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Vice President of Clinical Research

Vice President of Clinical Research

ID 
2018-1178
Category 
Clinical Development
Job Location 
US-MD-Rockville
Type 
Regular Full-Time

More information about this job

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

The VP of Clinical Research will provide medical input to all aspects of product development from preclinical research, through Phase I/II/III Clinical Trials. Will have full responsibility for the leadership, planning, implementation and daily operation of drug development projects and provide medical expertise and leadership necessary to complete clinical study programs leading to the filing of Biologics Licensing Applications (BLA) to FDA. He/she will develop a clinical development strategy, advise management, and participate in interactions with Regulatory agencies on behalf of the company. Will serve as the scientific and medical leader for clinical team(s) working closely with clinical project lead, the regulatory lead, and the operational lead(s) for overall programs and external principal investigators. Develops clinical study concepts based on thorough scientific review and consultation with internal and external experts as well as senior scientists.  This position involves both high level strategic planning as well as hands-on responsibilities.

 

Responsibilities and Job Duties:

  • Collaborate with colleagues in Clinical Development, Research, Product Development and Regulatory Affairs, external experts, and business partners in designing, implementing, conducting, and reporting of clinical trials including protocol development and the design of studies, statistical design, CRO selection and management, site monitoring, safety, and clinical support of regulatory interaction.
  • Direct and oversee the design and implementation of early stage clinical projects as a member of our Product Development Team (PDT) and leader of the Product Steering Committee (PSC). Design scientifically rigorous and maximally cost-effective clinical protocols that are aligned with the clinical development plan, are suitable to test the trial's hypothesis, and likely to meet the objectives of the trial while also ensuring study design elements that are ethical and consistent with standard of care and local practices
  • Present and defend protocols and clinical development plans at internal governance forums. 
  • Responsible for the safety monitoring of clinical trials as the medical monitor, and as medical expert for Phase I/II and III studies, managing the process from protocol development thorough individual study report and integrated regulatory documentation.
  • Interact 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.
  • Direct protocol implementation, including site identification and communication, attend investigators’ meetings, correspond with sites including IRBs, and interact with operations teams.
  • Present study updates, interim results, and final headline data to senior management as required.
  • Establish and maintain strong communications with prominent clinical investigators in his/her particular field of expertise to continue learning about best practices and to build relationships for future studies
  • Support data analysis and assembly, including clinical study report writing, contribution to the preparation of abstracts, presentations, and manuscripts.
  • Serves as the clinical/medical team expert to provide direction to all project team functions, organizes Advisory Board meetings (e.g., agenda setting), steering committees and data safety monitoring boards as required. and identifies and liaises with KOL regarding program strategy and scientific advice 
  • Act as primary developer of clinical/scientific content for communications with regulatory agencies and IRBs/ethics boards.
  • Serve 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.
  • Directly develop or guide the development of scientific/medical portions of clinical study reports, safety reports, and regulatory submissions to assure production of high quality documents.
  • Review potential in-licensing candidates and present recommendations to Senior Management groups. Support any needed due diligence and prepare/present medically sound strategy and plans associated with advanced opportunities.
  • Contribute and support department and clinical initiatives to improve the quality and content of all clinical programs as well as the cross functional/organization processes designed to effectively deliver our R&D portfolio.
  • Oversee, mentor and provide leadership to subordinates and colleagues involved in clinical trial execution

Qualifications

Education & Credentials

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

 

Experience

  • 10 years of professional level experience in clinical research in academia or industry
  • Minimum of 7 years of clinical research experience (phases I-III) in oncology
  • Prior experience in late stage clinical trials focused on immune-oncology and antibody based product candidates
  • Possesses both early and late phase clinical development experience in biologics
  • Prior clinical development experience in the pharmaceutical/biotechnology industry setting required
  • Prior experience supervising, mentoring, coaching and leading other physicians in clinical research

  

Knowledge, Skills and Abilities

  •  Strategic thinker who can provide vision and purpose for teams
  • Demonstrates managerial courage
  • Well-regarded for intellectual strength and achievement as a clinical scientist
  • Excellent working knowledge of drug development process
  • Ability to successfully lead collaborative teams and drive for results
  • Strong strategic and analytical abilities
  • Ability to make sound and timely decisions
  • Effective influence and relationship management skills with internal and external partners. 
  • Able to set priorities for team, establish clear direction and objectives and maintain accountability
  • Able to balance scientific & business perspectives
  • Demonstrated success in fostering an environment that brings out the best in people
  • The ability to communicate both orally and in writing to a high standard, and handle group and individual presentations effectively
  • Must have strong conceptual abilities and analytical skills
  • Strong understanding of principles of GCP, ICH and CFR. 
  • Working understanding of statistical principles and guidelines as these apply to clinical trials

 

Supervisory Responsibilities:  

TBD

 

Preferred Qualifications

Clinical experience and academic track record in solid tumors or hematologic malignancies is preferred 

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.

Equal Opportunity Employer/Veterans/Disabled

 

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