Senior Clinical Research Director, Rare

Role Summary

Senior Clinical Research Director (Senior CRD) for the Rare Therapeutic Area, based in Cambridge, MA or Morristown, NJ. You will be the expert clinical lead for one or more indications in the development program, providing medical leadership and strategic and operational oversight. The role requires the ability to create synergies across the team and with external stakeholders, strong emotional intelligence, self-motivation, analytical skills, and the capacity to manage multiple tasks.

Responsibilities

• Provide medical expertise in the study team to conduct the clinical studies from early phases to late development milestones (LCM programs).
• Collaborate with other medical and clinical scientific experts (CRDs or DSDs) under the leadership of the Global Project Head, with the Global Safety Officer, Regulatory Strategist and other key functional representatives to deliver development strategy and assist with regulatory interactions.
• Develop the study-level regulatory documentation (Abbreviated Protocol, Protocol, Amended protocol) and lead study start-up activities (e.g., pressure test, competitive intelligence, patient engagement, cluster feasibility, study risk assessment, etc.).
• Provide medical input and support for activities related to clinical studies conduct, including responding to IRBs and health authority questions, training, medical data review, and medical information for the study team and investigators.
• Develop the clinical portion of briefing regulatory documents and the Common Technical Document for regulatory submissions (FDA, EMA, PMDA, etc.) and respond to health authority questions.
• Serve as the medical reference in the Clinical Study team, ensuring clinical relevancy of data and mentoring other project team members by indication.

Qualifications

• At least 4 years of experience in clinical development in the pharmaceutical industry, a CRO, or medical experience in clinical development in a healthcare institution.
• Languages: English fluent (spoken and written).

Skills

• Very good communication skills (verbal and written) for interactions across functional areas and with regulatory agencies.
• Excellent problem-solving capability.
• Demonstrated ability to challenge decisions and the status quo with a risk-management approach.
• Quality-focused with the ability to develop good practices using data-driven and risk management approaches.
• Multitasking and prioritization skills; ability to negotiate to secure operational resources for continued clinical conduct.
• Mentoring skills and evaluation of resources performance capability.
• Ability to work within a matrix organization and collaborate across international and intercultural teams.
• Open-mindedness to applying new digital solutions.

Education

• Medical Doctor (MD) preferred: GP or specialist; training in pediatrics or pediatric neurology is a plus.