Director / Senior Director of Clinical Affairs

Pendulum is on a mission to help people improve physical and mental health by creating products that leverage the microbiome, including the gut-brain and gut-bone axes.  We are researching, developing and commercializing a novel class of rationally designed live SynbioticsTM (probiotics + prebiotics) that have demonstrated clinical efficacy to assist with the management of conditions like metabolic syndrome, inflammation and neurodegeneration. 
Pendulum has created proprietary pipelines to build a unique discovery platform that identifies key, novel bacterial strains and the prebiotics that feed them. We are a highly collaborative team of scientists, engineers, physicians, marketers and salespeople interested in improving human health by using the latest research from diverse fields, such as, microbiology, molecular biology, high-throughput genomics, distributed computing, pharmaceutical development and nutrition. We believe strongly in an individual’s transparency and strong communication to enable the most effective and efficient path to team success.
If you’re interested in building a new category of products that will help improve the lives of people globally and you love working in a cross-functional, collaborative, inspiring environment, please continue reading!
We are currently seeking a Director of Clinical Affairs to join Pendulum’s Clinical Team. As the Director, you will work directly with the Chief Medical Officer and members of the Clinical Department to provide medical support for clinical development activities including clinical trials, provide medical support for marketing and conduct traditional medical affairs activities.
The successful candidate will contribute to study planning, study design, data analysis and study publications. You will provide medical support to the marketing, research and business development teams. You will also have an outward-facing role interacting with academic investigators and members of various clinical communities.  Internally, you will have the opportunity to work with the Manufacturing, Molecular Biology, and Compute Teams to support and enable the discovery and development of novel, life-changing microbiome interventions. The successful candidate will be able to learn new systems quickly and adapt to constantly changing needs as Pendulum rapidly expands capabilities in terms of projects and processes. The successful candidate will welcome the opportunity to coordinate and shepherd individuals and internal teams to efficiently and effectively complete clinical trials.

Responsibilities

• Medical Support:
• Work closely with the Chief Medical Officer to provide medical oversight and support of clinical studies, both sponsor-driven and investigator-initiated studies
• Collaborate with Chief Medical Officer, Vice President of Research and Development, Associate Director of Clinical Studies, Compute team and external collaborators in crafting study designs and analysis plans
• Oversee safety monitoring of clinical studies as well as marketed products
• Serve as a direct contact and resource of medical and clinical expertise for internal team members 
• Coordinate study data review
• With guidance of the Chief Medical Officer, co-author and coordinate manuscript preparation for submission
• Support investigator meetings and clinical site visits as required
• Identify and assist with the design of preclinical studies needed to pursue observations from clinical studies
• In collaboration with research, identify appropriate study sites for preclinical studies
• Maintain an efficient, collaborative relationship between clinical and R&D groups, and the manufacturing groups.


• Medical Marketing Support:
• Assist with the identification and planning of both preclinical and clinical marketing support studies
• Maintain an efficient, collaborative relationship between clinical and marketing groups
• Provide clinical support for crafting marketing messages as needed
• Partner with marketing and R&D to create and maintain an integrated publication plan
• Support the creation of various white papers as needed


• Medical Affairs Activities:
• Seek opportunities to educate regarding the microbiome in the medical and academic communities
• Give presentations as requested
• Identify key academic investigators within the academic community who are potential collaborators and develop relationships with them
• Identify regional thought leaders within the realm of healthcare providers involved with our targeted audiences and collaborate with them to enhance the awareness of the potential of microbiome-based interventions
• Solicit appropriate investigator-initiated studies and preclinical collaborations

Requirements

• Ph.D preferably in life sciences, biological science, nursin