Clinical Research Physician

US-MD-Rockville
Requisition Number
17-920
Category
Clinical Development
Type
Regular Full-Time

Overview

MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies.  Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various autoimmune disorders and infectious diseases.  Our products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.

 

The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.

Summary of Position

This Clinical Research Physician will provide medical input to all aspects of product development, for new and innovative treatments being developed in patients.  Will serve as scientific and medical member for clinical team(s) working closely with clinical project lead, the regulatory lead, and the operational lead(s) for overall programs within the therapeutic area. Develops clinical study concepts based on thorough scientific review and consultation with internal and external experts as well as senior scientists.  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 and operations, research, bioPharma development and manufacturing, regulatory affairs, and product safety to participate in protocol development and the design of studies, statistical design, CRO selection and management, site monitoring, safety, clinical support of regulatory interaction, study reporting for new products that will ensure regulatory approval and commercial success.
  • Ensures that study design is scientifically robust, suitable to test the trial's hypothesis, and likely to meet the objectives of the study while ensuring the safety of the patients participating in the Company’s sponsored clinical trials.
  • Interacts closely with the pre-clinical team, to understand the scientific basis of targeted therapy, and to apply this knowledge to articulating therapeutic strategies and comprehending biomarker exploration and provides clinical and medical perspective to preclinical development programs.
  • Handles medical components of the design, execution, and reporting of study protocols as well as (in collaboration with other team members) labeling and regulatory communications under the direction of the clinical leader or delegate.
  • Directly develops or 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, including site identification and communication, attend investigators’ meetings, correspond with sites including IRBs, and interact with operations teams.
  • Supports data analysis and assembly, including clinical study report writing, contribution to the preparation of abstracts, presentations, and manuscripts.
  • Organizes clinical advisory boards, steering committees and data safety monitoring boards as required.
  • 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.
  • Establishes and maintains 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 an information resource to the Company with regard to the science of the field, the competitive landscape in research, and the current state of treatment in areas of unmet medical need.
  • Oversees and 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.

Qualifications

Education & Credentials

M.D. with subspecialty board eligibility/certification in oncology

 

Experience - Associate Director level

  • Minimum of 2 years of successful clinical research experience
  • Experience in oncology clinical research
  • Combination of early and late phase clinical development experience

Experience - Director level

  • Minimum of 3 years of successful clinical research and/or drug development experience in biologics
  • Experience in oncology clinical research
  • Combination of early and late phase clinical development experience
  • Prior clinical development experience for/in the pharmaceutical/biotechnology industry setting

Knowledge, Skills & Abilities

  • Strong collaborative skills and track record of working effectively within the team setting
  • Understanding of the unique product safety, clinical development and regulatory requirements of biological products
  • Well-regarded for intellectual strength and achievement as a clinical scientist
  • Superior leadership skills
  • Effective influence and relationship management skills with internal and external partners 
  • Demonstrated ability to think creatively and strategically
  • Excellent written and oral communication skills demonstrating ability to organize, interpret and communicate complex information effectively and succinctly including formal and informal presentations
  • Strong understanding of principles of GCP, ICH and CFR
  • Strong analytical and problem solving skills 
  • Working understanding of statistical principles and guidelines as these apply to clinical trials

Supervisory Responsibilities:

None at this time

 

Statement

MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service.

For more information about our commitment to equal employment opportunity, please click here.

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