Medical Director

Seuss+

Medical Director - Clinical Development Department

Introduction
  
Our client is a dedicated and revolutionary Biotechnology company currently in the process of developing a pipeline of Gene- Therapy products to target serious orphan diseases. Established in 2016, this company has seen significant growth and secured significant funding along with the first approval to begin Phase I of clinical studies.
  
Position
  
This growing Biotechnology company is looking to appoint a Medical Directors to provide comprehensive medical input to the company’s ongoing portfolio, around developing new treatments for patients affected by serious orphan diseases. This role is within the clinical development department, reporting directly to the CMO.

Responsibilities and Duties
  • Collaborate cross-functionally in the preparation of clinical development plans, protocols, investigator brochures, annual IND reports, clinical study reports, manuscripts, and different scientific presentations.
  • Act as a medical resource to the clinical study teams.
  • Participate in clinical team meetings.
  • Participate in Development Team Meetings
  • Handle day to day clinical, medical, scientific questions from internal and external sources
  • Train study teams on disease states, treatments, protocol compliance, inclusion and exclusion criteria, procedures, and assessments.
  • Review and approve coding in clinical trials.
  • Identify program risks, and create and implement mitigation strategies.
  • Contribute to the analysis of clinical data including safety monitoring in collaboration with the pharmacovigilance expert.
  • Review clinical documents with respect to medical relevance.
  • Maintain clinical knowledge and collaborate with external experts on protocol development, Scientific AdBoards etc
  • Oversight of potential vendors depending on the outsourcing model
  Requirements
  • Medical education (MD)
  • Strong scientific, medical and regulatory expertise knowledge and experience in the various (rare) disease and indication areas
  • 5+ years of experience in the biopharmaceutical industry
  • Strong hands-on experience with clinical study management and conduct
  • Excellent working knowledge of applicable global, regional, local clinical research regulatory requirements; i.e. Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines, SOPs.
  • Proven ability to meet strict deadlines; manage competing priorities and changing demands, Sound organization, and time management skills.
  • Ability to follow instructions/guidelines, work independently, and on own initiative.
  • Good attention to detail and accuracy and maintain high-quality standards.
  • Excellent IT skills.
  • Fluency in English, and effective written and verbal communication skills.
  • Ability to be flexible and receptive to changing process demands.
  • Willingness and aptitude to learn new skills across service lines.
  • Ability to establish and maintain effective working relationships with co-workers, managers, and clients.
  Core competencies
  • Self-motivated and able to work with limited supervision
  • Should be willing to support all other functions which require his/her input
  • Should pro-actively think about who else needs information from his/her work results
  • Planning and organizing
  • Able to create buy-in from functional groups and departments
  • Cost-conscious
  • Embraces change, welcomes diversity and can support others to move through change
If this position is of interest and you would like to learn more about the role please get in touch with Syeda Islam via email s.islam@consultseuss.com or +447552024601, Thank You!