Associate Director Clinical Development - Oncology
Proclinical is currently recruiting for an Associate Director of Clinical Development for a pharmaceutical company located in Gaithersburg, MD. Successful candidate will lead and manage defined clinical deliverables across a broad range of activities.
- Lead a cross functional team of clinical experts in the planning and delivery of a defined clinical project to scope, quality, budget, time, managing resource and risk. These could include large studies/package of studies, clinical submission teams, regulatory defense, inspection readiness, payer evidence.
- Provide clinical operations expertise into the project to support governance interactions and project start-up.
- Responsible for project management. This includes the development, base-lining and maintenance of realistic, up to date and appropriate quality, project and study plans in agreed systems
- Identify and resolve issues within the clinical project including the follow up of the issue to the appropriate individual/functional/governance group for resolution.
- Lead a large/complex work package and the process to identify and solve operational issues and drive delivery to plan through internal or external partners.
- Act as AZ project lead to collaborate with external partners for externally led/outsourced studies.
- Be responsible for ensuring timely compliance with companywide governance controls.
- You may be assigned responsibility for leadership and program/project management of non-drug project work.
Skills and Requirements:
- BA/BS or equivalent, preferably in medical or biological sciences or discipline associated with clinical research. Having an advanced degree is helpful.
- Considerable experience in clinical research and/or oncology drug development gained in an academic, pharmaceutical or CRO environment.
- Deep understanding of clinical operations, project management tools and processes.
- Proven experience of clinical development / drug development process in various phases of development and therapy areas.
- Experience of leading clinical projects and deliverables or similar expertise from other areas of drug development.
- Project management certification.
- Knowledge of process improvement methodology such as Lean Sigma/Change Management.
- Experience within the field of Immuno-oncology.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Nicole Aganon at (+1) 347-293-1161 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.