Sr Clinical Development Director, Respiratory &Emerging viruses job in San Francisco, USA

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Last Name*

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First Name*

Last Name*

Email*

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Are you an employer or a jobseeker?*

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First Name*

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Job type: Permanent

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

Location: United States

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

Proclinical is seeking a Senior Clinical Development Director of Respiratory and Emerging viruses for a global biotechnology company located in San Francisco, CA. Incumbent will typically lead multiple components of clinical trial programs in the clinical development of treatments for respiratory and emerging viruses.

Job Responsibilities:

Provides input into or leads the development of the Target Product Profile and Clinical Development Plan for assigned molecules /products.
Provides scientific and clinical guidance to cross-functional teams and colleagues to meet clinical development project deliverables and timelines.
Provides input into, or otherwise leads, clinical trial protocol design, clinical study reports and health authority inquiries.
Provides ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.
Manages the clinical development component(s) in the preparation/review of regulatory documents, investigator brochures and development plans.
Coordinates the collection and assimilation of ongoing data for internal analysis and review.
Coordinates and manages the preparation and/or review of data listings, summary tables, study results and scientific presentations.
Presents scientific information at scientific conferences as well as clinical study investigator meetings.
Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as the company's SOPs.

Skills and Requirements:

MD or equivalent with 2+ years' clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment.
Board certification in infectious diseases is preferred, ideally including familiarity with clinical infection disease medicine either in a broad setting or for posttransplant infection disease.
Experience in the biopharma industry is preferred.
Experience leading small cross-functional project teams in clinical research or development.
Experience taking the lead on study concept and protocol design, regulatory filings, clinical publications and presentations is preferred.
Proven effectiveness managing clinical project deliverables through matrix management.
Demonstrated ability to be a fast learner.
Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
Proven analytical abilities as demonstrated through past experience and/or academic research.
Understands drug development phases and the nature of associated clinical trials across phases.
Knowledge of FDA and EMA regulations, ICH guidelines, GCP and familiarity with standard clinical procedures.
Has advanced knowledge of R&D and major disease areas, as evidenced by effectiveness supporting clinical projects.
Strong communication and organizational skills.
When needed, ability to travel.

If you are having difficulty in applying or if you have any questions, please contact Cyrus Nazari at (+1) 619-754-8724 or c.nazari@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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