Careers

Corbus's Culture

Corbus Pharmaceuticals, Inc. is a close-knit team of 30+ employees. We are looking to add to our growing "family" with fellow high-achievers who are innovative, creative and passionate about what they do. We hire for personality as well as for skill. We are very serious about the science, but also enjoy having fun together.

You must be the type of person who thrives in an entrepreneurial and autonomous environment where success is based on your contribution and work ethic and not on title or rank. No politics. No red tape. Everyone is hands on and contributes equally. Keeping a positive, team-oriented culture is very important to us as we all enjoy coming into work each day and making a difference. Creative perks like a monthly in-house massage therapist for employees, company outings, companywide celebrations of success as well as an excellent benefits package help make Corbus a special place to work.

Finally, the leaders at Corbus believe in empowering their employees. We seek confident (but humble) high performers who are driven by success and want to make a difference by being part of a leading-edge biopharmaceutical company.

About us

Corbus Pharmaceuticals Holdings, Inc. is a Phase 3 clinical stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat rare, chronic, and serious inflammatory and fibrotic diseases.

Please contact us at hr@corbuspharma.com for further information or to submit your resume.

Open Positions:

We seek an experienced Co-op to contribute to the success of small molecule drug pipeline. You will support chemical manufacturing development activities including characterization and control for drug substance manufacturing in a virtual pharmaceutical development setting.

This position will report to Process Development and Manufacturing Lead.

The co-op job responsibilities include:

  • Prepare technical documents (procedures, reports and presentations).
  • Propose chemical mechanisms and potential impurities that could likely form during manufacturing.
  • Research topics of interest (Scifinder, internet, …etc.)
  • Responsible for data organization and filing.

Education and experience requirements:

  • At minimum, currently in a B.S. program for analytical, physical or organic chemistry.
  • In-depth knowledge of liquid and gas phase (GC and LC) analytical techniques.
  • Knowledge of MS, NMR, HPLC, IR, GC, XRPD, TGA, DSC, would be preferred.
  • Hands on experience in chemical laboratory would be preferred.
  • Experience with analytical methods HMR, HPLC, IR would be preferred.
  • Excellent interpersonal, verbal and written communication skills.
  • Comfortable in a fast-paced environment and able to adjust based upon changing priorities.

Location: Norwood, MA

Corbus Pharmaceuticals, Inc. is an equal opportunity employer.

This is a new position based on growth

Roles and Responsibilities:

  1. The CRA will be the primary point of contact for investigator sites, and will be responsible for ensuring the clinical trial is being conducted according to CFR, ICH guidelines and GCP.
  2. The CRA will be responsible for the efficient execution of monitoring and other clinical trial management activities, will track the progress of assigned studies/projects and will proactively identify potential challenges and will develop appropriate actions to resolve issues and achieve target objectives. Other potential responsibilities of the CRA include but are not limited to the following:
    • Will perform investigator site pre-study site qualification visits including collection of site regulatory documents.
    • Will assist with site start-up activities including: site contracts and budget development/negotiation, preparation of IRB submissions (including follow through to ensure successful outcome).
    • Will be responsible for the preparation of the study reference manual, including liaising with contract research organization team (including central lab, specialty labs and vendors) to ensure efficient preparation and delivery of study materials to investigator sites.
    • Will be responsible for ensuring investigator sites have met all contractual and regulatory requirements for site initiation and first release of study drug.
    • Participates in/leads the Investigator/Initiation Meetings and ensures that the study staff conducting the study have received the proper materials, instructions and training to safely and accurately conduct the study in-line with protocol requirements.
    • Will assist in the development of study/program plans (e.g., Monitoring Plan, eCRF Completion Guidelines, Data Management Plan, Safety Management Plan, etc.).
    • Will track the movement of laboratory samples and the resulting data; including the transshipment of samples to specialty laboratories, or movement of samples to sample management storage.
    • Will manage patient recruitment strategies, or pro-actively identifies barriers to recruitment and propose solutions (e.g., study site webinars, newsletters, or other potential creative solutions).
    • Will monitor recruitment, data quality, and patient safety while on site and remotely through EDC systems and direct site communication.
    • Liaise with study site personnel to ensure timely and correct entry of data into eCRF, including the timely resolution of data queries.
    • Maintain project files including: ethics committee approvals; curricula vitae of investigators and study personnel; clinical investigators brochure; protocols; case report forms instructions; consent documents; clinical trial material shipping orders; start-up meeting attendance documentation; letters of agreement; lab reference ranges; all investigator and site correspondence; and schedules of payment.
    • Identifies and completes follow- up of SAEs at study sites.
    • Assists with data listing, data coding, and patient profile reviews, and database lock, and site close-out activities
    • Ensures appropriate and timely submission of documents to the Trial Master File.

