Corbus Pharmaceuticals
Corbus Pharmaceuticals Holdings, Inc. is a clinical-stage company focused on the development and commercialization of novel medicines designed to target the endocannabinoid system. The Company’s lead product candidate, lenabasum, is a novel, oral, selective cannabinoid receptor type 2 (CB2) agonist that resolves chronic inflammation and limits fibrosis in animal and human models. Lenabasum is currently being evaluated in dermatomyositis and systemic lupus erythematosus. Corbus is also developing a pipeline of other preclinical drug candidates from its endocannabinoid system platform.
Corbus Pharmaceuticals is hiring a Remote Senior Director/Director, Global Regulatory Affairs
Job Description
General Description:
As a pivotal member of the Corbus Product Development Team(s) (PDT) supports Corbus’ drug development by developing and overseeing the execution of regulatory strategy in the US/EU and other territories deemed applicable.
Responsibilities:
- Collaborate with the leadership team to develop Regulatory Strategy as part of an integrated development plan for each Corbus asset including inclusion/adoption of accelerated regulatory pathways where possible.
- Proactively identifying regulatory risks and working with the Corbus Product Development Team to mitigate those risks.
- Leading working groups tasked with developing regulatory submissions e.g. IND working group.
- Overseeing clinical trials submissions performed by Contract Research Organizations (CRO) ensure timely and good quality submissions supportive of the overall
- Providing regulatory input on safety documentation e.g. Development Safety Update Report (DSUR), Investigator’s Brochure (IBs)
- Providing regulatory input on clinical documentation as required e.g. Protocols, Clinical Study Reports (CSR)
- Reviewing external communications e.g. Publications, Press Releases, Clinicaltrial.gov postings for regulatory compliance
- Identifying and managing subject matter experts engaged to support regulatory activities
- Ensuring that Corbus has a complete record of all regulatory submissions made by the company or on behalf of the company.
Qualifications
Qualifications and Experience:
- Bachelor’s Degree in life sciences
- Higher degree preferred or equivalent experience
- 15+ years’ experience in biotech or pharma with 10+ years in Regulatory Affairs
- Experience in all types of regulatory submissions including but not limited to INDs, NDAs, MAA, Type A-D Meetings with FDA, Scientific Advice Consultations with the CHMP of EMA and MHRA, MAA.
- Experience with filing Orphan Drug Designations (ODD), FastTrack, Breakthrough Designations (BTD) and Priority Medicines Initiatives (PRIME) and other accelerated regulatory pathways ideal.
- Ideally this role will be located in Norwood, Massachusetts as a hybrid role 3 days onsite weekly but flexible for remote candidates open to travel monthly to Norwood, Massachusetts.
Qualities:
- Demonstrate a collaborative leadership style within the Product Development Team when providing regulatory expertise.
- Prepared to be hands-on as well thinking strategically.
- Communicate well with internal and external stakeholders.
- Be able to effectively articulate to Senior Management regulatory risk and the potential impact.
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Corbus Pharmaceuticals is hiring a Remote Director/Associate Director, Clinical Scientist
Job Description
Job Description:
This role reports through the Clinical function which provides scientific expertise necessary to design, implement and interpret data from clinical studies. The role provides scientific input and oversight, as well as leadership and management of cross-functional execution of clinical studies in collaboration with Clinical Operations. This role will be responsible for the scientific aspects global clinical trial delivery including protocol design and writing, analysis of data, management and reporting of trials in accordance with company plans/objectives, ICH-GCP, country requirements and company standard operating procedures. Specifically, this includes writing and/or reviewing protocols, interacting with sites for feasibility assessment, supporting site selection, data review and writing/reviewing the clinical study report, for one or more clinical trials. Other important tasks will be supporting the Chief Medical Officer and Head of Operations planning, publication strategy and other tasks.
Ideally this role will be located in Norwood, Massachusetts as a hybrid role 3 days onsite weekly but flexible for remote candidates open to travel monthly to Norwood, Massachusetts.
Key Responsibilities:
- Lead the clinical study protocol development process by translating the strategy and approved concept into executable, efficient clinical protocols and related documents.
- Maintain current knowledge of the external environment to ensure scientific innovations are considered and/or incorporated into clinical trial development strategy.
- Support study design, translate scientific imperative into operational delivery of trials. Review and/or writing of study concept, protocol, statistical analysis plans, study plans, CSRs.
- Evaluate innovative trial designs in collaboration with Head of Operations and Chief Medical Officer
- In collaboration with internal/external experts on biostatistics, clinical pharmacology, translational medicine, clinical operations and data management, contributes to the development of the plans to execute on trial design including CRF design, data review plan, statistical analysis plan review and finalization.
- Co-lead the cross-functional clinical trial working groups, collaborating with Clinical Operations and extern functions to drive delivery and facilitate issue resolution.
- Collaborate with Clinical Operations to plan and/or conduct site evaluation and initiation; develop and maintain effective relationships with clinical sites globally.
- Collaborate with other Corbus functions to support effective study specific vendor interactions
- Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team members
- Drive the review, analysis, and interpretation of study results ensuring that accurate conclusions are drawn and working with our CMO to appropriately contextualize
- Identify study and program-wide issues by reviewing and monitoring of emerging clinical data related to safety, efficacy and PK/PD. Develops sound, strategic solutions to issues and collaborates with the clinical study team to ensure issue resolution.
- Conduct literature reviews as needed for the interpretation of study data and development of next steps.
- Works closely with the CMO to ensure they are informed of pertinent study information, including but not limited to safety and efficacy data.
- Support the development of program documents, including the clinical sections of various regulatory documents such as IND, clinical study reports, investigator brochures, annual reports (DSURs) and periodic updates, and clinical sections of regulatory submissions to support product approvals.
- Support the implementation of target/pathway engagement assays for selecting therapeutically relevant doses and schedules, support stratification biomarkers.
- In conjunction with the CMO, develop presentations and communicate study data results to colleagues internally and to external audiences including investigators at sponsor meetings or general audiences at scientific conferences.
Qualifications
Qualifications & Experience:
- Minimum of a BA/BS in Life Sciences Degree with 7+ years of experience or an advanced clinical/science degree e.g. MA + 5 years of clinical or PharmD/PhD +3 years.
- Significant experience working in early phase oncology is required to ensure proficiency in knowledge of the disease area(s), KOLs, indication(s), compound(s) under study (including MOA, PK/PD, biomarker & safety profile)
- A thorough understanding of the drug development process from pre-IND through registration and post-registration and a broad understanding of functional areas of drug development, including (preclinical, regulatory, pharmacology, translational medicine, pharmacovigilance, data sciences (data management, biostatistics, programming), and clinical operations is require
- Strong verbal and written communications skills, including an understanding of medical and scientific terminology and the ability to summarize information effectively
- An ability to work collaboratively with team members and stakeholders from different functions.
- Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review or similar data reporting tools
- Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism.
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Corbus Pharmaceuticals is hiring a Remote Head, Global Regulatory Affairs
Job Description
General Description:
As a pivotal member of the Corbus Product Development Team(s) (PDT) supports Corbus’ drug development by developing and overseeing the execution of regulatory strategy in the US/EU and other territories deemed applicable. This role will be either at Senior Director/Director level.
Responsibilities:
- Collaborate with the leadership team to develop Regulatory Strategy as part of an integrated development plan for each Corbus asset including inclusion/adoption of accelerated regulatory pathways where possible.
- Proactively identifying regulatory risks and working with the Corbus Product Development Team to mitigate those risks.
- Leading working groups tasked with developing regulatory submissions e.g. IND working group.
- Overseeing clinical trials submissions performed by Contract Research Organizations (CRO) ensure timely and good quality submissions supportive of the overall
- Providing regulatory input on safety documentation e.g. Development Safety Update Report (DSUR), Investigator’s Brochure (IBs)
- Providing regulatory input on clinical documentation as required e.g. Protocols, Clinical Study Reports (CSR)
- Reviewing external communications e.g. Publications, Press Releases, Clinicaltrial.gov postings for regulatory compliance
- Identifying and managing subject matter experts engaged to support regulatory activities
- Ensuring that Corbus has a complete record of all regulatory submissions made by the company or on behalf of the company.
Qualifications
Qualifications and Experience:
- Bachelor’s Degree in life sciences
- Higher degree preferred or equivalent experience
- 15+ years’ experience in biotech or pharma with 10+ years in Regulatory Affairs
- Experience in all types of regulatory submissions including but not limited to INDs, NDAs, MAA, Type A-D Meetings with FDA, Scientific Advice Consultations with the CHMP of EMA and MHRA, MAA.
- Experience with filing Orphan Drug Designations (ODD), FastTrack, Breakthrough Designations (BTD) and Priority Medicines Initiatives (PRIME) and other accelerated regulatory pathways ideal.
- Ideally this role will be located in Norwood, Massachusetts as a hybrid role 3 days onsite weekly but flexible for remote candidates open to travel monthly to Norwood, Massachusetts.
Qualities:
- Demonstrate a collaborative leadership style within the Product Development Team when providing regulatory expertise.
- Prepared to be hands-on as well thinking strategically.
- Communicate well with internal and external stakeholders.
- Be able to effectively articulate to Senior Management regulatory risk and the potential impact.
See more jobs at Corbus Pharmaceuticals