The Lexington Site is home to a growing Development organization, part of Novo Nordisk following its acquisition of Dicerna Pharmaceuticals, Inc. in December 2021. The Lexington Development team is responsible for leading the clinical advancement of Dicerna’s research pipeline of GalXC™ and GalXC-Plus™ RNAi investigational therapies and select candidates from the broader Novo Nordisk portfolio, targeting both rare and prevalent diseases. The Lexington Development team’s rich heritage of collaboration, calculated risk-taking and agility complemented by the scale and resources of the global Development organization, define a unique clinical development team that maintains its agility to efficiently advance clinical candidates through development. Located in one of the most vibrant biotechnology innovation hubs in the world, and part of the growing biotech ecosystem in Lexington, Massachusetts, the Lexington Site will offer you the opportunity to collaborate with extraordinary talent and to continuously develop, while working toward our collective mission to improve patient lives. Together, we are driving change. Are you ready to make a difference?
We are seeking an enthusiastic Senior Medical Doctor with a high degree of scientific acumen who is excited by cutting-edge biotechnology and wishes to take part in the unique opportunity to bring highly innovative pharmaceutical products through clinical development to market. The candidate is a team player, detail oriented with prior research experience, either in academia or industry.
In this role, the incumbent will help develop multiple products, including Dicerna's most advanced GalXC™ product candidate, DCR-PHXC, which is being created for the treatment of primary hyperoxaluria. In doing so, the Senior Medical Director will work across different functional teams to support the design and execution of clinical trials, the drafting of medical/ scientific documents, safety monitoring, and data analyses. In this high visibility position, the candidate will be interfacing with both internal and external stakeholders including KOLs and Principal Investigators.
- Support the VP Medical/Scientific Development as the US/international clinical lead for DCR-PHXC program to both internally and externally facing stakeholders.
- In conjunction with other relevant functional areas, help develop/ refine the strategic development plan for DCR-PHXC and other emerging novel therapeutics.
- Provide clinical and scientific expertise to the design of studies, writing of protocols and other study and regulatory-related documents for DCR-PHXC, and other programs.
- Participate in the analysis and interpretation of data, ensure integrity of trial data, and assist in reporting of study results including preparation of scientific summaries, abstracts and manuscripts.
- Provide leadership in the execution of clinical trials.
- Ensure compliance with SOPs, ICH, GCP and other national and international regulatory requirements.
- Work with the VP Medical/Scientific Development, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams to deliver and drive the timely completion of all clinical activities related to DCR-PHXC and other emerging clinical-stage programs.
- Serve as a leading member, or participant, at multiple internal review groups and utilize novel and creative methods to resolve clinical development problems.
- Work with the larger Global Project Team to deliver excellent medical support for DCR-PHXC and other clinical-stage programs.
- Interface with US/international regulatory authorities, as appropriate, in support of the development objectives for DCR-PHXC and assist Regulatory Strategy staff in the compilation of submissions and in the responses to inquiries.
- Lend clinical expertise to the Statistical Analysis Plan development and data management, and work closely with statistical programming and data management on the project level.
- Act as a liaison between the company and clinical site investigators and KOLs.
- Interface together with VP Medical/Scientific Development with Safety Review Committees and Data Safety Monitoring Committees.
- Participate in safety review meetings and providing medical monitoring of ongoing clinical trials.
- MD or the international equivalent is required.
- Strong scientific background with experience in reviewing & interpreting scientific and study data is required.
- Track record of scientific publications strongly preferred.
- 1+ years Pharmaceutical/Biotech industry experience, including time managing clinical trials, or academic clinical research background.
- Working knowledge of biostatistics, data management, clinical operations and scientific and technical processes desirable.
- Working knowledge of applicable US and EU regulatory requirements and of the drug development process.
- Experience in building and maintaining effective relationships with external KOL’s, advisory boards and other key external therapeutic area influencers desirable.
- Team player who works collaboratively in a challenging team matrix environment.
- Ability to work independently to resolve challenges and conflicts.
- Excellent written and oral communication skills.
- Integrity, honesty and highest ethical standards and a sense of personal accountability.