Clinical Scientist/Senior Clinical Scientist

Location
Redwood City, CA
Posted
May 18, 2021
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
Our Clinical Development Team is looking to bring onboard a Sr. Clinical Scientist. This individual will be responsible for implementation, planning, and execution of assigned clinical trial activities, serves as Clinical Trial Lead for one or more trials, successfully leads, plans, and executes trial level activities for multiple trials with minimal to moderate level of supervision, provides scientific and clinical leadership to team of supporting Clinical Scientists (matrix leadership), co-Leads study team meetings in partnership with clinical operations; and collaborate with cross functional study team members. This position may support clinical development planning (collaboration with Clinical Development Lead/Clinical Trial Physician for provision and analysis of data to support future planning).
What you'll do:
  • Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team members
  • Plan and lead the implementation all study startup/conduct/close-out activities as applicable
  • Evaluate innovative trial designs (collaboration with Medical Monitor/Clinical Development Lead)
  • Protocol and ICF development process with minimal guidance; including writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality (collaboration with Medical Writing)
  • Site-facing activities such as site initiation visits, on-going training and serving as primary contact for clinical questions
  • Activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review by supporting CS team
  • Clinical data trend identification; provide trends and escalate questions to Medical Monitor
  • Develop clinical narrative plan; review clinical narratives
  • Provision of information required by Protocol Manager for development of trial budget, CRO scope of work, etc.
  • Review development of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., DMC) activities
  • Drafting/review and validation of clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses)
  • Collaborate and serve as primary liaison between external partners for scientific advice
  • Assist in additional functions as needed.

About you:
  • Degree in Life Sciences (MD, PhD, OD, Pharm D, MS, RN or other scientific field preferred)
  • Clinical Scientist experience: 5-7+ years of experience in clinical science, clinical research, or equivalent
  • Senior Clinical Scientist experience: 8 – 10+ years of experience in clinical science, clinical research, or equivalent
  • Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
  • Proficient knowledge and skills to support program specific data review, trend identification, data interpretation
  • Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
  • Excellent verbal, written, communication and interpersonal skills
  • Must be able to effectively communicate and collaborate across functions and job levels
  • Ability to assimilate technical information quickly
  • Routinely takes initiative
  • Detail-oriented
  • Strong sense of teamwork; ability to lead team activities
  • Proficient in Medical Terminology and medical writing skills
  • Proficient knowledge of the disease area(s), KOLs, indication(s), compound(s) under study (including MOA, PK/PD, biomarker & safety profile)
  • Proficient critical thinking, problem solving, decision making skills
  • Understanding of functional and cross-functional relationships
  • Commitment to Quality
  • Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism
  • Proficient planning/project management skills (ability to develop short to mid-range plans that are realistic and effective in meeting goals)
  • Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review or similar data reporting tools

About Us
Adverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.

At Adverum, Inclusion and Diversity are at our core. We believe in the power of being your authentic self.  We strive to create the space which allows for everyone in our Adverum Community to not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation