Senior Medical Director Clinical Research – Hepatology

Job Description

Job Summary:

• Client Pharmaceuticals is seeking an imaginative physician drug developer.
• This is an opportunity to provide clinical leadership in developing RNAi therapeutics in client rapidly expanding portfolio, which spans the areas of rare genetic diseases, cardio-metabolic diseases, neuroscience, hematology and hepatology.
• The successful candidate’s primary role will be to drive the pipeline forward through leadership of clinical development programs.
• While the primary focus responsibility will be as clinical lead physician on client autoimmune liver disease programs, the role may support across a range of therapeutic areas and all stages of development may be required as pipeline assets evolve.
• The Sr. Director is expected to play a leading and influencing role in the overall clinical development strategies and drive progress and operational excellence for associated clinical trials.
• In addition, this role will include interaction with Client’s research group, helping to advise the team on the clinical development feasibility of Client targets and the design of proof-of-concept studies.
• This work will also involve extensive consultation and collaboration with external experts.
• It is expected that additional opportunities will arise to lead bench-to-bedside early phase clinical development programs.
• The Senior Director, Clinical Research, will work in a matrix organization across Regulatory, Biostatistics, Clinical Operations, Preclinical, Commercial & QA teams to ensure fully harmonized and integrated development strategies.
• They will be a key client Development spokesperson at external meetings, including regulatory interactions and scientific meetings.
• This position is hybrid and will be primarily located at our Cambridge, MA headquarters or Maidenhead, UK location.

Duties and Responsibilities:

• Be the strategic leader providing a strong, clear voice for the clinical programs.
• Develop creative but realistic approaches to drug development and lead clinical efforts to secure global regulatory approvals.
• Oversight of trial conduct and safety.
• Provide strategic consultation and guidance to Research on all decisions that have significant clinical components and implications.
• Collaborate closely with Preclinical, Regulatory Affairs, Medical Affairs and Commercial to ensure tight strategic integration of product development plans.
• Be accountable via Clinical Research and Operations for all relevant timelines and deliverables.
• Drive/supervise all major written deliverables (regulatory submissions, original articles, abstracts), and presentation materials.
• Be responsible (as appropriate in line with SOPs) for final review and sign off with respect to all controlled documents including protocols, IBs, informed consent forms.
• Influence internal and external audiences in a high impact, highly visible fashion.

Qualifications:

• MD with strong research background or MD PhD, with a track record of successful research support and peer review publications.
• Board Certification (or equivalent) or specialist training is highly desirable; drug development experience in hepatology (autoimmune liver disease) would be a great advantage, but not essential
• 10+ years industry experience or equivalent clinical academic experience.
• Sound scientific and clinical judgment.
• Successful track record of leading Phase 2/3 clinical programs, including major interactions with Health Authorities.
• Familiarity with concepts of clinical research and clinical trial design, including biostatistics, regulatory agency organization, guidelines, and practices.
• Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication.
• History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues.
• Outstanding leadership and collaboration skills working within a matrix environment.
• Experience and knowledge of working with biotech/pharma partner(s) a plus.
• Thrives in highly entrepreneurial biotech environment and embraces Client’s culture of science, passion and urgency.