Director, Clinical Science

Location
United States
Posted
Nov 03, 2020
Ref
487602986
Required Education
Doctorate/PHD/MD
Position Type
Full time
The Director, Clinical Science role is a position that serves as a key interface between Clinical Science and other cross-functional areas including biostatistics, clinical operations, regulatory, and medical communications to ensure alignment of medical strategy, data analyses and interpretation for inclusion in clinical trial, regulatory and peer-reviewed documents and presentations. . The ideal candidate will be highly motivated and be able to work with minimal supervision both independently and collaboratively on cross-functional teams and have demonstrated analytical skills in data handling and integration to address scientific questions. He/she must possess excellent written, communication, and problem-solving skills.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
  • Independently and/or under direction of medical directors and in collaboration with biostatistics compile data for interpretation to address scientific questions arising from clinical trial results
  • Conduct literature reviews as needed to inform scientific strategy and/or identify references to support findings
  • Content generation for documents including but not limited to study synopses, protocols, regulatory study reports, peer-reviewed abstracts/manuscripts/presentations
  • Interface with research on translational activities related to clinical study activities, such as exploratory biomarker or other exploratory investigations


KEY ACTIVITIES:
  • Ensure alignment of medical strategy, between Development TA and other cross-functional areas as indicated
  • Contribute to the design of the protocol feasibility process, synopsis and protocol development
  • Ensure consistency of study-specific plans, CRFs and other documents with the protocol and ensure that appropriate input is provided to generate desired data
  • Handle trial data output and comfort compiling and analyzing using tools such as SpotFire
  • Support the Medical Directors in the interpretation of clinical study data and the preparation of/author technical sections of clinical study reports, and regulatory submissions; ensure consistency of these documents for clinical • program
  • Organize advisory board meetings or external committee meetings
  • Represent Clinical Research by participating in cross-functional task forces/process improvement groups and recommend and implement innovative process ideas


EDUCATION/EXPERIENCE/SKILLS:

Education:
  • Doctorate degree & 4 years of directly related experience OR
  • Master's degree & 8 years of directly related experience OR
  • Doctorate can be PhD, PharmD, MD, or equivalent

Experience:
  • Nine (9) years work experience in life sciences or medically related field
  • Seven (7) or more years of clinical research experience and/or academic research experience including experience working on peer-reviewed publications
  • Previous experience in developing therapeutics for cardiovascular indications


Knowledge:
  • Demonstrated scientific contribution in relevant therapeutic or product area; proficiency understanding the clinical strategy for cardiovascular products
  • Knowledge to represent and evaluate strategies for clinical development and to critically evaluate outside expert advice
  • Experience using SpotFire or other data analytical tools
  • Extensive knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and international regulatory requirements/guidelines
  • Experience conducting clinical trials in cardiovascular disease
  • Project management/project planning experience
  • Proficiency in anticipating and resolving problems
  • Experience writing and presenting clearly on scientific and clinical issues
  • Experience leading teams in a matrix environment