Requirements:

This is an office based position that will include travel

The successful candidate for this role will be a self-motivated individual able to work in a small team environment, able to independently identify tasks/issues that need to be addressed. The successful candidate will be a highly organized individual who can also multitask and adjust direction based on changing project/corporate priorities. Other desired experience and characteristics of the successful candidate include:

  1. BS/BA degree is required.
  2. 2-6 years field based monitoring or other relevant experience is preferred.
  3. Thorough knowledge of ICH/GCP guidelines.
  4. Strong written and verbal communication.
  5. Must have strong PC skills (MS Word, MS Excel, MS Project)
  6. Working knowledge and experience with electronic data capture (EDC) systems and CTMS is preferred.
  7. Experience with Outsourced Clinical Trials is required.
  8. Ability and willingness to accommodate at least 25-50% travel based on assigned project requirement

This is a new position based on growth

Roles and Responsibilities:

  1. Assists the Study Team across all investigator sites and ensures compliance with protocol and overall clinical objectives.
  2. Performs project/study management related responsibilities by coordinating and tracking activities for clinical trials in compliance with protocol, Standard Operating Procedures (SOPs) and regulatory guidelines from the inception of the protocol through database lock process. This involves working closely with all functional areas as well as external providers to ensure consistent high quality study outcomes.
  3. Other potential responsibilities of the CTA include but are not limited to the following:
  • Throughout the study, ensures that study activities are executed according to the study protocol, regulatory guidelines, and operational plan.
  • Reviews Investigational Drug Brochures (IDB), Protocols, Case Report Forms (CRFs), and informed consent forms (ICFs) for a thorough understanding of the study drug and procedures.
  • Keeps abreast of SOPs, Good Clinical Practice (GCP) and ICH guidelines, state and national laws and ethical standards.
  • Participates in study start-up, conduct, and closeout activities.

    a. Assists with the preparation of vendor requests for proposals, and tracks receipt of proposals, MSAs, and SOWs
    b. Collects and reviews site regulatory documents for accuracy and completion (1572, Financial Disclosure documents, CLIA waivers, etc).
    c. Assembles and distributes regulatory binders to clinical sites
    d. Drafts and/or assists with the preparation of trial-related documents, tools and templates (start-up forms, screening scripts, source documents, study logs).
    e. Supports project management activities including taking meeting minutes/providing agendas to the clinical team, tracking screening/enrollment across all sites, and maintaining study status trackers.
    f. Assists with the preparation and distribution of investigator site contracts and budgets.
    g. Maintains the Trial Master File for all clinical projects.

Requirements: 

The successful candidate for this role will be a self-motivated individual able to work in a small team environment, able to independently identify tasks/issues that need to be addressed. The successful candidate will be a highly organized individual who can also multitask and adjust direction based on changing project/corporate priorities.

Other desired experience and characteristics of the successful candidate include: 

  • BS/BA degree in health sciences related field is preferred, but not required.
  • Excellent written and verbal communication skills. 
  • Must have strong PC skills (MS Word, MS Excel, MS Project) 
  • Sound analytical and problem solving skills 
  • Ability to act with a consistent sense of urgency with and acute attention to detail 
  • Working knowledge and experience with electronic data capture (EDC) systems and CTMS is a plus.
  • Prepare technical reports and presentations as necessary.
  • Responsible for reports and data organization and filing.

Location: Norwood, MA

Corbus Pharmaceuticals, Inc. is an equal opportunity employer.

