Senior Clinical Research Director, I&I

Role Summary

Senior Clinical Research Director, I&I based in Cambridge, MA or Morristown, NJ. The role mentors CRDs and Clinical Scientists on project teams, provides medical input for clinical studies and submission dossiers, and collaborates with cross-functional teams to ensure an aligned, high-quality clinical development program. You will lead cross-team medical input for studies, feasibility activities, data review, and interactions with investigators and regulators as needed.

Responsibilities

• Act as a mentor for other CRDs and Clinical Scientists on a same project/TA
• Collaborate with functions to ensure uniform, aligned operational approach (e.g., harmonizing study documents, ES, protocols, etc.). Within a project, provide leadership, build consensus, coordinate action plans with other CRDs and stakeholders to resolve project-related study issues, anticipates potential issues (sharing lessons learned) across the project or study teams. He/she raises study or project-level issues to TA Heads, as relevant and shares relevant information within and beyond Project teams.
• Take on as necessary the CRD role:
  • Provide medical expertise to the clinical studies (except select Exploratory Pharmacology studies) and/or registries (eg: protocol, Key Results, Clinical Study Report)
  • Support other clinical development activities (e.g., pressure test and cluster feasibility, medical review and validation of clinical data, study risk assessment)
  • Contribute to the clinical part of submission dossier for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China and answers to questions from health authorities
  • Provide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators
  • Be the medical reference in the Clinical Study team, ensuring the medical relevance of the clinical data
  • Interact with other CRDs in the project, Global Project Head, The PV Rep, Regulatory and other key functional reps

Qualifications

• Understanding of pharmaceutical product development and lifecycle management gained through ~4 years of clinical development and medical experience
• Excellent scientific and medical/clinical expertise
• Excellent expertise in clinical development and methodology of clinical studies
• Excellent communication skills (verbal and written) for interactions across functional areas and with regulatory agencies
• Demonstrated capability to challenge decisions and the status quo with a risk-management approach
• Ability to negotiate to ensure operational resources are available for continued clinical conduct
• Fluency in written and spoken English
• Excellent teaching skills, demonstrated ability to assist and train others
• Ability to work within a matrix model
• International/intercultural working skills
• Open-minded to apply new digital solutions
• At least 4 years in pharmaceutical industry or CRO, previous experience in late-stage clinical development

Education

• MD or equivalent (DO, MBBS)
• Specialization and training as a Rheumotologist