Director, Clinical Business Development

Full-time
Allows Remote

Overview:

The Business Development (BD) executive will focus on customer acquisition by locating, developing, defining, negotiating, and closing business in late-phase clinical trial services. As lead generation and prospect management are the main concern, the business development executive will target, identify, and qualify new business opportunities with current and potential clients. The BD executive must be well-spoken, energetic, and possess an eagerness to close new business and increase the company’s revenue streams. Invicro is a unique, global clinical imaging and software research company that was founded with a mission of improving the role and function of imaging in translational drug discovery and development.  To this effort we offer a suite of services and software with applications ranging from tissue to human, from target identification to Phase IV trials, across the entire spectrum of imaging techniques. This position requires interfacing with the scientific leaders of Invicro, as well as communicating effectively with Invicro’s current and future clientele. The quality of these communications impacts the growth of Invicro and its global reputation.

Responsibilities:

  • Identifies, qualifies, and secures new business opportunities.
  • Builds business relationships with current and potential clients.
  • Collaborates with sales and leadership from various in-house business units to maximize product offering and to secure, retain, and grow accounts.
  • Develops negotiating strategies and positions by studying integration of new venture with company strategies and operations; examining risks and potentials; estimating partners’ needs and goals.
  • Identifies trendsetter ideas by researching industry and related events, publications and announcements.
  • Screens potential business deals by analyzing market strategies, deal requirements, potential, and financials; evaluating options; resolving internal priorities.
  • Closes new business deals by coordinating proposal development and delivery; developing and negotiating contracts; integrating contract requirements with business operations.
  • Updates job knowledge by participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.
  • Creates informative presentations; presenting and delivering information to potential clients at client meetings, industry exhibits, trade shows, and conferences.
  • Develops customized targeted sales strategies.
  • Maintains database (iCRO, HubSpot, Salesforce, or equivalent) of existing and prospective client information and communications.

Ability to travel overnight 25-50% for customer contact; medical conferences, trade shows, etc.

Must have the ability for occasional travel to the various Invicro offices, nationally and internationally, as required.

Qualifications & Skills:

  • Bachelor’s degree and proficient sales experience in a relevant field.
  • Scientific background and training.
  • Be socially adept and good with numbers.
  • Knowledge of the sales process from initiation to close.
  • Ability to work independently or as an active member of a team.
  • Experience with lead generation and prospect management.
  • Excellent verbal and written communication skills; the ability to call, connect, and interact with potential customers.
  • Be persuasive and goal-oriented; self-motivated and self-directed.
  • Ability to multitask, triage obligations, reprioritize on the fly, if necessary, and manage time efficiently.
  • Ability to gain a full-bodied and in-depth understanding of company services and its position within the industry.
  • Excellent written and verbal communication skills; able to demonstrate patience and enthusiasm while communicating with potential clients.
  • Ability to professionally and confidently communicate with C-Level Executives.
  • Ability to work accurately under stress and pressure to meet competing deadlines.
  • Proficiency in MS Office (Outlook, Word, Excel, PowerPoint) and the ability to gain proficiency on iCRO.
  • At least 5+ years of B2B sales experience, preferably in clinical research services market.
  • MBA Preferred

Invicro is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity.

Molecular Imaging

About MPI Research: MPI Research, with global headquarters in Mattawan, Michigan, provides discovery, safety evaluation, bioanalytical, and analytical services to the biopharmaceutical, medical device, animal health, and chemical industries. Scientific knowledge and experience, integrity, trust, teamwork, and dedication to strong and enduring Sponsor relationships are the defining attributes that characterize MPI Research as a high-performance, high-quality organization that is committed to bringing safer and more effective products to the world. Learn more about how we can exceed your expectations at www.mpiresearch.com.

Responsibilities:

A Senior Scientist supporting the Translational Imaging Center (TIC), which is aligned with the Drug Metabolism Pharmacokinetics (DMPK) Division of MPI Research, is responsible for developing and/or validating methods and/or procedures to support required radiopharmaceuticals/radiotracers, to either quantify/synthesize chemical entities, or prepare formulated test articles or supporting compounds, or conduct studies of chemical compounds in vitro or in vivo, according to applicable Standard Operating Procedures (SOPs), study protocols and/or GxP regulations. The individual in this role serves as a key point of contact with Sponsors, colleagues, and represents MPI Research through active engagement within the scientific community, including regular meeting attendance and publications/presentations. A Senior Scientist is expected to work independently, may supervise others, and may function as a Principal Investigator, Contributing Scientist, and/ or Study Director.

