Director/Head of Clinical Development - OliX Pharmaceuticals, Inc.

CMO/Head of Clinical Development

Position Summary

OliX US, a leading global RNAi therapeutics company with multiple programs in development pipelines, is seeking a highly motivated and passionate Chief Medical Officer (CMO)/Head of Clinical Development to join our expanding drug development team in Cambridge, MA. The candidate will provide clinical leadership, including strategic development, protocol design, protocol execution and data analysis. The CMO will also be engaging the overall R&D strategy of the company and is expected to build strong relationships with key opinion leaders (KOLs) as well as members of broader medical and scientific communities. The ideal candidate should possess the ability to multitask and to function effectively in a fast-paced environment. 

Key Responsibilities

· Provide clinical and scientific input into new studies, starting from early concept generation and extending through protocol development and execution of clinical trials.

· Manage all clinical development activities from pre-IND through full development.

Conduct medical review, assessment and interpretation of all clinical data reported in clinical study reports to ensure that the data are presented with the appropriate medical interpretation

· Lead a high performing clinical team

Facilitate a seamless transition between research and clinical development by collaborating with the nonclinical teams to shape and define the development strategy for early assets.

· Stay informed about competitors and clinical developments in relevant therapeutic areas by attending scientific meetings, building relationships with key opinion leaders (KOLs), and tracking relevant literature.

· Prepare clinical sections of regulatory submissions and act as the clinical representative at regulatory authorities as needed.

• Support in-licensing and out-licensing activities, as well as partner relationships
• Prepare verbal and written summaries of study data and outcomes for internal discussions

· Liaise with cross-functional teams (Pharmacology, CMC, Nonclinical, Regulatory etc.)

· Build strong collaborative relationships with discovery teams on the design of non-GLP investigative and pharmacology studies to support development compounds

· Perform other duties as assigned

Requirements

· PhD or MD (preferred)

· Minimum 15 years of experience in clinical development

· In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale

· Experience in preparing IND & NDA/BLA applications preferred.

· Knowledge of Good Clinical Practices (GCP) and regulations and guidelines from FDA and EMEA/CHMP, as well as other applicable international regulatory requirements

· Proven ability to solve problems while demonstrating superior judgement and a balanced, realistic understanding of issues

· Strong communication and presentation skills, with the ability to work both independently and collaboratively