Vice President, Experimental Medicine - Fremont, CA | Biospace
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Vice President, Experimental Medicine

Ardelyx Inc.

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Location:
Fremont, CA
Posted Date:
5/17/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Medical Doctor
Areas of Expertise Desired:
Vice President,

Job Description


Ardelyx® is building an integrated biopharmaceutical company with a gastrointestinal and cardio-renal focus. Our mission is to serve patients through the discovery, development and commercialization of minimally-systemic therapeutics that target intestinal receptors and transporters to address unmet medical needs.

We seek a Head of Experimental Medicine who will lead the transition of preclinical programs across a variety of disease areas into Phase 1 through proof-of-concept in man. The ideal candidate will be a collaborative physician-scientist with extensive experience in leading early clinical and translational medicine efforts across multiple therapeutic areas. In this role the successful candidate will establish a translational mindset of enabling early decisions on development and early clinical candidates. The role reports into the Chief Scientific Officer (CSO) with a dotted line into the SVP, Drug Development with key interfaces to clinical operations, regulatory and QA staff.

Position Responsibilities:

•   Overall responsibility for experimental medicine activities that span from late preclinical through clinical development including Phase 1 to Proof-of-concept in man
•    Establishing a framework for design, conduct and reporting of experimental medicine clinical studies
•    Designing early clinical development plans through Phase 1 and PoC.
•    Developing integrated clinical pharmacology packages supporting clinical development through PoC
•    Developing plans to qualify biomarkers to assess target engagement, proof-of-biology or preliminary proof-of-concept, and executing on plans through interface with Clinical functions
•    Through embedding into project teams at lead optimization phase, will understand key opportunities and challenges with targets, mechanisms and compounds which can be addressed with biomarker, toxicity marker strategy in Phase 1 and 2
•    Working with KOLs and advisory boards to establish and pressure tests clinical plans through PoC
•    Creates successful operational interface with clinical/development function for clinical operations, QA and regulatory functions
•    Measures of success include increasing the ability to make early Go/No-  Go decisions in Phase 1 and optimizing cycle time from DC to FIH to PoC
•    Additional activities include
•    Interfacing with COO and CMO function to determine optimal indication for a given program as a function of unmet need, feasibility, regulatory challenges, cost and Ardelyx corporate strategy
•    Performing due diligence across the preclinical and clinical development spectrum on internal and external in-license opportunities in collaboration with business development

Requirements


•    MD or MD/PhD with 10-15 years of experience in pharmaceutical, biotech company. PhD with appropriate experienced possible
•    Experience in transitioning programs from late preclinical phase through proof of concept, leading the development of appropriate de-risking strategies to address questions in the clinic
•    Exposure to early development required; clinical pharmacology desired
•    Experience in GI, cardiorenal and metabolic disease is optimal
•    Experience writing protocols, with expertise in clinical operations and regulatory affairs important; experience running these functions not required
•    Proven ability to lead by influence, communicate well with others, and work effectively in a collaborative environment

As a member of the Ardelyx team, you will help develop therapeutics that are designed to act in the gastrointestinal tract with minimal systemic exposure. Our drug candidates target important diseases and conditions. We are developing novel therapeutic agents that address unmet medical needs, with a gastrointestinal and cardio-renal focus.

We are seeking the best in class scientists, advanced thinkers, and people who thrive on collaboration to co-create the future. You will be working with some of the industry's best scientists in a team environment focused on world class research. Ardelyx offers a competitive total rewards package, perks and an innovative and dynamic culture.

Ardelyx, Inc. is an Equal Opportunity Employer.