(Duties & Responsibilities – purpose of the function and result to be accomplished) include but are not limited to those listed:

  • May be responsible for supervisory functions in accordance with the organization’s policies and applicable laws to include interviewing, hiring, training, and developing employees; planning, assigning and directing work; appraising performance and completing annual performance review on or before due date; rewarding and disciplining employees; addressing complaints and resolving problems.
  • Leads efforts to establish methods to produce novel chemical entities/radiopharmaceuticals/radiotracers, and/or leads method development/technology transfer to produce established entities and supporting compounds.
  • Leads others in the completion of method validation studies and/or formulation procedures.
  • Maintains applicable laboratory equipment and operations according to industry standards and regulatory guidelines as applicable.
  • Leads problem-solving efforts for technical and/or regulatory issues.
  • Documents procedures and materials in compliance with GxP standards, as applicable.
  • Operates laboratory instruments, including their respective software applications; may function as Subject Matter Expert (SME) and/or Application Owner (AO).
  • Assists in the completion of laboratory investigations and quality observations, as needed.
  • Recognizes method and/or data issues, and communicates them to management and/or Sponsors to minimize study impact.
  • Implements new technology and or platforms, leading the selection and developing case arguments for investment.
  • Promotes industry best practices.
  • May oversee sample analysis and validation studies as a Principle Investigator, Study Director, or Contributing Scientist, as assigned.

Qualifications:

  • Bachelor’s/Master’s degree in a relevant field and 10-15 years of relevant experience; or
  • Doctoral degree in a relevant field and 5-10 years of relevant experience.
  • Proficient using laboratory software applications (i.e., LIMS and data acquisition software).
  • Demonstrated ability to apply knowledge and skills in a collaborative research environment.
  • Demonstrated competence in the preparation of peer-reviewed scientific publications and presentations.
  • Excellent interpersonal written and oral communication skills and the ability to interact directly with internal and external scientists.
  • Familiarity with global regulatory guidance (e.g., Food and Drug Administration (FDA), Organization for Economic Co-operation and Development (OEDC), European Medicines Agency (EMA), International Council for Harmonization (ICH) as applicable for scientific discipline
  • Working knowledge of GxPs and industry guidance documents.
  • Ability to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended shifts and/or extra shifts, sometimes on short notice.
  • Familiarity with Microsoft Office Suite.
  • Ability to work under specific time constraints.

Senior Project Coordinator

Full-time

Position Summary:

The Senior Project Coordinator is responsible for assisting the Project Management team as assigned, with the responsibilities relevant to contracted projects/studies.

Scope & Impact:

This position supports the Project Management team in tasks required by the study protocol and contract to ensure adherence to quality and study timelines.

Major Responsibilities:

  • Serve as back-up to project managers and take on individual project assignments as necessary to support the business
  • Support for managing project specific financials (revrec, change orders, budgets)
  • Support Project Manager in conducting the kick-off meeting and other study team meetings with internal and external study team members
  • Regularly review the status of site qualification, image processing and query management to meet study timelines
  • Coordinate with site/center qualification team with providing site contact lists and helping with determining the readiness and prioritization with setups
  • Alert the project manager of any resourcing or timeline issues
  • Assist with managing the data reconciliation process
  • Interact with the reader management team and provide read status to Project Managers
  • Support Project Management meetings by taking and distributing meeting minutes
  • Develop and distribute weekly trackers as required for internal and external distribution
  • Provide eligibility confirmation and approvals to scan to sites, to include qualification reports
  • Support iCRO To Do report for upcoming deliverables
  • Support development of study documents (e.g., Electronic Technical Binder, Communication Plan, Project Plan)
  • Supporting site set-up and dose ordering, as applicable
  • Support distribution of training materials
  • Act as back-up by interfacing with external and internal teams in Project Manager’s absence
  • Perform other duties as assigned by supervisor

Qualifications:

  • Associates Degree; Bachelor Degree (preferred)
  • Strong communication skills
  • Clinical trial experience preferred
  • Medical Imaging experience preferred
  • Excellent grasp of SOPs
  • Excellent organizational skills
  • Detail oriented
  • Experienced in Microsoft Office tool set
  • Exhibits ability to exercise good judgment

Invicro is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity.

Medical Writing Manager

Full-time

Position Summary:

The Medical Writing Manager will develop, create, edit, and coordinate the production of image review charters and reader manuals, technical operations manuals and other critical study documents that may or may not be associated with submission to a regulatory agency.  This development includes the management of a library of reusable text based on therapeutic area, analysis methods and other relevant criteria.  In addition, this role and associated staff will be support the development of templates of imaging documents as requested by operations leadership. The Manager is responsible for all line management of assigned medical writing staff as well a project prioritization with input from operations leadership.

