@ MacroGenics
  • Post Date : Jan 10, 2022
  • Apply Before : Mar 10, 2022
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Job Description

Summary of Position

The Sr. Clinical Research Director/Clinical Research Director provides medical input to all aspects of product development and manages one or more products in various stages of development (Phase 1-4).  S/he serves as scientific and medical member for clinical team(s) working closely with clinical project lead, the regulatory lead, and the operational lead(s).  The primary focus is oncology indications but may also manage non-oncology products. S/he develops clinical study concepts based on thorough scientific review and consultation with internal and external experts as well as senior scientists and acts as author/developer of clinical summary and other supporting documents for regulatory submissions and for publications.

Responsibilities and Job Duties

  • Collaborates with colleagues in clinical development, clinical operations, research, data management, manufacturing, regulatory affairs, and product safety to assure effective protocol development and study design.
  • Provides technical support for site monitoring, safety reporting, and regulatory interactions in a manner consistent with Good Clinical Practice.
  • Assures the safety of the patients participating in the Company’s sponsored clinical trials by ongoing assessments of adverse events including potential causality
  • Interacts with the pre-clinical team, to understand the scientific basis of targeted therapy and the relationship to clinical practice decision-making.
  • Provides medical guidance for the design of biomarker studies and provides a medical perspective to biomarker data interpretation.
  • Collaborates with clinical pharmacologist to interpret pharmacokinetic and toxicokinetic data and the implications for clinical study design.
  • Responsible for medical components of the study design, and reporting of study protocols as well as (in collaboration with other team members) labeling and regulatory communications.
  • Directly develops and guides development of scientific/medical portions of clinical study reports, safety reports, and regulatory submissions to assure production of high-quality documents.
  • Directs protocol implementation through communication with site investigators and their staff. Leads site initiation meetings and follow-up meetings with investigators.
  • Is a major contributor to the preparation of abstracts, presentations, and manuscripts
  • Organizes clinical advisory boards, and steering committees in collaboration with Medical Affairs where needed.
  • Provides expert evaluation of Investigator initiated proposals in support of Medical Affairs
  • Acts as primary developer of clinical/scientific content for communications with regulatory agencies and IRBs/ethics boards.
  • Ensures the feasibility of the study by incorporating study design elements that are ethical and consistent with standard of care and local practices as applicable.
  • Responsible for establishing and maintaining communications with prominent clinical investigators in his/her particular field of expertise.
  • Works with international colleagues and with external Alliance partners on research initiatives and regulatory issues.
  • Serves as a technical resource to the Company regarding topics related to mechanism of action and competing products, and the current state of treatment in areas of commercial interest.
  • Provides leadership to colleagues involved in clinical trial execution
  • Ensures consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations, and laws.
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