Project Manager, Clinical

Corbus Pharmaceuticals Holdings, Inc. Norwood , MA 02062

Posted 4 months ago

Project Manager, Clinical

The Project Manager, Clinical will identify, track, and integrate the company's key drug development timelines, identify dependencies and risks of key milestones, and assist with identifying options for achieving specified timelines. This person will be a key resource to the clinical development team and participate in eCTD submission planning and monitoring. . This person will report directly to the Chief Medical Officer.

This is a newly created position based on growth

PRIMARY RESPONSIBILITIES:

  • Work with all Clinical study teams to identify and track timelines for key deliverables through Clinical Study Report for each clinical trial

  • Identify and track detailed timelines for planned New Drug Application (NDA) submissions and amendments

  • Identify and track top-line timelines for other planned submissions to regulatory authorities

  • Identify dependencies among key milestones and deliverables and assist staff in identifying options to achieve milestones on time

  • Develop and track other timelines as needed by either the Chief Medical Officer or VP

Skills/Requirements

SKILLS & REQUIREMENTS:

  • BS Degree

  • 5 + years experience in drug development

  • Experience as a Clinical Project Manager including regulatory document filing supporting CMC teams.

  • An understanding of the overall drug development process and knowledge of regulatory requirements specific to the US and EU, based on hands-on experience

  • Relevant experience in Clinical Development project management, including experience with NDA submissions

  • Ability to use verbal and written communication and negotiation and interpersonal skills to achieve understanding and accurate updates of timelines from across the company

Corbus Culture:

Corbus is a close-knit team of over 100 employees who are high-achievers, innovative, creative and, above all else, passionate about what we do. We hire for personality as well as for skill.

You must thrive in an entrepreneurial and autonomous environment where you will succeed based on your contribution and work ethic, not on your title or rank. At Corbus we take pride in our "family" atmosphere where each person's contribution is vital to our success. As a Corbus employee, you are empowered to think creatively and be proactive in your approach. There is no place for politics or red tape here. Positive, team-oriented people work at Corbus and are rewarded with fun perks like weekly food deliveries to our kitchen, a monthly in-house massage therapist, company-paid classes with Title Boxing, and organized company activities and outings. Additionally, Corbus offers an attractive, comprehensive benefits package.

About Corbus:

Corbus Pharmaceuticals Holdings, Inc. (NASDQ: CRBP) is a Phase 3 clinical-stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat inflammatory and fibrotic diseases by leveraging its industry leading pipeline of endocannabinoid system-targeting drug candidates. The Company's lead product candidate, Lenabasum, is a novel, synthetic, oral, selective cannabinoid receptor type 2 (CB2) agonist designed to resolve chronic inflammation and fibrotic processes. Lenabasum is currently being evaluated in systemic sclerosis, cystic fibrosis, dermatomyositis, and systemic lupus erythematosus.

Corbus licensed the exclusive worldwide rights to develop, manufacture and market drug candidates from more than 600 novel compounds targeting the endocannabinoid system from Jenrin Discovery LLC. The pipeline includes CRB-4001, a 2nd generation, peripherally-restricted, selective cannabinoid receptor type 1 (CB1) inverse agonist specifically designed to eliminate blood-brain barrier penetration and brain CB1 receptor occupancy that mediate the neuropsychiatric issues associated with first-generation CB1 inverse agonists. Potential indications for CRB-4001 include NASH, primary biliary cholangitis, idiopathic pulmonary fibrosis, radiation-induced pulmonary fibrosis, myocardial fibrosis after myocardial infarction and acute interstitial nephritis, among others. CRB-4001 is scheduled to enter a Phase 1 study in 2019 followed a National Institutes of Health (NIH)-funded first-in-patient Phase 2 study.

www.corbuspharma.com

Corbus Pharmaceuticals Holdings, Inc. is an equal opportunity employer


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Project Manager, Clinical

Corbus Pharmaceuticals Holdings, Inc.