(Sr.) Medical Director, GI

 

Our client, a Top 20 Pharma has exclusively engaged Junto HLS to recruit an (Sr.) Medical Director, GI to establish strategy, make high impact decisions and lead a cross-functional, global matrix team for a novel MAb in UC/Crohn’s.

Select Accountabilities:  

  • Establishes and drives Development Team strategy and deliverables producing the Development Strategy, Clinical Development Plan and Clinical Protocols.
  • Leads a multi-disciplinary, multi-regional, matrix team.
  • Responsible for high impact global decisions: monitoring and interpreting data from ongoing internal and external studies, assessing the medical and scientific implications, and making recommendations that impact regional and global development such as “go/no go” decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling.
  • Drives clinical science activities relating to the preparation / approval of synopses, protocols and the conduct of clinical studies. Serves as an advisor to other clinical scientists involved in these activities, and is accountable for the successful design and interpretation of clinical studies.
  • Directs activities involved in interactions with regulatory authorities / agencies and clinical development activities undertaken to establish and maintain strong relationships with key opinion leaders relevant to assigned compounds and therapeutic areas.
  • Responsible for identification and evaluation of potential business development opportunities, conduct due diligence evaluations, and development and negotiation of clinical development plans for potential alliances and or in-licensing opportunities.

Education and Experience:

  • MD or internationally recognized equivalent plus 5 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned).
  • Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions.
  • NDA/MAA/Submission experience preferred.
  • Management experience

Skills: 

  • Superior communication, strategic, interpersonal and negotiating skills
  • Ability to proactively predict issues and solve problems
  • Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams
  • Diplomacy and positive influencing abilities

Knowledge:

  • Therapeutic area knowledge relevant to mechanism of action
  • Regional/global Regulatory requirements
  • GCP/ICH
  • Emerging research in designated therapeutic area

Location(s):

  • Greater Boston, MA

If you are open to explore and learn more about this opportunity submit your resume using the button below or send directly to DanFarina@JuntoHLS.com.