What are the responsibilities and job description for the Director/Head of Clinical Development position at 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
Keep a pulse on the job market with advanced job matching technology.
If your compensation planning software is too rigid to deploy winning incentive strategies, it’s time to find an adaptable solution.
Compensation Planning
Enhance your organization's compensation strategy with salary data sets that HR and team managers can use to pay your staff right.
Surveys & Data Sets
What is the career path for a Director/Head of Clinical Development?
Sign up to receive alerts about other jobs on the Director/Head of Clinical Development career path by checking the boxes next to the positions that interest you.
