Senior Clinical Scientist
99 Coolidge Ave. Suite 450 Watertown, MA 02472
Development – Clinical /
Full-time /
On-site
COMPANY INTRODUCTION
Triveni Bio is breaking new ground in the identification of novel disease targets – working at the convergence of human genetics, best-in-class antibody design, and precision medicine. We are pioneering a Mendelian genetics-informed precision medicine approach to develop functional antibodies for the treatment of immunological and inflammatory (I&I) disorders. Our lead antibody program (TRIV-509) targets kallikreins 5 and 7 (KLK5/7) to directly impact skin barrier function, inflammation, and itch – providing a meaningful and much needed potential treatment option for patients with atopic dermatitis and other barrier disorders. In all the work we do, we adhere to our core values: patient impact, bold and rigorous science, open collaboration, kindness & respect.
SUMMARY
As Senior Clinical Scientist, you will be a key member of the Clinical Development team at Triveni, responsible for leading assigned clinical trial(s) and contributing to the overall clinical development plan for one or more assets. You will serve as the clinical lead for assigned trials, working cross-functionally with colleagues in Clinical Operations and other departments as well as with assigned contracted research organizations and vendors to ensure successful trial startup, delivery, and closeout. You will additionally collaborate with Regulatory Affairs and others on key regulatory documents. You will contribute to the broader clinical development plan in collaboration with Translational Medicine and other key colleagues.
As a member of a growing Clinical Development team, you will have the opportunity to contribute in a meaningful way to Triveni’s clinical development program from day one. You will work closely with the Head of Clinical Development and will have the opportunity to take on leadership opportunities for individual trials as well as to contribute to broader clinical development plans, including in close collaboration with Translational Medicine. This is an ideal opportunity for someone with strong medical monitoring background to contribute meaningfully to an exciting clinical-stage asset and to further develop skills in broader clinical development planning, regulatory strategy, and other aspects of clinical development.
RESPONSIBILITIES
· Develop protocol and related documents, including inclusion/exclusion criteria, endpoints, and other key components
· Monitor clinical trial data, ensuring adherence to protocols and good clinical practice (GCP) guidelines
· Serve as the primary point of contact on clinical and scientific aspects of the design, implementation, conduct, analysis, interpretation and documentation of assigned clinical trials, including questions from sites, IRBs, and health authorities
· Review clinical data to support the assessment of safety and efficacy of study drugs
· Develop study-specific plans, including medical monitoring plans, consistent with applicable SOPs
· May author and/or review clinical narratives in conjunction with pharmacovigilance
· Support development of other documents including regulatory documents (relevant parts of regulatory submissions/correspondence, Investigator’s Brochures) and clinical trial documents (eg Clinical Study Reports)
· Support the clinical development of assigned programs and supports the design and implementation of the development strategy
· Stay current with relevant medical literature, clinical trial methodologies, and ongoing clinical development in the therapeutic area
· Establish relationships with and communicate with advisers and other experts in the therapeutic area
· Work cross-functionally with Clinical Operations, Regulatory Affairs, Statistics, Translational Medicine and other functional areas, including contractors and vendors
EXPERIENCE & QUALIFICATIONS
· Advanced scientific degree (MD/MBBS, PharmD, PhD) or an equivalent level of professional, clinical and/or scientific education, training and experience
· Minimum 2 years of experience and success within a biotech or pharmaceutical company functioning in the capacity of clinical scientist/medical monitor
· Prior experience with and knowledge of medical monitoring as well as study start-up and close-out; experience in the Dermatology therapeutic area and/or regulatory interactions is preferred
· Knowledge of GCP and ICH guidelines
· Ability to work cross-functionally; external contractor and vendor management is preferred
Triveni Bio, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Official Triveni Bio applications will always be submitted through Lever, our ATS. Any applications that take you to other platforms could be fraudulent. We do not use text or chat applications to conduct interviews or make job offers. Official Triveni Bio correspondence will always be conducted from email addresses ending in @triveni.bio. Please disregard any other communication that does not originate from this domain name. If you receive any suspicious requests or communications, please verify their authenticity before responding.
