Clinical Operations Director job in Philadelphia, USA

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First Name*

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Job type: Permanent

Discipline: Program Manager / Director, VP/Head of Clinical Operations

Location: United States

This vacancy has now expired. Please see similar roles below...

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.

Job Responsibilities:

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 m.jacobs@proclinical.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.

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