Medical Director/Sr. Medical Director - San Diego, CA | Biospace
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Medical Director/Sr. Medical Director

Regulus Therapeutics, Inc.

Location:
San Diego, CA
Posted Date:
8/10/2017
Position Type:
Full time
Job Code:
537
Salary:
Required Education:
Medical Doctor
Areas of Expertise Desired:
Medical Director,

Job Description


We are currently seeking a highly experienced and motivated Medical Director/Sr. Medical Director to be part of a unique and exciting opportunity in drug discovery.

The Medical Director/Sr. Medical Director plays a key, hands-on leadership role in developing and executing the scientific and clinical strategy for all products in development.  The Medical Director/Sr. Medical Director will work collaboratively across all functional areas including Clinical Operations, Discovery, Business Development, Biostatistics/Data Management, Regulatory Affairs, and Medical Affairs. This position will report directly to the Chief Medical Officer.

Responsibilities:

•   Key clinical/scientific leadership role in managing multiple Phase 1 to 3 clinical studies across all functional areas of the drug development process
•   Represent clinical development on cross-functional project teams, steering committees, and corporate partnering discussions
•   Lead Medical/Clinical interactions with regulatory authorities (e.g. FDA, EMA, etc.)
•   Develop and cultivate strong relationships with thought leaders, investigators and key opinion leaders.
•   Manage medical monitoring aspects of all clinical trials (e.g. safety data review, safety committee participation, signal detection review for DSUR, etc.)
•   Supervise and participate in the review, analysis and interpretation of clinical study data
•   Lead in the creation of Clinical Development Plan(s); provide clinical development content and review overall content of Product Development Plans and Target Product Profiles
•   Guide the preparation and review of investigator brochures, clinical protocols, statistical analysis plans, and clinical study reports
•   Develop medical/clinical content for regulatory submissions (e.g. pre-IND meeting materials, IND and/or NDA submission packages, draft package insert labeling, etc.)
•   Work collaboratively with other internal and external clinical staff in trial execution and oversight (e.g., biostatisticians, data managers, clinical operations, medical writing, etc.)
•   Support Business Development efforts by performing clinical assessments on relevant discovery or clinical stage products; serve as medical/scientific expert to Business Development on strategic partnerships
•   Manage, mentor, and/or professionally develop assigned clinical team members as appropriate
•   Attend conferences and remain current with relevant therapeutic area information

Requirements


•   Board certified MD, MD/PhD, DO degree
•   8+ years clinical development experience in general translational medicine / early clinical development.
•   Ability to manage the full portfolio across several disease areas.
•   Basic Science and Clinical research experience in a medical specialty with a proven record of quality publications.
•   Ability to work independently and collaboratively, prioritizing tasks efficiently and meeting clinical and corporate timelines in an intense, fast-paced environment
•   Track record of successfully executing on Phase 1-3 clinical trials from conceptualization to completion
•   Broad, in-depth understanding of all aspects of drug development including: clinical trial design, execution, biostatistics/data management, US and international regulatory and quality standards, and pharmacovigilance requirements
•   Must be a critical thinker who demonstrates innovative and nimble approaches to problem solving
•   Experience with leveraging support from external contract research (e.g. CROs)
•   Understanding and knowledge of Good Clinical Practice and ICH guidelines
•   Recognized leadership in clinical research and the ability to network, establish collaborations and influence external experts.
•   Strong desire to be part of a highly innovative company aimed at transforming the lives of people with serious diseases, their families and society  
•   Ability to travel as required, including international travel (average 20-30%)


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 maintains its corporate headquarters in La Jolla, CA.  For more information, please visit http://www.regulusrx.com.  

Regulus is located in San Diego, California and has 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: 537

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