Sr. Director/VP of Clinical Operations - San Diego, CA | Biospace
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Sr. Director/VP of Clinical Operations

Regulus Therapeutics, Inc.

Location:
San Diego, CA
Posted Date:
8/10/2017
Position Type:
Full time
Job Code:
543
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:
Clinical Operations, Director, Vice President, VP,

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 Sr. Director/VP of Clinical Operations to join our team to advance our compounds through clinical development. For more information, visit www.RegulusRx.com.

Reporting to the Chief Medical Officer, the Sr. Dir/VP of Clinical Operations will oversee the planning and conduct of clinical studies, oversight of study monitoring and adverse event reporting, and coordination of clinical data management in support of Regulus’ clinical programs.  The incumbent will contribute to clinical study design and overall project Development Plan in collaboration with the internal Regulus Project Teams, CROs, and external experts.   This role will be responsible for ensuring the timely delivery and quality of study results and reports.

Essential Duties and Core Responsibilities:

•      Contributes to the generation of comprehensive and feasible Clinical Development Plans.
•      Leads all planning and execution activities in support of clinical trials including protocol synopses, full study protocols, informed consent forms, CRFs, data acquisition/management/analysis plans, protocol posting, SAE reporting, and other required documents and processes
•      Manage, coach, and train others in the clinical operations department such as the clinical trial assistant, Clinical Project Manager, or others as designated. Provides training to Regulus scientists and staff on clinical trial methodologies and study conduct
•   Ensure clinical trial projects are properly resourced, managed and executed within budget, in accordance with established timelines and quality standards including inspection readiness
•   Represents the Clinical Operations function on Project Teams, management meetings, and external interactions (with experts, CROs, and Health Authorities).  Provides input on clinical trial designs.
•   Ensure consistency and reconciliation of data, terms, timelines etc., across vendors, team members, within documents and communications
•   Ensures the establishment of Processes, Workflows and SOPs as appropriate to ensure GCP compliance according to national and international standards, (e.g. FDA, EMA, ICH).  
•   Proactively generate and implement solutions to issues identified as trends or potential risks
•   Maintain communication (email, verbal, meetings, etc) with internal departments/functional team members (including vendors) as well as external corporate partners (as applicable) to ensure clear and consistent messaging is relayed to all relevant stake holders involved in our clinical trials as well as management
     

Requirements


Requirements:

•   Advanced Medical/Scientific Degree (MS, PharmD, PhD) strongly preferred, with 8-10 years of relevant pharmaceutical drug development experience with at least three years of managerial/supervisory experience
•   Demonstrated excellence in complex international project management and effectively managing multiple projects/priorities is required
•   Solves complex problems and uses highly developed independent judgment relating to national and international regulations, guidelines, investigator interactions and timelines.
•   Ability and interest to coordinate studies across a range of clinical indications
•   Must think critically, creatively and work independently
•   Excellent communication skills with an ability to efficiently and productively communicate both orally and in writing across a variety of functions and teams.
•   Demonstrated understanding of pharmaceutical regulatory requirements (both US and abroad), ICH, GCP and impact on development of clinical trials is required.
•   Experience in developing RFPs (preferred), selection of investigative sites/CROs/vendors and management of external resources is required
•   Self-motivation, resourcefulness and the ability to work in a fast-paced team environment are essential.  Intensely committed to success and getting the job done well in a highly dynamic environment
•   Excellent leadership, verbal/written, and interpersonal skills.  Works efficiently with others to accomplish goals and resolve problems.  Encourages cooperation, collaboration, and co-ownership of processes, problems, and solutions.

Special Working Conditions:

•   Travel to scientific and regulatory meetings and clinical sites will be required (approximately 5-15%, depending on portfolio stage).

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: 543

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