Rhythm Pharmaceuticals Director / Sr Director, Genetic Diagnostics in Boston, Massachusetts
Rhythm is a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of obesity. Working at Rhythm means that you are part of a team that’s passionate about transforming the lives of people living with rare genetic diseases of obesity. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.
Rhythm Pharmaceuticals is seeking an experience Director, Genetic Diagnostics to join the Translational Research and Development (TRAD) team. Rhythm is a precision therapy biotechnology company developing treatments for rare genetic diseases of obesity (RGDO).
The successful candidate will lead the Rhythm’s NGS-based RGDO genetic testing activities, including establishing and managing partnerships with clinical genetic testing labs. In collaboration with clinical, regulatory and commercial functions, leveraging their expertise in genetics and diagnostics, they will lead the design and implementation of Rhythm’s strategy for RGDO testing and development of companion diagnostics.
This role will play a critical role in defining Rhythm’s precision medicine strategy for identifying and treating individuals with RGDO.
Responsibilities and Duties
Manages active diagnostic partnerships with clinical laboratories performing genetic diagnostics for the company’s trials and sponsored testing programs.
Leads due diligence efforts for selection of and maintenance of third-party genetic laboratories (diagnostic and CROs) to ensure compliance with relevant regulatory requirements. Supports effective implementation of contracts and protocols.
Leads development of Rhythm’s diagnostic strategy in support of company’s clinical and commercial objectives.
Collaborates closely with clinical, regulatory and commercial teams to ensure successful implementation of sponsored genetic diagnostic and companion diagnostic activities.
Leads evaluation of novel diagnostic strategies and technologies to accelerate growth of RGDO testing globally.
Support regulatory team in CDx submissions to FDA/CDRH and other regulatory agencies worldwide
Provide expertise to company in keeping with developments in the regulatory, competitive and technology diagnostic landscape
Qualifications and Skills
Doctoral degree in relevant field
10+ years of relevant experience, including 5+ years of post-doctoral work experience and success at diagnostic or biotech/pharmaceutical companies with a focus on genetic diagnostics
Deep understanding of state-of-the-art NGS platforms and technologies
Experience with the development and support of diagnostic SOPs and ICFs
Experience with regulatory framework governing genetic testing under CLIA/LDT regulatory framework, as well as CDx development and knowledge of FDA/CDRH processes and regulations preferred
Creative thinker, problem solver, innovator, good communicator, and team player
This role is based in our Corporate office in Boson, Massachusetts. Candidates applying must be willing and able to be in the Boston office once it is safe to do so, per State and Federal COVID-19 guidelines.
This role will involve future travel, TBD post availability of COVID-19 vaccine
More about Rhythm
Rhythm is a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic disorders of obesity. The company is targeting the melanocortin-4 receptor (MC4R) pathway that is impaired due to genetic variants. This is a key biological pathway that regulates weight and hunger. A central element of Rhythm’s mission is to improve the understanding of these disorders and develop management strategies for patients who have no treatment options available to them. Rhythm was founded in 2008 and is based in Boston, MA. The company’s clinical development program is currently focused on several rare genetic disorders of obesity, all driven by genetic variants in the MC4R pathway. For healthcare professionals, please visit www.UNcommonObesity.com for more information. For those who may be affected or would like to learn more, visit www.LEADforRareObesity.com for more information.
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