Scope & Impact:

This position works with internal project teams and external stakeholders to develop the necessary language to support the development of charters, reader manuals and imaging operations templates.  The manager will bring structure to the development and tracking of these critical documents and well as reusability of language to efficiently develop these documents in a timely manner.

Major Responsibilities:

  • Author Imaging Charters based on details pulled from the study protocol and in collaboration with sponsor teams based on regulatory guidelines document with respect to content
  • Author Reader Manuals to support the reader training process based on imaging charter, analysis eCRF and visualization software being used
  • Author final Study Reports if applicable
  • Develop imaging document templates as required by operational leadership to create efficiencies and development of standard look and feel across documents
  • Develop a standard library of reusable text to create efficiencies in document authoring
  • Author Standard Operating Procedures and Work Instruction Documents for Medical Writing group as necessary
  • Coordinate sign-off of document deliverables according to appropriate SOPs\WIDs, including distributing drafts, chairing round table meetings, and incorporating revisions
  • Perform quality control review such as copy editing, content editing, and number checking for other writers as necessary
  • Perform literature searches/reviews and research current guidelines as necessary to gather background information and training for development of documents
  • Attend internal technical team and client team meetings as required
  • Serve as Medical Writing representative on assigned Project teams
  • Regularly communicate project related issues with Medical and Scientific teams and the project team, as appropriate
  • Provide leadership, delegation of responsibilities and tasks to team members
  • Monitor workload to ensure direct reports can reasonably manage assigned task to meet project timelines
  • Manage performance of direct reports and conduct performance reviews
  • Participate in recruitment/interview process for new hires within the medical writing team

Qualifications:

  • Bachelor’s degree in Life Sciences/Health Related Sciences or equivalent
  • Medical/technical writing experience of at least 5 years in a clinical research setting
  • Previous line management experience
  • Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines
  • Able to work independently
  • Attention to detail and ability to multitask
  • Strong written and oral communications skills, as well as excellent interpersonal and negotiation skills
  • Knowledge of resource management and productivity metric management
  • Strong word processing skills including familiarity with MS Office production for documentation and presentation development

Invicro is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity.

Registered Nurse – Clinical Research

Full-time

Overview:

The research nurse is primarily responsible for study coordination and data management oversight. His/her central focus is on managing subject recruitment and enrollment, consistency of study implementation, data management and integrity, and compliance with regulatory requirements and reporting. This position requires interactions with subjects, clinical research staff and staff from the regulatory and data management areas of the company.

Responsibilities:

  • Completes study visit activities including EKGs, phlebotomy(blood draws), and vital signs
  • Detailed understanding of Phase I-IV drug development
  • Participates from study initiation through the close-out process
  • Responsible for recruiting and scheduling of study participants
  • Conducts and assists with study procedures, including but not limited to the administration of investigational drugs, performance of investigational imaging procedures and lumbar punctures
  • May supervise other junior research staff

Qualifications

  • Current Connecticut state licensure as a registered nurse
  • Experience with EKG’s, Blood Draws, and taking Vital Signs
  • Bachelor’s Degree in registered nursing &/or equivalent experience in a related field
  • Knowledge of Good Clinical Practices (GCP) and other Regulations

Physical requirements/environmental factors:

  • Ability to lift 20-25 lbs
  • Travel to Investigator meetings may be required
  • Exposure to human bodily fluids

Invicro is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity.

Technical Project Manager – Image Analysis

Full-time

Overview:

The Technical PM is responsible for interfacing with Project Managers and Developers on a variety of imaging studies and technical projects. The Technical PM is expected to have a full understanding of all typical workflows within Invicro’s Image Analysis (IA) and Project Management groups. The Technical PM is also responsible for planning, executing, and finalizing solutions related to new and existing projects, phased functional enhancements, workflows, analysis integration methods, modules and services. Other duties may include editing or creation of SOPs, internal development tasks, and training employees on tools developed for project management.

Responsibilities:

  • Facilitate connections between the Project Management and Image Analysis teams
  • Testing, implementation, validation, and training of software tools developed for Project Management
  • Ensuring the quality of all processing and output materials
  • Editing and creation of SOPs
  • Effective communication both within the department as well as with other departments and other sites/sponsors
  • May work on supervised or open-ended development tasks

Qualifications and Skills:

  • Master’s Degree or Bachelor’s with 2+ years’ experience
  • Degree in physics, mathematics, engineering, or related field
  • Strong communication and problem-solving skills

Critical:

  • Coding/scripting experience (MATLAB, Python, or related)
  • Highly organized

Nice to have:

  • Imaging background
  • Project Management experience
  • Experience peripheral to pharma

Invicro is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity.

