Clinical Research Director - RBD

Role Summary

Location: Cambridge, MA; Morristown, NJ. The Clinical Research Director (CRD) provides medical and scientific leadership for the creation and implementation of global clinical development plans and related activities to develop novel therapeutics for patients with high unmet needs. The CRD serves as a principal team member within the development group, accountable for the clinical aspects of the Global Clinical Development Plan (GCDP) and for the design, execution, and analyses of clinical trials within the GCDP. The CRD collaborates with cross-functional teams to advance product development and regulatory submissions.

Responsibilities

• The CRD is a principal team member within the development group and provides medical and scientific leadership in the development of new therapies; is accountable for the clinical aspects of the Global Clinical Development Plan (GCDP) and for the design, execution, and analyses of clinical trials within the GCDP.
• The CRD becomes an expert in the disease and experimental therapy, maintaining knowledge through medical education, current scientific literature, attendance at scientific conferences, and relationships with external experts, and communicates developments to appropriate internal staff.
• The CRD works with the Clinical Science Operations (CSO) team to implement selected clinical trial(s) within the GCDP, including study initiation, study conduct, and preparation of study reports.
• The CRD leads the Clinical Development Subteam (CDST), partnering with the CSO Project Lead (PL) and is accountable for the development of the clinical development strategy, providing clinical input and leadership to the team with the Global Project Head (GPH) and Project Manager (PM), including relevant components of the GCDP in line with product profile and corporate goals.
• In the creation and implementation of the GCDP, the CRD has a leadership role in partnership with other CDST members (GPH, CSO PL, regulatory, statistics, and PM).
• The CRD leads the preparation of clinical documents/reports for regulatory submission and attends meetings with regulatory authorities.
• The CRD works with Commercial and Medical Affairs to support the creation of the product value proposition and global product positioning.
• In support of licensing and acquisition activities, the CRD collaborates with business development and provides medical due diligence on opportunities.
• The CRD liaises with the Medical Affairs group to contribute to activities such as review and approval of investigator sponsored studies and contribution to manuscripts involving company-sponsored studies.
• The CRD liaises with the Research group to contribute to the science discovery strategy and provide medical assessment of disease and therapeutic targets.

Qualifications

• Required: 5+ years of pharmaceutical/biotechnology industry or combined industry/academic experience, with experience in clinical trials
• Required: Working knowledge of GCP
• Preferred: Specialization in hematology
• Preferred: Academic experience as a principal investigator
• Preferred: Strong analytic thinking and the ability to assess scientific data and medical literature
• Preferred: Excellent written and verbal communication skills. Experience writing abstracts/manuscripts/study reports strongly desired
• Preferred: Collaborative team work ethic
• Preferred: Ability to work and lead a matrix team

Education

• MD