Join Impel

Responsibilities include the following.  Other duties may be assigned.

• Lead scientific, technical, and business-related risk assessments to assist in CRO selection and evaluations, including leading and managing the Request for Proposal process
• Perform CRO on-site assessments of CROs for pharmacokinetics, toxicology, safety pharmacology, and developmental and reproductive toxicity studies

• Design, supervise, analyze, interpret, and report in vivo non-GLP and GLP studies conducted at CROs including PK, toxicology and safety pharmacology studies in collaboration with study monitors and other scientists. Ensure appropriate quality of documentation and record keeping are compatible with global regulatory submission requirements.

• Work collaboratively with CROs and internally across-disciplines to coordinate study timelines and deliverables
• Accountable for critical documents including study protocols, reports, nonclinical sections of regulatory documents. May contribute to manuscripts and regulatory submissions.
• Candidate should have strong critical thinking and research skills and a desire to conduct early development /mechanistic studies as well as GLP-compliant IND enabling toxicity studies.
• Develop and maintain cross-departmental collaborations and shared work practices across functional groups and participate in project teams.
• Contribute to departmental processes such as SOPs and templates.

Qualifications

• Ph.D. in Pharmacokinetics/Pharmacology/ Toxicology/ Biological Sciences or related discipline with 2+ years of biotech, pharmaceutical industry or CRO experience; MS +5 years experience or BS with +8 years experience.
• Demonstrated comprehensive knowledge of designing, conducting and interpreting nonclinical PK, PD and toxicology studies.
• Strong knowledge of nonclinical drug development, FDA and ICH guidances, and GLP regulations.
• Direct experience working on multidisciplinary drug development project teams and comprehensive knowledge of drug development strategy.
• Outstanding organization and planning skills, and the ability to multi-task and understand project team deliverables.
• Proficient at critically reading and applying relevant scientific literature.
• Excellent analytical and soft skills to interact effectively and harmoniously with vendors and stakeholders.
• Proven ability to thrive in a collaborative team environment: strong oral and written communication skills, and a helpful team spirit.
• Demonstrates a sense of urgency, proactive and creative thinking, and productivity in a fast-paced, innovative and team-oriented environment.
• Travel required up to 30% per year to monitor outsourced studies (domestic and international.)

ACCOUNTABILITY OBJECTIVE:

The primary responsibility for this position will be managing/directing the Clinical QA activities to support GCP and Clinical Trial obligations.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• • Meet the ongoing needs of the quality assurance department by maintaining CQA compliance for ongoing and planned clinical trials.
  • Lead investigations and write CAPAs on GCP issues as they arise.
  • Ensure proper maintenance of the Quality systems.
  • Directly interface with Clinical Operations to provide support for vendor, site, and internal GCP audits.
  • Work with clinical operations and regulatory affairs to review IND and NDA submission documents.
  • Responsible for ensuring submission data and documentation meets GCP guidelines.
  • Perform and/or support audits of clinical sites, CROs and other clinical vendors.
  • Assist in authoring clinical operation SOPs and processes as needed.
  • Develop and support established records management procedures.
  • Provide input and change management for quality improvements affecting CQA systems.
  • Assist with writing and editing documents needed for the clinical quality management system.
  • Update and maintain CQA SOPs that support the quality systems.
  • Manage and update electronic libraries.
  • Facilitate meetings with CRO’s and other clinical entities as appropriate.
  • Ensure Trial Master Files are maintained within standards.
  • Other duties as assumed or assigned.

EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED

• • Bachelor’s degree
  • Education and experience in an FDA-regulated environment.
  • Ten (10) years of related quality or clinical experience in a similar environment.
  • Broad knowledge of clinical processes and procedures, electronic documentation systems, and Good Clinical Practices 21CFR Parts 50, 56, and 312.
  • Demonstrates initiative and proactively provides collaborative support to the clinical teams.
  • Ability to plan and organize work in an efficient manner and work well under time constraints.
  • Demonstrates effectiveness in maintaining CQA control systems for compliance with FDA regulations.
  • Must have experience using MS Office
  • Experience in MasterControl or a similar ECM system is a plus.
  • Willing to travel 20-30%.

PHYSICAL DEMANDS

This is a fast-paced environment with moderate noise level. Limited travel may be required.