Senior Compliance Manager

Full-time

Overview:

The Senior Compliance Manager will provide direction for the development, execution, and compliance of the Company’s Quality Assurance program to comply with all appropriate quality regulations. The position is responsible for internal and external auditing and reporting on the management and/or performance of all GMP, GLP, GCP (GXP) QA functions. This position supports Invicro’s QA program, which is imperative to ensure adherence to federal, state and international regulations and standards.

Responsibilities/Knowledge Required:

  • Assist with inspection readiness, and regulatory inspections as needed
  • Hosts and/or supports customer audits and ensures appropriate and sustainable action plans are developed and implemented.
  • Oversee the audit response and ensure acceptability of actions to address findings through the CAPA process
  • Conduct and/or assist in internal audits (systems, processes, vendors, computer system validation)
  • Interact with contract auditors in the scheduling process, kick-off meetings with auditors and internal groups, assist in the drafting of audit plans, confirmation letters and agendas, etc.
  • Experience in vendor management (min. 5 years’ experience preferred)
  • Perform audits and help manage the qualification of external vendors to ensure compliance with applicable regulations and standards.
  • Draft, review or revise SOPs to assess consistency and compliance with regulatory requirements/internal standards
  • Attend cross-functional team meetings and provide guidance to staff based on interpretation of current regulations to ensure best practices including risk-based management
  • Perform root cause analysis of compliance issues and provide the appropriate metrics for tracking and trending for the overall QA reporting requirements to functional and senior management
  • Work with the Director of Compliance to serve as a back-up and to help manage the Quality Management System and related processes.
  • Work with QA leadership to provide training, knowledge management, and strategic quality consultation to internal and external customers as needed.

Professional Competencies:

  • A well organized, self-motivated and independent work style with the ability to initiate and follow through on assignments
  • Excellent interpersonal skills with knowledge of basic negotiation, influencing and conflict management to assure effective interactions within and across departments
  • The ability to simultaneously handle multiple project issues while dealing with time demands, incomplete information, or unexpected events
  • A strong team player is required with the ability to effectively communicate sound Quality advice cross-functionally based on experience, regulations & business needs
  • Experience with using risk-based principles & decision making to ensure compliance at all stages of development
  • Proven track-record of leadership & building relationships with both internal & external customers
  • Effective communication and organizational skills
  • Strong oral and written skills

Education/Experience:

  • Bachelors level degree in a scientific or life sciences discipline
  • A minimum of 5+ years of relevant and increasingly responsible experience in the Biotech/Pharmaceutical Industry in a GCP quality role and compliance
  • CQA, or equivalent, certification preferred
  • 3-5 years management experience preferred

Invicro is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity.

Quality Assurance Associate – Chemistry

Full-time

Purpose of the position/Job Summary:

The QA Associate-Chemistry (External Manufacturing QA) is responsible for performing various QA analyses on company products, ensuring the quality and integrity of the finished product, production/QC data in support of CMC and other FDA submission documents.

Scope & Impact:

This individual will work closely with Regulatory Affairs and the Chemistry groups to enhance quality systems and methods for documentation of the adherence to company procedures, Good Clinical Practice, Good Manufacturing Practice, 21CFR Part 212 and other regulatory requirements. The incumbent will also interact with external site manufacturing personnel. Research involving human participants, and the development and use of radio-pharmaceuticals, requires the timely and precise organization of regulatory documents.  It is imperative that regulatory documentation reflect the changing requirements of regulations and Invicro’s interpretation of those changes.  This position will help ensure that all chemistry products (External Manufacturing) for human use are safe and of high quality.

Major responsibilities:

  • Review and approve external manufacturing batch records.
  • Track and organize documents for batch record closure.
  • Organize external manufacturing documents.
  • Track documents for localization distribution.
  • Track OOS/deviation findings, report noticed trends to supervisor. Support company CAPA program.
  • Assist in audit activities as required.
  • Assist in review of external manufacturing procedures.
  • Ensure all external manufacturing processes are covered in SOPs and WIDs and maintained in accordance with regulations.
  • Assist in chemistry technology transfer and process validation activities.
  • Support Project Management’s interactions with external manufacturing sites.
  • Assist in assuring consistency between sponsor’s and external manufacturing sites’ quality agreements.
  • Assist in updating External Manufacturing QA documents at appropriate review cycles.
  • Maintain current documentation of training for external manufacturing sites.
  • Keep current with industry guidelines and regulations.
  • Other tasks as assigned by supervisor.

