Clinical Operations Director
Proclinical is currently recruiting for a Clinical Operations Director with a gene therapy program located in Philadelphia, PA. As the Director of Clinical Operations, you will have experience driving a pre-clinical study into Phase I and through clinical development.
- Ensure that clinical stage programs achieve program objectives within established timelines, budget, and quality standards.
- Take the lead in selecting external vendors that will support clinical operations, developing strong relationships and managing all contractual agreements.
- Lead the clinical operations team in the execution of clinical studies in conformance with Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) Guidelines.
Skills and Requirements:
- BS degree in Life Sciences, Public Health or other related discipline, with 5+ years of experience in Clinical Operations within biotech or pharmaceutical industry required. Record of success in positions of increasing responsibility in study execution is also required.
- Advanced degree preferred e.g. MS, PhD.
- Clear understanding and experience applying ICH/GCP.
- Advanced understanding of drug development processes and key operational interfaces..
- Proven track record in operational delivery of phase 1-3 global clinical trials - results orientated.
- Strong scientific/therapeutic expertise in rare diseases preferred.
- Demonstrated ability to plan, organise and manage resources to bring to successful completion specific study or project goals and objectives in accordance with defined quality and time based metrics.
- Demonstrated expertise in the identification, evaluation and selection of key global preferred provider partnerships.
- Thorough understanding of local and international regulations applicable to clinical development; demonstrative knowledge of regulatory requirements globally and prior success in providing timely and quality support of regulatory submissions.
- Excellent interpersonal communication skills and proven team leadership and team playing characteristics.
- Advanced ability to problem-solve.
- Proven ability to influence and negotiate with key internal and external stakeholders.
- Proven ability to manage large budget.
- Demonstrated success working independently and taking decisions with minimal supervision.
If you are having difficulty in applying or if you have any questions, please contact Mary Jacobs at (+1) 312-291-4181 or email@example.com.
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.