25 days old

Director or Sr. Director Level, Clinical Development

Kelly Services
San Carlos, CA 94070
**Director or Sr. Director Level, Clinical Development**

**20 hours per week, 6+ months contract**

The Clinical Development Department is seeking an interim consultant at a Director or Senior Director who is greatly experienced in clinical-pharmaceutical trial conduct, analyzing and interpreting clinical trial data, as well as writing/reviewing clinical study protocols, IB updates and other clinical-regulatory documents. The consultant collaborates with internal stakeholders such as Clinical Operations, Regulatory Affairs, Clinical Pharmacology, Data management, Biometrics, Medical Affairs as well as with external collaborators such as study investigators and their staff, CROs and vendors operating. S(he) will be able to work in a highly scientific and fast-pace clinical research environment. The candidate will have a relevant scientific-academic background with a PharmD, PhD or MD degree.

The main responsibilities include:

+ Internal and external clinical science representative of clinical trials and clinical programs. Expanded responsibilities include accountability for specific trial aspects, e.g. protocol development or implementation of technical trial procedures in collaboration with vendors or key opinion leaders. Examples are the implementation of skin photography procedures in conjunction with a vendor or development of a skin biopsy procedure methodology by KOLs.

+ Designs, authors and reviews clinical trial protocols, protocol amendments, informed consent documents, investigator brochures, CRFs, monitoring plans, data and statistical analysis plans, etc. The individual may develop the plans and drafts self-sufficiently after an initial strategy discussion, followed by optimization through the team and supervisor.

+ Authors clinical study reports and sections of regulatory submission documents, such as, INDs, CTAs, NDAs, MAAs, regulatory agency briefing packages, etc. The individual writes complete sections of such documents and is responsible for following an effective review process.

+ Responsible for aspects of the scientific execution for the initiation, conduct and monitoring of Phase 1-3 clinical trials as appropriate

+ Prepares, presents, and defends complex aspects of protocol design and/or study data at internal meetings or investigator meetings. The individual will present aspects of the protocol or study data to internal and external stakeholders.

+ Actively engages in the planning, preparation and participation of regulatory meetings, e.g., Pre-IND-, End-of-Phase 2 meeting, or other regulatory meetings.

+ Collaborates with external stakeholders such as study investigators and their staff, Key Opinion Leaders, CROs and vendors during all phases of the clinical trial and program. The individual will be held accountable for the outcome of interactions as appropriate.

+ Interprets clinical results from in-house clinical trials or external trials and translates the conclusion of such results for internal and external stakeholders. Example is collaboration with Clinical Operations, Regulatory colleagues and vendors to facilitate or execute on results postings on and EudraCT for applicable completed trials. Has a knowledge of the required content for posting and able to generate trial results content from CSRs. Bonus if previously had experience on results postings on either clintrials or EudraCT portals.

+ Critically analyzes and synthesizes complex information from reviews of the scientific/clinical literature

+ Prepares and reviews draft abstracts, presentations, posters, and manuscripts for publication in consultation with other team members/collaborators

For immediate consideration, email resume directly to the recruiter:



**Why Kelly** **** **?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (
Posted: 2021-10-01 Expires: 2021-11-01

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Director or Sr. Director Level, Clinical Development

Kelly Services
San Carlos, CA 94070

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