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Clinical Scientist - Associate Director/Director

Workforce Genetics Rockville, MD, USA

Workforce Genetics is recruiting a Clinical Scientist, Associate Director/Director for a clinical-stage biopharmaceutical company in Maryland. Our client's pipeline is strategically positioned to address key unmet needs in immuno-oncology and infectious disease. The Clinical Scientist will report to the Vice President of Clinical Development and will work cross-functionally with R&D, Translational Sciences, Clinical Operations, and the Executive leadership team.

RESPONSIBILITIES

  • Works closely with Clinical Project Managers (CPMs) and lead, with hands-on approach, the development of synopses, protocols and protocol amendments.
  • Contributes to and collaborates with Clinical Project Managers with regards to ongoing or planned clinical trials as needed.
  • Assists the HCD in preparing and/or reviewing clinical portions of regulatory documents, such as INDs, BLAs, IB updates, drug safety update reports, clinical study reports, medical reports, efficacy and safety summaries, and developing areas for medical and scientific information to support the rationale for study design and interpretation clinical data
  • Establishes and maintains relationships with alliance partners, external companies (such as CRO), investigators, and Key Opinion Leaders to optimize performance on clinical trial activities.
  • Prepares and/or reviews abstract/manuscripts/presentations for technical journals and scientific meetings.
  • Works collaboratively with Research and Development to lead PK/PD/biomarker's analysis plan for ongoing clinical trials.
  • Develops effective communications internally and externally.
  • Assists the HCD in pharmacovigilance for clinical projects including detecting safety signal and providing scientific support in reviewing and reporting of AEs/SAEs and evaluating benefit/risk assessments.
  • Other tasks assigned by Chief Executive Officer (CEO) or Chief Medical Officer (CMO)

REQUIREMENTS/QUALIFICATIONS:

  • Exemplify guiding principles of building strong teams, leading with inspiration, making data-driven decisions, and maintaining focus.
  • Critical, creative, and deep thinker.
  • Demonstrated ability to think strategically and successfully operationalize ideas and visions.
  • Ability to work accurately with close attention to detail.
  • Excellent written and verbal communication skills.
  • High level of personal integrity, high moral character, excellent work ethics, and respect for colleagues at all levels.
  • Excellent manager with a desire to help with the career development of individuals on cross-functional teams.
  • Demonstrated knowledge of FDA/EMEA requirements, good clinical practices, and pharmaceutical clinical development in oncology.
  • Ability to build solid relationships with the NCI, NIH, and other agencies including European collaborative groups, and to forge strong internal and external partnerships.
  • Proven organizational and project management skills and ability to handle multiple diverse projects simultaneously.
  • Ability to maintain a problem-solving attitude in response to time demands and unexpected events.
  • Capable of supporting multiple projects simultaneously.
  • Ability to succeed in a deadline-driven environment with a “can-do” attitude.
  • Ability to travel domestically and internationally (~ 10% or less, not applicable during COVID-19 pandemic).

Education/Experience:

  • Ph.D., PharmD, or MD required.
  • Oncology, Immunology, Infectious Disease experience preferred.
  • Minimum of 5 years relevant experience in biotech of pharmaceutical industry.
  • Supervisory experience preferred.

Posted date: 17 days ago

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