WORKING CONDITIONS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Must have demonstrated ability to multitask in high pressure, changing conditions. Ability to use computer, telephone, and other office machines

 ACCOUNTABILITY OBJECTIVE:

This position will research regulatory strategies, draft, edit, format, and finalize in coordination with Regulatory and other disciplines as required, regulatory feasibility reports, FDA meeting request letters, meeting packages, package inserts instructions for use, and sections of IND or NDA submission documents. Other documents may include publications, “White Papers”, position statements, abstracts/presentations and other regulatory materials as required.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Provide research to support regulatory documents including data output
• Incorporate internal and external data into strategic regulatory documentation
• Perform literature searches related to documents and presentations in development; and in support of other departments
• Support the generation of Meeting Request Letters, Meeting Packages, and other regulatory documentation such as Fast Track or Orphan drug submissions
• Support the preparation of Target Product Profiles and transition to Package Inserts and Instructions for Use
• Support the generation of sections of IND or NDA dossiers for submission to the Regulatory authorities
• Perform other duties as assigned

EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED

• Advanced degree (MS, MD or PhD) in a relevant scientific field
• 5+ years documented medical or scientific writing experience in academia, pharma, biotech or a CRO setting
• In-depth knowledge of Good Clinical Practices, FDA regulations, MHRA regulations, ICH guidelines and the drug development process
• Familiar with principles of Good Documentation Practice
• Strong computer skills (Word, Excel, PowerPoint, and Adobe Acrobat) and the use of templates
• Excellent written and verbal communication skills, with the ability to clearly present clinical data
• Strong organizational skills with the ability to effectively multi-task and prioritize
• Flexibility/adaptability to working in a fast-paced and dynamic environment and to changing business needs and deadlines
• Strong attention to detail and ability to complete writing assignments in a timely manner
• Ability to work independently and collectively in teams

PHYSICAL DEMANDS 

This is a fast-paced environment with moderate noise level. Limited travel may be required.

WORKING CONDITIONS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Must have demonstrated ability to multitask in high pressure, changing conditions. Ability to use computer, telephone, and other office machines 

Senior Clinical Data Manager

ACCOUNTABILITY OBJECTIVE:

Reporting to the VP Clinical Development, the Senior Clinical Data Manager is responsible for managing the clinical trial data for multiple assigned projects.  The successful incumbent will act as liaison between Impel and CRO personnel to implement and maintain clinical databases, and ensure data integrity and conformance with current standards.  S/he will collaborate on project or software-related training, and coordinate internal planning and activities such as medical coding, electronic data transfer, and all other aspects of data cleaning.  This individual will provide project oversight of daily, weekly and monthly data management tasks and CRO deliverables to ensure assigned projects and deliverables are on track, delegating tasks (as needed) to other team members.  Additionally, s/he will serve as a technical resource to colleagues, troubleshooting technical problems and ultimately managing more complex projects.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:

• Act as Lead Data Manager on Impel clinical studies
• Design, or oversee the CRO’s design of, an Electronic Data Capture (EDC)/Data Management system, including the design/review of Case Report Forms and system edit checks
• Develop User Acceptance Testing (UAT) Plans and coordinate with team members to perform UAT
• Develop and/or review Data Management Plans (DMPs), outlining and confirming all data management responsibilities
• Oversee the completion of data entry, including tracking CRF data entry, query generation/resolution
• Work with the study team, e.g., Clinical Development, Biostatistics, Regulatory, and/or CRO, to complete comprehensive, timely data review and resolve data issues
• May develop ad hoc listings, patient profiles, and/or additional data checks using software such as SAS, J-review, or other software
• May perform coding of medical events/medications
• Conduct/oversee database lock activities: ensure all database lock activities are performed prior to final database lock, oversee generation of CRF archival files, ensure project documentation is provided to Impel and filed, if applicable
• Review and/or conduct and document project-specific training for all team members prior to project start and throughout the course of the project, as needed
• Train or coordinate training for end users on the applicable EDC/ Data Management system, maintaining current system access and ensuring all training records are up to date. May perform study specific CRF training at Investigator Meetings
• Coordinate and delegate work performed by study data managers, as needed; assist in mentoring of more junior data managers
• Lead writing/reviewing/updating Data Management related Standard Operating Procedures (SOPs) and oversee training of appropriate staff in their interpretation and use
• May prepare and present data management topics to Clinical Development and other Impel departments
• Lead assessment and selection of data management systems, if applicable

EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED:

• Bachelor’s degree in a related field of study preferred
• 10+ years leading DBM study activities or equivalent combination of education and experience
• Certified Clinical Data Manager (CCDM) is an asset
• SAS programming is an asset
• Minimum 5 years’ experience with Medidata Rave. Experience with other platforms (e.g. Oracle Inform) beneficial
• Experience working within a Sponsor environment, overseeing vendor and contract management
• Experience writing, reviewing and editing EDC specifications to assure alignment with clinical protocols and SAPs
• Knowledge of Good Clinical Practice (GCP) and FDA regulations is expected
• Proficiency in Microsoft Office; Word, Excel, PowerPoint, Outlook
• Strong attention to detail and ability to effectively prioritize tasks and assignments to meet deadlines
• Excellent written and verbal communication skills, including ability to effectively present information and respond to questions from project teams, executive management, external vendors, KOLs, and customers
• Ability to exercise judgment and determine appropriate action
• Ability to work independently and unsupervised and manage deadlines

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  Must have demonstrated ability to multitask in high pressure, changing conditions.

WORKING CONDITIONS

This is a fast-paced environment with moderate noise level.  Limited travel, mostly national, may be required.

STATUS:  Temporary (90-days), part-time, 20-hours per week

ACCOUNTABILITY OBJECTIVE:

As Impel has grown, so have the Environmental Health & Safety requirements, including the time and effort needed to put important processes, training, and documentation into place that are required by city, state, and federal law.  With oversight from the current Safety Committee Leadership, this person will implement a formal EH&S program that ensures compliance with regulations and continues to provide an enjoyable and safe workplace to Impel employees.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned:

• Develop and implement safety programs including but not limited to; accident prevention and reporting, behavior-based safety process, ergonomics, hazard communication, hazardous energy controls, confined spaces, lock-out tag-out, emergency evacuations, industrial hygiene monitoring, fire prevention, property conservation, accident investigation and analysis, SDS control and record keeping.
• Develop, implement and train policies and standard operating procedures (SOPs) in accordance with Impel’s safety programs.
• Establish continuous improvement programs for Environment and Sustainability initiatives, including but not limited to air emissions, liquid and solid hazardous waste management, chemical storage tank management, pollution prevention, communication right to know reporting, hazardous material storage, energy/water conservation, radiation services, and emergency preparedness/response.
• Build EHS capability through creation and implementation of an EHS training program.
• Establish self-improvement audits and metrics to promote EHS and create a sustainable EHS culture within the Impel organization.
• Provide EHS subject matter expertise to functional heads and staff to interpret regulations, manage risk and train Impel staff.
• Develop, modify and execute policies that affect operations and may also have company-wide effect.
• Act as primary contact/liaison for administrative commitments and required agency reporting for all EHS regulatory agencies, and the emergency coordinator representing the site during all interaction with EHS agencies, including local municipality services during catastrophic industrial and weather-related events.
• Establish a risk management framework and risk assessment procedures to enable the organization to identify and address potential environmental and safety concerns before the employees or company is put at risk.
• Forecast and coordinate EHS activity around equipment layouts, building designs and process improvements, acting as integral part of project teams.
• Propose annual budget for departmental expenses, employee requirements and capital equipment.
• Regularly interact with employees and management on matters concerning EHS activities.  Will require an ability to change the thinking of or gain acceptance of others in sensitive situations.
• Review new and revised EHS legislation and make recommendations to EHS Committee to maintain EHS policies and procedures.

EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED

• Bachelor’s Degree or equivalent experience required in Safety, Industrial Hygiene, Environmental, Engineering or related field of study
• Knowledge of cGXP/FDA/OSHA/EPA regulations, other applicable EHS international standards, and Federal, State, and Local regulations
• Prior laboratory experience
• 3-5 years of experience with risk assessments, risk management, personnel protective equipment, injury and incident investigation, reporting, industrial hygiene, auditing, behavior-based safety and training
• Strong written and verbal communication

The following elements are preferred:

• Pharmaceutical industry experience
• Sustainability program management experience
• EHS leadership/management experience
• Facilities background

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Must have demonstrated ability to multitask in high pressure, changing conditions. Sitting, standing, stooping, and lifting of packages/laboratory equipment up to 30 pounds may be required.

WORKING CONDITIONS

This is a fast-paced environment with moderate noise level.