The role is responsible for the development of clinical research strategies and direction of Phase 1-3 clinical studies while working with cross-functional project teams. S/he will be responsible for study design, development, data readout, and summary. This position will also provide ongoing input into assessment and interpretation of safety data and contribute to investigator training.
This is not a remote position and is onsite at the San Diego office.
Key Tasks & Responsibilities:
In-depth understanding of the scientific method and clinical applications based on medical, scientific, and practical rationale.
Provide clinical/scientific input to study design, protocol concepts/protocols preparation, statistical analysis plans, and reporting within assigned programs to yield high value clinical endpoint insight for future critical decisions.
Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral form.
Must possess sound scientific and clinical judgement with ability to properly interpret clinical trial data.
Collaborate with external opinion leaders, Principal Investigators, and clinical operations personnel to ensure appropriately designed studies are successfully implemented.
Familiarity with concepts of clinical research and clinical trial design, including biostatistics.
Support the development of key scientific relationships with external opinion leaders and make scientific presentations at advisory boards, key scientific meetings and external committee meetings.
May serve as Medical Monitor responsible for the safety monitoring of clinical trials, and as the medical expert for clinical studies.
Participate in preparation of abstracts, manuscripts, and presentations for external meetings as well as author clinical sections of regulatory documents (IB, IND sections).
Conduct medical assessment and disposition of adverse events (in conjunction with Drug Safety Physician) and evaluate safety of clinical compounds prior to and during ongoing clinical studies.
Provide periodic status updates and effectively communicate with Senior Management Team.
Support the development of regulatory documents for filings and agency meetings and participate in interactions with regulatory agencies.
Remains up to date with current information on pharmaceutical regulations, guidelines, and practices, as well as therapeutic area knowledge to ensure consistent best practices across all activities.
Education:
MD degree with accredited residency training and board certification in relevant clinical specialty for the therapeutic area required.
Professional Skills & Experience:
2 to 10 years experience in pharmaceutical and/or biotechnology industry developing investigational new drugs or experience in a clinical research organization involved in clinical trials.
Experience with drug development in metabolic diseases (experience or knowledge of orphan disease drug development a plus).
Ability to analyze and interpret clinical safety and efficacy data and develop written reports and presentations of those data.
Ability to work with a high level of autonomy/independence.
Able to manage priorities and competing demands in a rapidly changing work environment.
Review and interprets scientific knowledge of competitor landscape (molecule / indication).
Proactive identification of issues/problems and recommends solutions.
Knowledge of relevant FDA regulations and guidelines as well as those of the EU and other health authorities; experience with FDA and other health authorities strongly desired.