Qualifications:

Required:

  • Minimum of a Bachelor’s degree with 2-years’ experience in a comparable environment.
  • Must be highly motivated and detail oriented.

Preferred:

  • Biology or Chemistry background

Unique Department Requirements:

  • Works in an environment with radiopharmaceuticals
  • Due to location of manufacturing sites, there will need to be some flexible shift schedule requirements.

Invicro is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity.

 

Full Stack Web Developer

Full-time

Overview:

Make an impact at a dynamic and growing life sciences company!

Invicro’s mission is to develop smarter drug discovery programs and we are currently seeking an energetic and solidly technical and creative professional to be part of a team of highly motivated and skilled product engineers.

The Full Stack Web Developer will extend our web-based study management and storage application (iPACS). iPACS is a platform used by researchers worldwide to provide tools for managing, data mining and reporting on large amounts of medical imaging data. A flexible solution developed for both in-house and external applications, iPACS is currently installed at more than half of the nation’s top 25 pharmaceutical companies.

This individual should enjoy challenging and analytical work and be motivated by the idea that together we can accomplish great things and make a positive contribution to society through the company’s mission.

Key Responsibilities:

  • Develop test, and maintain the iPACS business logic layer (Perl Moose, DBIx, Catalyst) and front-end layer (Vue.js/Vuex, jQuery, Bootstrap)
  • Work closely with the Product Manager and Scrum Master to assist in project planning, providing estimates and updates as necessary
  • Develop and maintain unit tests
  • Troubleshoot production issues on occasion
  • Expand the platform towards containerized, microservices based architecture

Qualifications and Skills:

  • Bachelor’s degree in Computer Science, related discipline or relevant experience may substitute
  • 2-5 years of work experience in complex systems design, application development and/or support
  • Strong knowledge of HTML, CSS, JavaScript and a server-side language (Python, Java, PHP, etc.)
  • Understanding of user interface best practices and standards
  • Familiarity with development and debugging tools
  • Experience with Modern Perl, Catalyst MVC Framework, and/or DBIx nice to have but not required

What We Offer

  • Competitive salary
  • 401k with generous matching
  • Flexible vacation policy
  • Catered lunch Wednesdays
  • “First Fridays” – monthly company-wide team updates and happy hour

Invicro is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity.

 

Perl Developer

Full-time

Overview:

Make an impact at a dynamic and growing life sciences company!

Invicro’s mission is to develop smarter drug discovery programs and we are currently seeking an energetic and solidly technical and creative professional to be part of a team of highly motivated and skilled product engineers.

The Perl Developer will extend our web-based study management and storage application (iPACS). iPACS is a platform used by researchers worldwide to provide tools for managing, data mining and reporting on large amounts of medical imaging data. A flexible solution developed for both in-house and external applications, iPACS is currently installed at more than half of the nation’s top 25 pharmaceutical companies.

This individual should enjoy challenging and analytical work and be motivated by the idea that together we can accomplish great things and make a positive contribution to society through the company’s mission.

Key Responsibilities:

  • Develop test, and maintain the iPACS Data Model (DBIx)
  • Implement the iPACS business logic layer (Perl Moose, Catalyst)
  • Assess, improve, and maintain iPACS environment (including server, network, and hosting environment)
  • Develop unit tests using the Test::More testing framework
  • Work closely with the Product Manager and Scrum Master to effectively plan projects for the team, providing updates as necessary
  • Actively participate in code reviews
  • Estimate features and contribute to product roadmap
  • Partner with the team on writing/approving user stories, including driving technical decisions from the users’ perspective.
  • Train, mentor and eventually lead other developers on industry standards and best practices
  • Troubleshoot production issues on occasion
  • Expand the platform towards containerized, microservices based architecture

Qualifications and Skills:

  • Bachelor’s degree in Computer Science, related discipline or relevant experience may substitute
  • Demonstrated experience with Modern Perl, Catalyst MVC Framework, DBIx::Class, and Template::Toolkit.
  • 3+ years of work experience in complex systems design, application support, and network security
  • Strong knowledge of HTML, CSS, and JavaScript (OO JS, DOM manipulation, AJAX, JSON)
  • Understanding of user interface best practices and standards
  • Familiarity with development and debugging tools
  • Preferred (but not required) knowledge of computer system hardware and software validation in GxP environments

What We Offer

  • Competitive salary
  • 401k with generous matching
  • Flexible vacation policy
  • Catered lunch Wednesdays
  • “First Fridays” – monthly company-wide team updates and happy hour

Invicro is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity.