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Senior Medical Director (Oncology)

Company

Corbus Pharmaceuticals

Address Norwood, MA, United States
Employment type FULL_TIME
Salary
Category Biotechnology Research,Pharmaceutical Manufacturing
Expires 2023-08-01
Posted at 10 months ago
Job Description

At Corbus we are committed to connecting innovation to purpose. We are bringing new insights to the fields of biology, with the aim of improving outcomes for cancer patients. We are committed to the concept of precision medicine, even in the field of immune oncology. Taking advantage of the evolution of multi-omic platforms to create deeper resolution as to the mechanism of action of our emerging medicines. We are creating a complementary pipeline balanced for both risk and speed.


We are seeking an experienced and highly motivated physician to join our team in Norwood, Massachusetts to support our expanding pipeline. This role would be responsible for clinical research activities to advance the development of our clinical portfolio. This physician will have primary responsibility for the design and medical implementation of key clinical development programs for the company. The position has high visibility and will interact across the organization. This leader will also have a pivotal role in managing effective relationships with Key Opinion Leaders and stakeholders both internal and external to the company.



Responsibilities:



  • Collaborate with Clinical Operations to execute clinical trials from beginning to end, overseeing study conduct and interpreting the study results. consistent with objectives to define safety, efficacy, pharmacokinetic/pharmacodynamic, patient reported outcomes, and application of data to a targeted patient population.
  • Develop and maintain strong, collaborative relationships with key internal and external stakeholders, including developing and moderating advisory boards, Independent Data Monitoring Committees (IDMCs) drug safety monitoring boards (DSMBs)
  • Network extensively to develop long-term strategic partnerships with thought leaders both internally and externally, in support of the Corbus vision.
  • Act as Medical Lead on one or more clinical studies, overseeing medical monitoring activities such as assessing patient eligibility, medical review of Serious Adverse Events and lead the Product Safety Sub-Team.
  • Provide input into and reviews other relevant study documents including but not limited to, the informed consent (ICF), protocol deviation management plan (PDMP), study reference manual (SRM)
  • Lead Product Development Teams (PDTS) and contribute to the development of an asset strategy / clinical development plan involving the creation of a successful lifecycle management strategy sensitive to global considerations and operational decisions. Collaborate with physicians, scientists, regulatory professionals, biostatisticians, regulatory, executive staff and others as necessary to validate and design clinical development plans including individual clinical trial protocols.
  • Act as primary medical contact for study physicians and sites engaging during study feasibility through close-out.
  • Interpret clinical study and safety data to drive/contribute to clinical study reports (CSRs), clinical components of the IB, and documents for regulatory submissions and advisory requirement, including Scientific Advice, Pediatric Investigation Plans, INDs, EoP2, pre-NDA/BLA meetings, NDA/BLA and MAA documents.
  • Collaborate with Principal Investigators in the evaluation and assessment of publications (abstracts, posters, manuscripts) associated with clinical data.
  • Provide strategic medical input into development of the company’s key assets identifying relevant target patient populations.
  • Act as subject matter expert on clinical and medical strategic initiatives and provide internal training/ collaboration as needed.



Required Skills/Experiences:



  • Desirable to have clinical experience in the implementation and development of companion diagnostics.
  • Demonstrated ability to function in a matrix organizational environment.
  • Solid personal and professional relationships with key opinion leaders (KOLs) in the oncology therapeutic community. Strong credibility within the broader US/European medical community which includes the ability to reach out to key thought leaders in academia.
  • US State Licensure to practice medicine is desirable.
  • MD (or equivalent) with board certification or board qualifications in medical or pediatric or radiation oncology.
  • Minimum of 3 years drug development experience in Pharma, Biotech or CRO in Oncology drug development supporting studies to develop new biological therapeutics.
  • Successful academic research publication history or history of medical practice.
  • 10+ years of relevant experience, including medical training and clinic experience.
  • Strong working knowledge of the clinical drug development process. Track record in the conduct/participation in clinical trials (investigator initiated, company sponsored or cooperative group trials) and their subsequent publications.
  • Ability to travel as necessary (up to 20%)



Corbus Culture:



Our passion. Our purpose. At Corbus, it starts at our core.

We look for unique talent. Our people are brilliant, they break barriers and are not defined by a title. Eclectic experiences make Corbus a special place to share ideas and grow. At Corbus, transformative ideas can come from anyone, anywhere and anytime. We offer our team flexibility and the opportunity to excel in their professional journey. We provide a welcoming space where collaboration, mentorship and diversity are encouraged. We come together, like no other, to elevate each other and focus on what’s best for patients.



About Corbus



Corbus is committed to leveraging our expertise in immunology to fulfill our purpose of developing innovative new medicines that improve the lives of people living with inflammatory, fibrotic, and metabolic diseases, and cancer. Corbus’ current pipeline includes small molecules that activate or inhibit the endocannabinoid system and anti-integrin monoclonal antibodies that block activation of TGFβ. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com. Connect with us on Twitter, LinkedIn and Facebook.



Corbus Pharmaceuticals Holdings, Inc. is an equal opportunity employer