Senior Medical Director-Clinical Development

  • Full-time

Company Description

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

Job Description

Job Description

The Sr. Medical Director will lead and help take ownership of one or more of our progressing clinical trials while providing strategic direction, leadership and medical expertise to our growing clinical development team. This role provides the opportunity for the right candidate with superior protocol writing, medical monitoring and KOL interaction skills and experience with the opportunity to truly make an impact on the lives of patients and future success at Corbus.

PRIMARY 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)

 

 

 

Qualifications

SKILLS & REQUIREMENTS:

· Medical Degree with active U.S. medical license

· 3 + years experience in medical monitoring/drug safety PVG in a drug development organization (biotech, pharma, CRO) for Senior Medical Director

· 3 years + of clinical research experience via academia for the Medical Director role

· Through understanding of the benefit/risk management implications of drug development

· 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

Additional Information

All your information will be kept confidential according to EEO guidelines.