Director/Senior Director Clinical Operations - REMOTE
Proclinical is currently recruiting for a Director/Senior Director of Clinical Operations with a leading biotechnology company located both remote and in Gaithersburg, MD. Successful candidate will be responsible for the execution of the clinical trial operational plans to meet the overall development strategy.
- Ensure the activities that impact one or more projects are executed according to the clinical development plan.
- Develop and execute program-specific project and risk management plans (milestones, metrics, critical path) ensuring appropriate escalation as needed.
- Set program-level enrollment strategy including country and site selection plans and timelines to meet program objectives.
- Ensure program-level Investigational Product supply strategy meets the needs of the clinical program (s).
- Oversee the strategic selection of program-wide vendors.
- Develop and assess cost and resource projections of the program for portfolio plans and business development opportunities and serves as point of contact.
- Represent the clinical operations program on strategic governance bodies (e.g., Product Safety Team, Global Project Team, etc.)
- Co-lead the Clinical Sub Team with a Therapeutic Area representative.
- Ensure effective project or program communications to internal and external stakeholders through meetings, presentations, and other methods.
- Ensure consistency and compliance across all studies within a program.
- Partner with Quality Assurance to develop the strategic plan for regulatory audits and inspections.
- Participates in the evaluation of business opportunities (due diligence).
- Participates in resource prioritization across teams to ensure clinical operations strategic goals and milestones are achieved.
Skills and Requirements:
- Bachelor's degree preferably in a scientific field. An advanced degree is desirable.
- 15+ years of clinical research experience.
- Minimum of 10+ years supervisory experience.
- Experience in setting and driving strategy and leading a team in the management and completion of clinical studies.
- Demonstrated strong leadership competencies in a matrix environment in a clinical study leadership role.
- Excellent people management skills.
- Global experience in clinical research is preferred.
- Experience in managing multiple or complex projects.
- Participation in a regulatory submission is preferred.
- Ability to multi-task and flexible thinking in a fast-paced environment.
- Participation/experience with regulatory audits is preferred.
- Considered SME for SOPs, initiatives, and advancement of clinical operations as an organization.
- Experience in managing global trials from start-up to database-lock.
- Ability to travel globally up to 30% of time.
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 Natasha Patel at (+1) 617-778-7319 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.