Head/VP Clinical Development

Location
98119, Seattle
Posted
Jun 14, 2018
Hotbed
BioForest
Required Education
Doctorate/PHD/MD
Position Type
Full time

Head / VP of Clinical Development

Primary Function

Responsible for the clinical development of all Alpine Immune Sciences (AIS) therapeutic programs, including all relevant functions – such as clinical affairs, operations, and biometrics. Works closely with key internal and external stakeholders to enable the rapid and efficient assessment of clinical assets in first-in-human and proof-of-concept studies, progressing through pivotal registration studies and into lifecycle.

Key Responsibilities

·       Develop and implement comprehensive, cross-functional Therapeutic Product Profiles and Product Development Plans, as appropriate based on a given asset’s unique attributes, including appropriate input from stakeholders within clinical development, CMC, regulatory, IP and commercial.

·       Design and implement comprehensive clinical development plans incorporating appropriate clinical studies with sufficient size and scope to enable efficient, confident milestone decisions (phase I to registration studies, including proof of mechanism, proof of concept and transition to lifecycle)

·       Key responsibility for clinical portfolio and program strategy including recommendations regarding ‘go/no-go’ decisions related to further development of assets

·       Responsible for clinical study medical monitoring, data review, analysis, and interpretation, which will include the completion of CSRs and appropriate regulatory submissions.

·       May build or contribute to the build of cross-functional areas within clinical development, including but not necessarily limited to clinical pharmacology/toxicology, and companion diagnostics/biomarkers.

·       Manages and mentors all aspects of clinical science

·       Organizes scientific and clinical advisory board meetings as needed.

·       Proposes, evaluates and selects clinical vendors and consultants as appropriate

·       Ensures corporate compliance and GCP

Requirements

·       MD degree with board-certification or eligibility (or equivalent) in medical oncology, hematology, rheumatology, or other immunologically-relevant discipline

·       10+ years of experience within the pharmaceutical/biotechnology industry, with proven ability to manage effectively meaningful teams

·       Proven success with development of oncology and/or immunology clinical assets. BLA/MA experience strongly preferred.

·       Highly advanced knowledge of clinical development process

·       Strong knowledge of ICH, GCP, and FDA, EMEA, and Asian regulatory requirements

·       Ability to operate successfully (develop strategy, execute on plans, achieve goals, make decisions, hire and mentor team) in fast-paced, start-up environment

·       Excellent communication and leadership skills