Job Scope & Purpose:
Our clinical-stage pharmaceutical start-up developing advanced drug-aerosol therapeutics and backed by a top-tier group of investors has an amazing opportunity for a Chief Medical Officer. The company’s lead drug development program is aiming to provide a first-in-class therapy against a lethal orphan respiratory disease mainly affecting lung transplant patients. After promising early clinical results, it’s currently preparing Phase III studies in the US and Europe.
The Role: You will be responsible for leading the clinical development and, as part of the senior management team reporting to the CEO, responsible for formulating overall company strategy and executing on it. In this role, you will be the clinical face of the company, driving interactions with clinicians and KOLs, pharmaceutical and biotechnological partners, the FDA as well as investors. You will lead efforts to clinically validate and expand their proprietary platform and help to establish new programs to be developed internally and in conjunction with other partners.
Create and guide clinical strategies for drug development, including:
Direct supervision and execution of lead Phase III clinical program in US and EU
Direct supervision of FDA/EMA study protocol approval
Interact with FDA and other WW regulatory authorities
Execute, supervise and monitor trial conduct, patient recruitment as well as work closely with external medical monitors to assure consistency of conduct across trials. Work closely with all functions of the organization and external partners to manage trial logistics
Promotion of program towards KOLs and strategic partners
Contribute to corporate strategy through evaluation and planning of second drug development program targeting respiratory end-stage disease with high unmet medical need
Follow important developments and relevant trends in the scientific literature and develop/maintain contacts with external experts to support understanding of the candidate drug effects and to gain strategic insights into further development
Develop effective relationships with external providers to ensure successful medical oversight of outsourced studies
Support qualification of pharmacodynamic/disease markers for assessment of efficacy
Work closely with the project management representative(s) to track trial status
Work closely with study physicians, as well as other project team members / functional areas to ensure regulatory compliance
Write and provide editorial comments for clinical protocols, study reports and manuscripts
Responsible for the scientific quality of all clinical work
Ensure consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations and laws
Primary Job Requirements:
MD or MD/PhD with minimum 8-10 years drug development experience
Experience in respiratory disease is required, with a preference for some exposure to inhaled and/or orphan products as well as autoimmune/inflammatory indications
Experience in all stages of drug development, spanning IND filing through to regulatory approval, is essential. Later stage drug development experience is especially important and experience with commercial products and market access procedures is a plus.
Proven track record of FDA and EMA drug approval
Ability and willingness to travel approximately 30% within the US (visiting US study centers, KOL management and FDA hearings) and to EU (management and board meetings, visiting EU study centers, KOL management and EMA hearings).
Proven track record of building and leading a clinical team and experience as a hands-on leader in a small company setting is important as it relates to the following responsibilities:
Management of resources and timelines
Direct involvement in authoring protocols and regulatory filings
Selection and management of partners for outsourcing
Innovative thinker with passion and commitment to drive operational execution
Ability to proactively identify and resolve issues
Excellent communication (verbal, written, presentation) and interpersonal skills; ability to effectively translate information and facilitate agreement across diverse groups
Self-starter and team player with a strong results orientation
Strong organizational and analytical skills; ability to understand and interpret scientific research
Ability to flexibly adapt to changing business needs
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
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