Exosome Diagnostics is a privately held U.S. molecular diagnostic company based in Cambridge, MA and is focused on developing and commercializing biofluid-based personalized medicine tests, as well as building a companion diagnostics program with pharmaceutical companies. Exosomes and other microvesicles are shed into all biofluids, including blood, urine, and cerebrospinal fluid, forming a highly enriched source of intact, disease-specific nucleic acids. The company’s proprietary exosome technology makes use of this natural enrichment to achieve high sensitivity and specificity for rare gene transcripts and the expression of genes responsible for cancers and other diseases. The company is launching several products into the market using both a direct sales strategy through the company’s CLIA certified laboratory and in conjunction with strategic partners globally. The company is currently beginning a PMA approval process for its lead in vitro diagnostic tests in oncology, and leveraging its platform to develop and validate additional diagnostic signatures for both diagnostic purposes, as well as for compound associated signatures for pharmaceutical companies.
Having been the first company in the field of exosome diagnostics and founding the field of exosome diagnostics out of the Breakefield Laboratory at Mass General Hospital, the company has run over 30,000 patient samples, has overarching intellectual property in the space, and has completed numerous studies with prestigious partners and academic research institutions.
Exosomes are one of many different sub-populations of microvesicles that can be isolated from biofluids such as blood, urine and cerebrospinal fluid (CSF) and from which high quality RNA and DNA can be extracted and purified for analysis. Exosomes are shed by cells under both normal and pathological conditions. Please see this short video:
The company has ongoing investigations in prostate, brain and lung cancers and in neurodegenerative disorders. In addition, the company in continuing to expand biomarker discovery and signature validation programs through partnerships and contracted services with a variety of different pharmaceutical groups.
The Chief Medical Officer will join a dynamic and experienced leadership team dedicated to the successful development and product launch of Exosome Diagnostic’s in vitro diagnostics platform for PMA filings beginning in 2016. Candidates will provide essential medical guidance and expertise for all aspects of the effort and will have the opportunity to make a significant contribution to that success.
- As a member of an experienced senior management team, translate the corporate strategy of the company into an integrated clinical strategy for novel diagnostic assays/products leading to the regulatory submission and approval of product candidates.
- Provide medical expertise and knowledge to support the clinical development activities in positioning exosome based molecular diagnostics tests (mDx) in the relevant clinical setting to ensure optimal clinical development and commercial positioning for end users and strategic partners.
- Provide clinical guidance, support and education to customers as well as prospective customers, participate in the development of marketing material for use in hospital, clinician office and reference lab settings and support sales and marketing through presentations at customer sites, congresses and symposia.
- Provide strong scientific, medical and drug developmental leadership for the company and function as a key company liaison with KOLs, Scientific/Medical Advisors, DSMB’s, Board of Directors, Investors.
- Process and interpret data from trials including outcomes and findings leading to recommendations on clinical development and regulatory filing strategies.
- Willingness to be hands-on with trial recruitment activities and visiting clinical sites.
- Ensure that all clinical programs are conducted according to appropriate medical/scientific standards, on time and within budget.
- Manage the presentation of key clinical findings to internal and external stakeholders, including Exosome’s Board of Directors and venture fund partners on request.
- Support regulatory activities, as assisted by VP Regulatory Affairs, who will be a direct report by contributing to key regulatory submission writing and strategic positioning with FDA and other regulatory agencies.
- Keep abreast of emerging models in health care delivery; identify and define new and innovative strategies to achieve business goals and objectives.
- Monitor the competitive landscape closely and assist the company in adapting its strategy in response to changes in the external environment.
- Provide input for budget development – working closely with the Chief Operating Officer, Chief Executive Officer and SVP of Finance.
- Build upon and maintain the existing clinical network with external medical/scientific experts and key opinion leaders.
- Represent the company on the “sell-side” in any discussions/presentations with potential partners and present data at appropriate forums such as medical and scientific conferences.
The Ideal Candidate
- M.D. (certified in the field of oncology and/or neurodegenerative disease) with a minimum of 6-10 years in the pharmaceutical/biotechnology industry.
- Should be able to communicate with KOLs and advisors as a peer.
- Be excited and motivated to work in the emerging field of molecular diagnostics and personalized medicine.
- Be motivated by working in a smaller, high-growth company environment that prizes individual initiative and lack of large company structure.
- Experienced, self-motivated individual with sound analytical skills and a record of achievement in successful IND(s) and/or NDA/BLA(s) or equivalent; experience in filing and getting diagnostic products approved is a plus.
- Have a solid understanding of personalized medicine and existing as well as emerging new treatments in the field of oncology and be able to support the company in making the right strategic choices how to further develop its platform.
- Successful track record in drafting and implementing clinical trial protocols in oncology. Experience integrating biomarkers and companion diagnostics in clinical protocols is a plus.
- Knowledge of GCP and regulatory guidelines and experience with compliance issues addressed by health authorities, preferably in the US and EU.
- Demonstrated leadership of successful teams with a history of developing a culture of teamwork, collaboration and communication.
- Demonstrated understanding of strategic commercial drivers of oncology products.
- Ability to work and flourish in the culture of a small biotech company is a must.
- Good conflict resolution and problem solving skills.
- Good time management, the ability to handle multiple, competing tasks and strong decision making.
- Excellent written and verbal skills and the ability to communicate clearly, concisely and effectively.
- Experience in GU malignancies, especially prostate cancer would be a plus.
The compensation package is very competitive but will be weighted towards equity. The position will report to the President & CEO and is based in Boston, MA.