2018-10-16

Director of Clinical Development Cardiology
Job Opportunity at Clinical Dynamix, Inc.

Posted on Oct 16

http://www.clinicaldynamix.com    561-732-4505

Location: Gaithersburg, MD
Job Type: Full Time
Job ID: W4163881

Director of Clinical Development Cardio

This global Pharmaceutical company is the worldwide biologics research and development leader. Here, you’ll have the opportunity to make a difference in people’s lives every day. As one of the world’s premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease.  As a Director, Clinical Development  in Gaithersburg MD or Cambridge UK, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.
We’re constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We’re pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we’re industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the organization, as together we explore synergies between small and large molecules.
We have a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.
Position Summary:
This is a unique opportunity to join  at a time of tremendous growth and acceleration in the cardiovascular biologics portfolio.  This is a fast-paced and dynamic work environment where, with increasing levels of responsibility, this individual will be responsible for medical monitoring of ongoing clinical trials, the planning and conduct of clinical trials, providing long-range clinical development planning, planning and managing of clinical research projects and clinical development programs in the field of cardiovascular and metabolism, collaborating with and providing clinical input and expertise to pre-clinical and translational sciences, and setting and achieving goals and meeting timelines in accordance with corporate goals and budgets.
The Director will serve as the project Medical Monitor while working in a cross functional environment with representatives from other involved line functions as well as Late-Stage Development.  The Director will contribute to and support Department/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.
We are seeking a well-trained clinician with strong leadership skills who is driven by science and the desire to develop novel therapies for patients with cardiovascular disease.  This individual will have the opportunity for growth and development while working in a vibrant environment and “biotech” culture.
The ideal candidate will have a clear understanding of the drug development process (especially early phase clinical trials), protocol writing & study conduct, data review and reconciliation, the principles of translational medicine, and what it takes to lead teams successfully.
Responsibilities:
Serves as medical monitor with primary responsibility for patient safety and conduct of assigned trials as well as overall data interpretation and safety surveillance. Establish and approve scientific methods for design and implementation of applicable clinical protocols, data collection systems, and final reports.  Responsible for assisting in design of clinical development plans and overall strategy for compounds, therapeutic classes of compounds or indications in light of developments in the area of clinical and pharmaceutical cardiology.  Collaborate with pre-clinical and translational sciences, and senior management in assessing requirements for emerging products. Provide leadership on cross-functional product development team(s) as experience allows. Participate in identification, selection and conduct of negotiations with clinical research centers and investigators.  Participate in the selection and management activities of CROs. Supervise project team members in planning, conducting and evaluating clinical trials. Oversee planning and management of investigator meetings, advisory boards and other scientific committees.
Requirements:
  • MD required with a current medical license preferred.
  • Medical specialty and sub-specialty training and certification (or eligibility) highly desirable in cardiology.
  • At least 2-5 years of experience in clinical research and/or cardiovascular drug development in academia / government, pharmaceutical or CRO environment.
  • Clinical or research experience (in an academic, pharmaceutical or CRO environment) related to the design and/or conduct of clinical studies in cardiology is required.
  • Cardiovascular development experience required.
  • Experience in translational science preferred.

 
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