WHO WE'RE LOOKING FOR

As a fast-growing and entrepreneurial pharmaceutical company, we are looking for an action-oriented individual who is looking to make a positive impact on the world through the work that they do.

Reporting directly to the CFO this is a highly visible and collaborative role. In short, we are looking for someone who's not afraid to challenge existing standards. We want someone who's driven to work hard, execute great work and who'll take the risks to get there. You will be unafraid to take on the multi-faceted roles of "doer", "thinker" and "dreamer."

The ideal candidate should feel just as comfortable working on strategic marketing objectives as they are managing the day to day execution of digital marketing campaigns or PR campaigns.

WHAT YOU'VE DONE

  • Bachelor's degree in Public Relations, Journalism, Communications or related business field
  • Minimum 1-2+ years of experience (can include internships) in Advertising, PR, Marketing or Communications

WHO YOU ARE:

  • Positive attitude and true team player
  • Motivated self-starter with strong communication and organizational skills
  • Highly organized and detail oriented professional
  • Strong communicator and innate ability to work in a fast paced, high energy start-up atmosphere
  • Strong analytical skills and project management skills
  • Excellent organizational skills
  • Able to take direction, respond positively to constructive criticism and integrate feedback into the final product
  • Able to work on multiple tasks simultaneously, nimbly move on from one task to another, and meet deadlines
  • Able to manage projects, contribute to teams and work as an individual contributor
  • Excellent PowerPoint/presentation and design skills
  • Excellent Excel skills with a focus on charts/graphs to support metrics
  • Excellent written, grammar and verbal communication skills

WHAT YOU'LL DO

  • There's never a dull day in social media and public relations, so you'll be ready to tackle new tasks - quickly and efficiently - as they pop up throughout the day
  • Help build and maintain relationships with key patient advocacy groups, professional associations, government agencies, patients ,investors and the public with the aim of educating constituents on the company and future products.
  • Manage communications through social media, corporate events and written and in-person outreach such as town halls and trade booths, fliers, blogs, etc. This positon will also be responsible for managing team metrics.
    • Create content and disseminate information on social media (Twitter, Instagram, LinkedIn, etc)
    • Media list development and management: We need to start telling our patients about the work we're doing. You'll have to do your research, and identify media targets for proactive outreach and company announcements
    • Coordinate with web team to update company website and other online materials
    • Support the development of collateral materials, such as media lists, communications materials to internal/external stakeholders, -news you can use- items, etc.
    • Working with subject matter experts to gather, curate and update existing corporate content, including slides, master messages and other internal/external materials.
    • Create and maintain databases to organize and keep track of outreach and a metrics tracking report to capture and measure results of team initiatives
    • Write occasional short features (spotlights) on new products or initiatives for internal and external online use
    • Manage team meeting agendas and logistics as needed
    • Act as coordinator for internal events such as functional town halls
    • Function as event planner and provide logistical coordination support for external events, including but not limited to identifying and managing corporate materials at event venues
    • Serve as primary point of contact to build and maintain collaborative, mutually beneficial interactions with key patient advocacy groups, professional associations, government agencies, patients and the public. Prioritize the organizations with which to partner. Proactively advocate Corbus' priorities and objectives with direct one-on-one meetings and ongoing contact. Identify synergies and support opportunities that advance Corbus' business objectives and the objectives.
    • Develop overall strategy relating to regional disease-state goals and therapeutic priorities. Additionally develop tactics that emphasize shared goals between Corbus and priority groups. Collaborate with Corbus Executive Management during the business planning process to create one-year and multiple-year strategies and tactical operating plans for advocacy opportunities for pipeline compounds and aligned with company goals.
    • Remain abreast of new developments in regulatory, legal and policy arenas that have an impact on the Corbus franchise. Inform and equip team members about policies through periodic updates and training.
    • Define and standardize best practices in patient advocacy and professional relations. Serve as an internal and external resource as appropriate and identify opportunities to maximize the value of investments in current and potential patient relations programs.
    • Liaise with key company personnel including executive management, to garner company support outreach programs. Participate in brand planning and product team discussions to ensure the plans include advocacy opportunities and leverage PAR's knowledge of diverse organizations and their needs.
    • Implement and maintain a database to track investor contacts and prior history of meetings
    • Maintain and update corporate presentations and investor fact sheets
    • Create appropriate budgets and monitor expenditures
    • Other duties as needed

