeVigilance  

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.   

To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.  

We offer:  

  • Training and career development opportunities internally   
  • Strong emphasis on personal and professional growth  
  • Friendly, supportive working environment  
  • Opportunity to work with colleagues based all over the world, with English as the company language  

Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join!   

  • Quality  
  • Integrity & Trust   
  • Drive & Passion   
  • Agility & Responsiveness   
  • Belonging  
  • Collaborative Partnerships   

Come and join us in this exciting journey to make a positive impact in patient’s lives. We look forward to welcoming your application.  

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The Company
HQ: Raleigh, NC
535 Employees
Year Founded: 1997

What We Do

Founded in 1997, Ergomed is a global provider of high-quality services to the biopharmaceutical industry, spanning all phases of clinical trials, post-approval pharmacovigilance, and medical information. Ergomed’s fast-growing services business includes an industry-leading suite of specialist pharmacovigilance (PV) solutions, integrated under the PrimeVigilance brand, and Ergomed Clinical Research, a complete, global Phase I-IV clinical development and trial management services with a strong heritage in the development of drugs in rare diseases and oncology.

• 1,400+ highly qualified professionals
• Global full-service CRO
• 25+ years of experience
• Therapeutic specialization in oncology
• Strong expertise in rare disease trials
• Robust clinical safety system
• Choice of leading drug safety databases

Our key services include:
• Clinical Research Services
• Pharmacovigilance
• Medical Information
• Regulatory
• Medical Writing
• Site Management
• Study Physician Support
• Biostatistics
• Patient Study Support

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