Clinical Trial Manager - San Diego, CA | Biospace
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Clinical Trial Manager

Regulus Therapeutics, Inc.

Location:
San Diego, CA
Posted Date:
6/30/2017
Position Type:
Full time
Job Code:
541
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Clinical Trial Manager,

Job Description


Regulus Therapeutics Inc. (Nasdaq: RGLS) is a biopharmaceutical company located in San Diego, California leading the discovery and development of innovative medicines targeting microRNAs.

We are currently seeking an experienced Clinical Trial Manager to join our team to advance our efforts in phenotypic screening for novel drug targets and compounds. For more information, visit www.RegulusRx.com.

Position description and scope:

The successful candidate will be a member of a Clinical Team and will provide important research experience and skills for the organization. Reporting to the CMO, the incumbent will be responsible for effectively conducting clinical trials from start to finish.

Job responsibilities

1.   Coordinate, manage, and oversee all activities on clinical projects including managing in-house CRAs, CROs and vendors.  Provide updates to the CMO regarding progress towards project goals.
2.   Partner with Regulatory and Quality functional areas to ensure compliance with regulatory agency, ICH, and GCP guidelines
3.   Provide mentorship to clinical teams (e.g. advise regarding appropriate communications and problem-solving with project clinicians, clinical sites and investigators).
4.   Identify prospectively any issues that will interfere with meeting project goals and recommend solutions.
5.   Ensure clinical trial documents are filed, maintained, and archived in audit-ready and due diligence-ready condition.
6.   Oversee administrative issues for clinical trials including all regulatory documents required for the initiation of clinical trials and reviewing scope of work with vendors and CROs

Requirements


Position Requirements:

•   Bachelor’s degree in a life science/Master’s preferred or its equivalent in health care or biological science.  
•   Minimum of seven years of clinical operations experience in the biotechnology or pharmaceutical industry, with at least one year of managerial/supervisory experience.
•   Demonstrated understanding of all applicable regulations and guidelines governing drug development including ability to apply these to overall strategic drug development.
•   Excellent working knowledge of Good Clinical Practices; ICH guidelines; trial initiation and management practices and procedures;
•   Excellent leadership, interpersonal and communication skills.  Works efficiently with others to accomplish goals and resolve problems.  Encourages cooperation, collaboration, and co-ownership of processes.  Innovative problem solver.

Personal Competencies:

•   Ability to work on complex problems
•   Willing to travel for training, site initiation visits, and/ or to assist with complex, difficult clinical sites
•   Effective interpersonal skills, including both written and oral communication skills
•   Highly organized, strong analytical skills, highly attentive to details, and strong work ethic
•   Ability to work within schedules and deadline
•   Team player, intensely committed to success and getting the job done well in a highly dynamic environment
•   Ability to manage multiple projects, prioritize, and function in a fast-paced entrepreneurial environment
•   Self-motivated, ability to work independently while also willing to follow protocols

Regulus Therapeutics Inc. (Nasdaq: RGLS) is a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs.  Regulus has leveraged its oligonucleotide drug discovery and development expertise to develop a well-balanced microRNA therapeutics pipeline complemented by a rich intellectual property estate to retain its leadership in the microRNA field.  Regulus is advancing several programs in renal, hepatic and central nervous systems diseases.

Regulus is located in La Jolla, California and is led by a seasoned executive team experienced in corporate management, business, science, drug discovery and development. Regulus' scientific advisory board consists of world-class scientists and some of the foremost authorities in the field of microRNA research.

Excellent salary and benefits package offered.

You can visit our website to find out more about our company and culture: www.RegulusRx.com.

Reference job code: 541

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Regulus Therapeutics, Inc, is proud to be an EEO Employer.