This is a new position based on growth

Summary:

This is a highly visible and hands-on role in which you will report directly to the CSO and Founder.  You will be a key member of the team. You must be the type of person who can think like an entrepreneur as well as having a strong passion for all things Regulatory. This is a personality hire, as much as skill. Must be able to ‘think outside of the box’, be an innovator and a have a strong desire to succeed.

Key Attributes Necessary for Success:

  • An articulate, driven and entrepreneurial-type leader with superior interpersonal communication and presentation skills and executive presence.
  • An energetic, forward-thinking and creative individual with high ethical standards.
  • Experience working in a start up culture a plus.
  • A can-do attitude and ability to work collaboratively.

Position Responsibilities:

  • Provide leadership in design, communication and implementation of the Company’s overall regulatory strategy.
  • Manage interactions with and build positive relationships with all regulatory bodies to help assure rapid submission completion and approvals (U.S. and Euro).
  • Work closely with consultants and contractors to assure regulatory compliance activities.
  • Advise senior management on regulatory pathways and options.
  • Prepare and review regulatory communications including writing cover letters, annual reports, IMPDs, INDs, CTAs NDAs and DSURs.
  • Work closely with internal functions (clinical, non-clinical CMC, and management).
  • Manage and grow Regulatory function as needed.

Position Requirements:

  • Advanced degree in appropriate field with 5+ years Regulatory experience in bio-pharma and/or CRO.
  • Through understanding of U.S. and Euro regulatory requirements, and the operating characteristics of regulatory agencies and their staff.
  • Experience in developing or assisting in the regulatory strategy of all stages of drug development from IND to market approval.
  • Familiarity with accelerated regulatory pathways a plus.
  • RAPS Certification a plus.
  • Ability to identify and remedy key regulatory issues and to anticipate potential regulatory hurdles.

Location: Norwood, MA

Corbus Pharmaceuticals, Inc. is an equal opportunity employer.

This is a new position based on growth

Roles and Responsibilities:

  1. Will work with other team members to establish and maintain the company wide electronic document management system.
    1. Identify appropriate platform that is 21CFR11/ICH safe harbor compliant
    2. Implement platform, establish appropriate work process, and file structures
  2. Will be responsible for document migration, quality control and will work collaboratively with team members to:
    1. Create and maintain document control procedures;
    2. Develop and maintain document standards, for example, naming/numbering conventions;
    3. Ensure document management system files remain up to date;
    4. Ensure documentation and record keeping processes conform to GxP and other regulatory requirements, as well as approved procedures;
    5. Scans, verifies and archives legacy documents and records as needed;
    6. Develop and maintain document review and approval processes.
  3. The document control specialist will also:
    1. Support clinical team activities including, but not limited to:
      1. Participate in the creation of clinical SOPs, maintain team training records, and establish and maintain an SOP review schedule;
      2. Review, proof, and edit clinical documents in support of clinical development projects;
      3. Support study start-up by reviewing investigator site documents and ensuring required documents for site activation are complete and accurate;
      4. Will provide additional support and assistance on various tasks and projects as directed by management.

Requirements:

  • Demonstrated skill in quality control of documentation and/ or technical editing
  • Excellent oral and written communication skills
  • Strong organizational skills with high attention to detail and ability to manage multiple projects at any given time.
  • Strong process improvement mindset, passion for quality
  • Advanced Microsoft Word, Excel skills and Adobe Acrobat/Nitro
  • Experience in the use of Electronic Document Management systems
  • Knowledge of quality assurance/control methods, principles, and practices
  • Ability and desire to work in a fast-paced environment, and a demonstrated ability to adapt to rapidly shifting priorities.

