Who We Are:
We are an integrated genetic medicines company developing targeted, disease-modifying medicines for patients with life-limiting respiratory diseases. Our treatments address the underlying genetic cause in underserved populations and have the potential to tremendously impact the quality and length of patients’ lives.
At ReCode, we bring a unique blend of rigor, creativity, and curiosity to our high-hurdle mission: harnessing our multi-platform approach to develop disease-modifying medicines. Our team is uniquely positioned to tackle this challenge, given our extensive experience in RNA delivery technologies, protein structure, tRNA biology, mRNA manufacturing, gene editing, and drug development.
Summary of Position: (Menlo Park, CA or Remote (NJ, NY, PA tristate area)
The Director/Senior Director, clinical scientist will report to the Senior Vice President, Clinical Development. You are a scientific leader that will be a major contributor to the design, implementation, and analyses of ReCode’s critical clinical development programs. As someone with an eye for detail and an expert in clinical data sciences you will drive strategy and thinking across all aspects of ReCode’s rare diseases programs from concept to analysis and interpretation. With experience in clinical biomarkers and/or rare diseases your contributions will be critical to deliver on ReCode’s mission of powering the next wave of genetic medicines.
We are seeking a highly detail oriented, senior clinical scientist with a passion for rare diseases and drug development. You will have extensive experience in the biopharmaceutical industry working on rare disease clinical programs with experience in early clinical development. Critically you will have a sound understanding of data sciences. You will have experience supporting clinical studies and working with a team of physicians and clinical operations executives. Ideally you will also have experience or specialism in one or more of the following areas: Clinical biomarkers, pulmonary drug development, cystic fibrosis. This position report to the SVP of clinical development.
- Participates in the development of Study Protocols, Investigator's Brochures, Clinical Development Plans and other key study documents (medical monitoring plans, statistical analysis plans, data management plan, eCRF completion guidelines, data validation manuals, database UAT, ICFs etc.,)
- In conjunction with other line functions; provide strategic and scientific leadership for trial designs, both standard and novel for rare disease indications
- Serves on cross-functional study teams for assigned trials, working with other team members to achieve efficient, high-quality study execution
- Draft and/or review regulatory documents in support of regulatory submissions, for study opening and execution including clinical section of IND’s and CTA’s, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate
- Acts as liaison between Clinical Development and other internal groups at ReCode (e.g., Regulatory Affairs, Clinical Development Execution) for assigned studies
- May interact with external thought leaders, including advisory boards, to support clinical and translational development
- May prepare or participate in literature reviews and publications as appropriate
- Trains and support study team and CRO personnel regarding clinical aspects of trial
- Accountable to the Clinical Lead for the project for a specific trial to support first-line, raising and responding to investigator queries, writing safety narratives, analysis of trends of safety and efficacy, etc.
- Coordinates and maintains and develops relationship with key study investigators, organizes steering committees, advisory boards, and data safety monitoring boards as required
- Identifies program, trial or data risks, creates and implements mitigation strategies
- Works with clinical operations to enable compliance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety.
- Responsible, with input from Medical Monitors, Clinical Trial Management Biostatistics and Data Management for timely clinical data review and quality of deliverables.
- Reports to supervisor and management on clinical trial findings and milestones
- Review scientific literature and develop product and indication knowledge to understand and effectively communicate information relating to products, product candidates and therapeutic areas.
- Maintain a high degree of awareness of the external research and regulatory environments and track emerging study data to ensure appropriateness of clinical development plans and trial endpoints.
- Participate in the review and interpretation of clinical trial data and provide insight into the clinical relevance of trial results.
- Provide analyses of development strategies and options for ReCode’s pipeline programs, including input into Proof-of-Concept trials, biomarker approaches, etc.
- PhD scientists with 5 + years of experience in clinical research and development (Candidate’s with an MS and substantial experience maybe considered)
- Small company experience desirable
- Strong clinical data sciences background required. Expert in analysis and interpretation of clinical data (safety and efficacy); in-depth knowledge of biostatistics, GCP, and regulatory requirements for clinical studies.
- Demonstrated ability to make independent, timely and appropriate decisions.
- Excellent oral and written communication skills to communicate complex concepts and solid computer/analytical skills.
- Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate.
- Advanced level of organizational and project management skills.
- Flexibility to accommodate changes in team and project needs
- Ability to handle multiple projects at a time and have a strong attention to detail while understanding the higher-level strategy.
ReCode Therapeutics (www.recodetx.com) offers a competitive compensation/benefits package with a friendly, collaborative culture that values employee engagement and ongoing career development.
ReCode Therapeutics is an Equal Opportunity Employer.