Actalent Director Clinical Operations in Boston, Massachusetts
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 clinical development and scientific reporting.
The Director will also provide scientific and GCP oversight of clinical operations outsourced to CROs.
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
Additional Skills & 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
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
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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