Preferred

  • Working knowledge of FDA/ICH regulations
  • Coursework or experience in Quality Assurance/Control and/or Regulatory Assurance
  • Demonstrated skill in quality control of documentation and/ or technical editing

Location: Norwood, MA

Corbus Pharmaceuticals, Inc. is an equal opportunity employer.

Corbus’s Culture

Corbus Pharmaceuticals, Inc. is a close-knit team of 30+ employees. We are looking to add to our growing ‘family’ with fellow high-achievers who are innovative, creative and passionate about what they do. We hire for personality as well as for skill.  We are very serious about the science, but also enjoy having fun together.

You must be the type of person who thrives in an entrepreneurial and autonomous environment where success is based on your contribution and work ethic and not on title or rank. No politics. No red tape. Everyone is hands on and contributes equally.  Keeping a positive, team-oriented culture is very important to us as we all enjoy coming into work each day and making a difference.  Creative perks like a monthly in-house massage therapist for employees, company outings, companywide celebrations of success as well as an excellent benefits package help make Corbus a special place to work.

Finally, the leaders at Corbus believe in empowering their employees.  We seek confident (but humble) high performers who are driven by success and want to make a difference by being part of a leading-edge biopharmaceutical company.

About us:

Corbus Pharmaceuticals Holdings, Inc. is a Phase 3 clinical stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat rare, chronic, and serious inflammatory and fibrotic diseases.

Job Description:

This is a newly created position based on growth

The Medical Writer is responsible for various medical writing initiatives as assigned by the Chief Medical Officer.  The Medical Writer is responsible for ensuring all documents are written in accordance with applicable regulations.

Duties and responsibilities:

Provide medical writing and editing expertise for regulatory submission documents (e.g., end-of-Phase2 meetings, expedited review applications, Pediatric Investigational Plans, clinical study reports, investigator brochures, meeting packages, IND applications, sections of marketing applications [NDA/MAA/CTD], patient
information guides, instructions for use, and pharmacovigilance documents).

Write, review, and edit clinical and technical documents for organization, clarity, language/grammar, consistency, and scientific standards.

Coordinate, synthesize, and integrate scientific and medical input from internal and external contributors to meet deliverable and publication deadlines for clinical documents, manuscripts, abstracts, presentations, etc.

Author documents while contributing therapeutic expertise, knowledge/skills related to     clinical drug development, and scientific/technical expertise.

Requirements:

Knowledge of FDA and EMEA regulations, GCP, ICH guidelines.

Excellent computer skills, with experience using Microsoft Office (Word, Excel, PowerPoint) applications to prepare charts, tables, forms, reports, and presentations. Experience with e-mail and calendar programs required.

Experience in performing medical-database searches (e.g., Medline, PubMed, etc.).

Qualifications:

PhD / MS in a Life Science or equivalent

5+ years medical writing experience

This is a new position based on growth

Responsibilities

  • Provide leadership and expertise to Company's clinical and medical monitoring programs; build effective relationships with site investigators
  • Lead safety surveillance, risk management and risk communication activities including medical reporting and assessment of adverse events
  • Develop risk management profiles.
  • Write protocols while working closely with CMO
  • Review and provide medical/safety input of PBRER, DSUR, clinical expert statement, etc.
  • Ensure that safety risks with projects, programs are rapidly identified analyzed and reported
  • Develop and direct overall drug safety operations processes to insure compliance with regulatory requirements U.S. and EMEA.
  • Effectively communicate with clinical operations/development staff, project management, IT, clinical QA, legal and other internal and external (CRO) staff and support
  • Thorough understanding of medical coding (MEDRA)

Requirements

  • Medical Degree with active U.S. medical license
  • Five + years experience in medical monitoring/drug safety PVG in a drug development organization (biotech, pharma, CRO)
  • Through understanding of the benefit/risk management implications of drug development
  • Experience with inflammation/fibrosis/immunology a plus
  • Personal integrity and a commitment to patient and study participant safety
  • Understanding of cross-function drug development/clinical trial process
  • First rate writing skills
  • Ability to thrive in a fast paced, entrepreneurial environment

Location: Norwood, MA

Corbus Pharmaceuticals, Inc. is an equal opportunity employer.