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Clinical Development Medical Director (CDMD)

East Hanover, NJ 07936

Posted: 05/02/2023 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 562972-1 Is job remote?: No Country: United States

Job Description


SUMMARY:

The Clinical Development Medical Director (CDMD) is responsible for leading the strategic planning and management of the assigned clinical program(s) from an end-to-end clinical development perspective. As CDMD, you will have oversight of the clinical development for the assigned programs and drive execution of the clinical development plan. In addition, you will enable an empowered organization, which can navigate in a matrix environment and adjust quickly to business needs. Your responsibilities will include, but are not limited to:
  • Providing clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program
  • Leading development of clinical sections of trial and program level regulatory documents
  • Driving execution of the assigned clinical program and/or clinical trial in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates, where applicable
  • Supporting (Senior) Global Program Clinical Head (GPCH) in ensuring overall safety of the molecule for the assigned section, and may act as a core member of the Safety Management Team (SMT), supporting overall program safety reporting in collaboration with Patient Safety colleagues
  • Supporting the Clinical Development Head (CDH) by providing medical input into Clinical Development Plan (CDP), Integrated Development Plan (IDP) and Clinical Trial Protocol (CTP) reviews, and contributing to/driving development of disease clinical standards for new disease areas
  • As a medical expert, supporting the (Sr.) GPCH or CDH in interactions with external and internal stakeholders and decision boards
  • May work with NIBR (Institute of Biomedical Research/ Translational Medical Sciences) to drive transition of pre-PoC (Proof of Concept) projects to DDP (Development Decision Point) and with BD&L (Business Development & Licensing) including target identification and due diligences together with other medical matters, as needed.

What you bring to the role:
  • MD or equivalent medical degree is required in addition to advanced knowledge and clinical training in medical/scientific area; Clinical practice experience 4 years (including residency) and board certification or eligibility in oncology or hematology preferred
  • Minimum of 7 years of experience in clinical research or drug development
  • Experience in an academic clinical research or industry environment spanning clinical activities in Phases I through IV required. * 2 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry required.
  • Working knowledge of disease area is required, with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) and proven ability to understand and interpret basic and clinical scientific research reports
  • Demonstrated ability to establish effective scientific partnerships with key stakeholders
  • Seeking candidates with Nephrology specialty experience
  • Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes
  • Previous global people management experience is preferred, though this may include management in a matrix environment.
Pay Range - $150-$300 based on experience

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About East Hanover, NJ

Explore exciting job opportunities in the vibrant area of East Hanover, New Jersey! Nestled in the heart of Morris County, this charming town offers a perfect blend of suburban comfort and urban convenience, making it an ideal location for career growth and success. With easy access to New York City and a plethora of dining options ranging from classic Italian fare at Patsy's Tavern, to modern fusion cuisine at The Hanover Manor, East Hanover boasts a diverse culinary scene. Don't miss the chance to catch a show at the renowned Paper Mill Playhouse, or root for the New York Giants at the nearby MetLife Stadium. From the lush landscapes of Central Park to the rich history at the Morristown National Historical Park, there's no shortage of recreational activities to enjoy in this dynamic area. Embrace the unique culture and endless possibilities that East Hanover has to offer, and kickstart your next career adventure today!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.