Associate Director/Director, Clinical Research

Company: Dicerna Pharmaceuticals, Inc.
Location: Cambridge
Posted on: January 16, 2022

Job Description:

We are seeking an enthusiastic Clinical Scientist with a high degree of scientific acumen who is excited by cutting-edge biotechnology and wishes to take part in the unique opportunity to develop highly innovative pharmaceutical products for the treatment of rare diseases. The candidate is a team player, detail oriented with prior research experience in industry.

In this role, the incumbent will report to the Vice President, Early Stage Clinical Development & Clinical Research and help develop Dicerna's clinical programs. In doing so, the Associate Director/Director Clinical Research will lead an interdisciplinary team to support the development of novel clinically meaningful surrogate endpoints and serve as a scientific resource to cross-functional internal teams to facilitate study execution.

Key Responsibilities

Leads interdisciplinary clinical research team focused on the development of novel clinically meaningful surrogate endpoints and helps in the execution of clinical trials

Utilizes scientific knowledge for the design of bioanalytical methods and algorithms to quantify the effect of RNAi on specific disease states

Collaborates with VP, Early Stage Clinical Development & Clinical Research to ensure scientific and data integrity, including quantitative aspects of the clinical trials, study safety, and data-driven decision criteria

Manages key stakeholders for biomarker development, qualification and validation of analytical methods and endpoints for clinical trials.

Serves as expert on scientific issues for rare disease program

Participates in the selection of contractors/ vendors supporting early stage clinical development activities and managing their activities.

Liaise with external investigators for outsourcing of selected clinical research activities and sample procurement

Serve as a scientific resource to cross-functional internal teams to facilitate quality of study execution and problem resolution.

Supports the VP Early Stage Clin. Dev. And Clin Research in managing budgets for clinical research activities

Provide relevant scientific expertise to internal teams, including clinical operations and medical writing to ensure quality processes and deliverables

Support development of clinical studies and reviews clinical protocols and clinical study reports for scientific accuracy.

Contribute to authorship of clinical trial protocols, protocol amendments, IBs, publications and presentations, and regulatory filings including IND, briefing books and responses to questions from regulatory agencies

Review of scientific and medical literature relevant to product therapeutic areas.

Participate in development and continuous improvement of processes and workflows

Performs literature searches and coordinates scientific discussions relevant for designing study protocols, interacting efficiently with internal/external collaborators to ensure the trial design is in line with current regulatory and scientific requirements

Participates in the monitoring and interpreting of data from an overall scientific standpoint, assessing the scientific implications and making recommendations that can impact clinical development

Support, and/or participates in clinical/medical advisory panels, steering committees and investigator meetings.

Support of the Dicerna Medical Monitor in the review, analysis and reporting of clinical trial data as well as co-authoring, development and review of clinical study documents, reports, etc

Qualifications

PhD degree in life sciences

Clinical research experience, preferably in academia and industry with a minimum of 5+ years Pharmaceutical/Biotech industry experience desired

Team player who works collaboratively in a challenging team matrix environment

Relevant experience in bioanalytical assay development such as LCMS, ELISAs, and Immunohistochemistry

Knowledge and understanding of GCP, GLP, ICH guidelines and the regulatory landscape in the United States, Canada and Europe preferred

Excellent writing and communication skills

Must be adaptable and enjoy working in a fast-paced environment.

Attentive to details; good initiative and able to work collaboratively in dynamic small teams of internal and external partners under tight timelines

Track record of scientific publications preferred

Integrity, honesty and highest ethical standards and a sense of personal accountability

Keywords: Dicerna Pharmaceuticals, Inc., Cambridge , Associate Director/Director, Clinical Research, Healthcare , Cambridge, Massachusetts