Chief Medical Officer
Our client is a clinical-stage biotechnology company. They have asked us to assist them in a search for a Chief Medical Officer.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Works with other members of the executive team, leads company strategy development and drives company strategic decisions.
- Actively engages and drives business development opportunities.
- Acts as a visible leader within company’s biotech ecosystem.
- Addresses relevant questions to clinical domain within investor relationships.
- Regularly interacts with board on strategic issues.
- Builds external relationships that benefit the company.
- Drives cross-functional alignment based on strong collaboration across company.
- Drives internal and external collaboration by continually seeking and implementing innovative solutions; creates a culture that thrives on progress and results; inspires people to stretch beyond their comfort zone.
- Leads clinical development strategy.
- Leads and drives the strategic definition and tactical development of all clinical trial strategy and programs across phases I through III.
- Collaborates with colleagues in discovery research and preclinical development line functions to move product candidates forward into clinical investigations.
- Serves as the clinical lead for advisory meetings.
- Ensures timely medical review and reporting of adverse events.
- Provides clinical guidance, support, and education to external organizations.
- Ensures the timely preparation of presentations reporting results of clinical trials to internal and external audiences.
- Builds a high performing clinical team including the ability to lead clinical development, operations, regulatory, medical and safety functions over time.
- Inspires, coaches, mentors, and develops broad clinical team, and across the company.
- Provides the highest level of leadership and internal engagement across all team members and potential talent.
- Effectively manages annual operating plan for clinical team to ensure all deliver against goals and priorities.
- Ensures that all clinical trials are in keeping with approved timelines and budgets, with potential obstacles identified and solutions implemented to avoid delays in clinical trial implementation.
- Represents the clinical line function on multidisciplinary project teams.
- Assists Regulatory Affairs to ensure the timely preparation of documents to be submitted to the FDA and other health authorities for review.
- A medical degree or PhD is required.
- Metabolic or immunology training or experience is preferred.
- Experience in pharmaceutical or biotech industry with extensive experience in clinical development required; emphasis on Phases I through III development.
- Must have experience in pharmaceutical or biotech industry with extensive experience in Phases I through III clinical development.
- Requires the ability to work in a small startup environment and interact across multiple disciplines. Prior experience within a small-company environment is preferred.
- Requires the proven ability to lead and develop an overall clinical development strategy. Must bring innovation to clinical development strategy of a novel platform.
- Comprehensive understanding of clinical regulatory requirements and knowledge of all relevant guidelines is required.
- Must be familiar with ICH guidelines and FDA requirements.
- Must have a working knowledge of biostatistics as relevant to the design and analysis of clinical trials.
- Prior experience at senior levels working in or leading cross-functional teams is required.
- Must be a team player with executive presence and demeanor.
- Excellent written and verbal communication skills and outstanding analytical abilities are required.
- Must be comfortable working both internally and externally with technical and medical experts.
- Must be an independent, self-motivated individual with a highly entrepreneurial style coupled with self-confidence and a positive management style.
- Must be a strategic and innovative thinker with proven ability to communicate a vision while also able to drive results.
- Demonstrated management, organizational and interpersonal skills are required.
- The ability to solve problems and execute on initiatives is required.
- Must have the ability to work collaboratively internally and externally.
- Must be self-assured and results oriented.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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