VP of Translational Medicine - San Diego, CA | Biospace
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VP of Translational Medicine

Regulus Therapeutics, Inc.

Location:
San Diego, CA
Posted Date:
8/10/2017
Position Type:
Full time
Job Code:
542
Salary:
Required Education:
Medical Doctor
Areas of Expertise Desired:
Translational, 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 VP of Translational Medicine 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 VP of Translational Medicine is accountable for leading and coordinating the Translational Medicine activities across the drug development programs in the Regulus portfolio.  Specifically, the role is to develop and implement strategies for transitioning programs from the preclinical stage to human Phase 1 and Proof of Concept (PoC) across all therapeutic areas.  In partnership with the Biology/Discovery Project Leaders and supporting functions, the incumbent will explore potential therapeutic applications of novel miRNA targets in support of generating a strategy for clinical development.

Essential Duties and Responsibilities:

•   Develops the First in Human (FIH) and POC strategy
•   Generates the Clinical Development Plan including resources needed for FIH clinical testing, PoC, various options for development and their sequence
•   Prepare and assure the overall quality of regulatory submissions (e.g., Investigational New Drug (IND) and Clinical Trial Authorization (CTA) for submission to Health Authorities?
•   Acts as the primary Regulus representative to Health Authorities (HA) and invite appropriate experts (internal and external) together with focus on early development
•   Serves as a senior Regulus representative to medically related experts and organizations (includes CROs, Advisory Boards)
•   Assumes responsibility as the Clinical Lead for PoC projects and, for example:
     o   Makes recommendations regarding endpoints, design, safety evaluations and initial dose selections?
     o   Assures overall quality of appropriate aspects of Clinical Plan, Study Synopses, Study Protocols, and Clinical Trial Reports (CTRs) and Summaries (e.g. slide format and executive summaries)
•   Prepares and implement project specific training programs and training material for internal staff and external organizations. ?
•   Management Responsibility: 0-3 direct reports
•   Budget & Financial Responsibility: recommending and conducting projects within budgetary guidelines
•   Contribute broad drug development and scientific knowledge to PIs, Project Teams, and Management Reviews

Requirements


Requirements:

•   MD or MD/PhD (or equivalent) with 10+ years of biotechnology or pharmaceutical drug development experience
•   Capable of working independently within a highly matrixed environment to support Team and Institute goals
•   Significant experience in clinical pharmacology (design of Phase 1 and Phase 2a trials)
•   Basic Science and/or Clinical research experience in a medical specialty with a proven record of quality publications
•   Strategic thinking, creativity, ability to work in a highly dynamic and innovative environment, recognized leadership in clinical research and ability to network with and influence external experts
•   Demonstrated success managing interactions with external CROs, consultants and other contract organizations
•   Ability to thrive in a fast-paced and dynamic environment with frequent course corrections
•   Excellent interpersonal skills, verbal and written communication skills
•   Strong organizational skills and attention to detail
•   High level of self-motivation, entrepreneurial spirit, and flexibility (openness to take on additional responsibilities as needed)

Special Working Conditions:

•   The employee may occasionally lift and/or move up to 25 pounds.  
•   Travel may be required (approximately up to 25%).

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: 542

NO PHONE CALLS PLEASE.  PRINCIPALS ONLY

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