Senior Director, Clinical Operations, Oncology
Proclinical is currently recruiting for a Senior Director of Clinical Operations of Oncology with a leading biotechnology company located in Cambridge, MA. Successful candidate will lead clinical operations team and initiatives across Oncology projects, manage external contractors and CROs, as well as co-lead organizational initiatives across all therapeutic areas, in conjunction with the other Clinical Operations Leads.
- Manage the cross functional leadership related to all aspects of oncology clinical trial operations.
- Lead in/support the selection, oversight, and management of CROs and other vendors.
- Develop/lead/maintain the review of clinical outsourcing strategies and plans.
- Oversee the trial lead's management of the oncology clinical trial budgets.
- Responsible for representing Clinical Operations on cross-functional project teams and Vendor/CRO operational meetings and ensuring compliance with operational standards and procedures.
- In conjunction with Risk Management, lead and oversee vendor oversight activities such that they are conducted in accordance to the company and ICH/GCP standards for each Oncology study.
- Along with other Clinical Development personnel, represent the Company externally to Investigators and trial site administrators.
- Oversee/collaborate on and contribute to activities that support any GCP audits and regulatory inspections related to clinical trial conduct.
- Maintain oversight and participate in the creation/review/maintenance of departmental and organizational SOPs to ensure wholistic compliance.
- Develop and maintain strong, collaborative relationships with key stakeholders both within and outside of the company.
Skills and Requirements:
- Advanced degree preferred, with at least a Bachelor's in a science-based subject.
- 10+ years' global trial management experience in a clinical research environment, most of which should be in industry and in Oncology (solid experience in hematology indications preferred).
- Substantial experience in early phase therapeutic drug development and proven track record of success.
- Multi-dimensional Clinical operations background with capability of devising plans for operational challenges such as site activation, patient enrollment, monitoring oversight, protocol deviation management, data cleaning, site/program budget negotiations, etc.
- Excellent team building and collaboration skills, for both the Oncology team and the organization.
- Cross collaboration proficiency with other internal and external functions within development as also Research, Drug Supply, Compliance, Finance, etc.
- Thorough command of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies in the United States, Europe and rest of world with past experience in regulatory GCP inspections/audits.
- Outstanding verbal and written communication skills for clinical authoring experience including protocols, investigator brochures, etc.
- Excellent organizational and multi-taking ability skills and the ability to work independently, in a self-driven manner.
- Proven track record of effective leadership in the context of a multi-disciplinary team in the biotech or pharmaceutical industry.
- Creative, capable problem-solver.
- Experience in establishing and maintaining relationships with key opinion leaders.
If you are having difficulty in applying or if you have any questions, please contact Natasha Patel at (+1) 617-778-7319.
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.