Director, Clinical Development

Director, Clinical Development

POSITION SUMMARY

The Director of Clinical Development will provide direction on clinical plans, contribute to clinical deliverables including clinical study conduct and oversight, study reports, scientific abstracts and manuscripts, and regulatory submissions in support of Vericel clinical development and scientific reporting.

The Director will also provide scientific and GCP oversight of clinical operations outsourced to CROs.  

ESSENTIAL FUNCTIONS

Core Responsibilities

• Provide scientific expertise to develop and oversee clinical projects including registration and non-registration studies
• Provide strategic input as well as development support for clinical program plans and study protocols
• Responsible for drafting and finalizing clinical study protocols and amendments
• Responsible for drafting, review, and finalization of statistical analysis plans in collaboration with biostatistician
• Responsible for authorship of clinical sections of regulatory submissions
• Responsible for the development and maintenance of clinical SOPs
• Perform data content and study document reviews (e.g., blinded data reviews, review of exploratory and final analyses, review of draft reports and regulatory documents)
• Provide scientific training for Clinical Operations and CRO personnel associated with study execution
• Participate in the preparation and review of scientific meeting abstracts, presentations, and manuscripts
• Represent company to external parties such as business partners, contract medical writers, contract biostatisticians, expert consultants, investigators, and the scientific community
• May participate in the selection and oversight of vendors

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Basic Qualifications:

• MS with 10+ years of experience working in pharmaceutical/biotech industry clinical development
• Broad understanding of clinical development and US pharmaceutical regulatory requirements
• Previous contributions to IND/BLA/NDA regulatory submissions (writing and review)
• Able to develop innovative/creative solutions to complex problems
• Able to manage several projects simultaneously, to manage conflicting priorities, and to be flexible when priorities change
• Excellent interpersonal and communication skills including demonstrated success in working on cross-functional teams in a highly matrixed environment.
• Able to manage staff

Preferred Education and Experience:

• PhD or equivalent in Biology, Biochemistry, Pharmacology, Epidemiology, or related fields IND/BLA/NDA writing or defense experience
• Clinical development experience with autologous cell therapy
• Translational medicine experience
• Demonstrated success in manuscript writing/authorship
• Past interaction with FDA and other regulatory agencies

WORKING CONDITIONS AND PHYSICAL DEMANDS

• Travel to attend professional development conferences or to visit research collaborators/investigators

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