Due to rapid growth our client, a publicly listed clinical-stage Biotech company, now have approval to hire a VP Clinical Development who will provide leadership of the company’s study programmes, early and late-stage clinical development including study design and operational management of Neuroscience registrational studies.
The successful candidate will define Clinical Development strategy and associated Clinical Development plan, building infrastructure and teams for reporting groups (as Clinical Science, Clinical Operations, etc.) and driving clinical study programmes towards execution.
This role requires a highly qualified candidate (M.D. and/or PhD) with proven Clinical Development experience in leading a global study programme from early stages through Pivotal trials and NDA application process to regulatory approvals (FDA, EMA, etc.).
This hire will be an inspiring leader; with excellent management, communication and influencing skills, who has exhibited true resilience through NDA approvals process. Demonstrable experience is required.
Responsibilities of VP Clinical Development:
Key role activities will include:
• Lead the design and execution of the company’s clinical studies and development plans while meeting standards of excellence for ethics, scientific merit and regulatory compliance. This includes protocol design, outsourcing partner management, oversight of operational activities, results interpretation and reporting.
Executing for Results
• Hands-on leadership role of the Clinical Development function and activities (in-house and outsourced) aiming at developing the company’s products and evaluating the efficacy and safety of drug candidates in human studies, working closely with Regulatory Affairs, CMC, Nonclinical, and other functions.
Relationships and Influence
• Play a lead role in developing the company’s KOL network and building support for the clinical programme.
• Represent the company as needed as a senior medical spokesperson to a variety of scientific, business, investor and government groups/agencies.
• Represent the company’s brand and competitive advantages in the most constructive scientific way to decision influencers.
Requirements for VP Clinical Development
• MD or PhD qualification with proven academic excellence.
• A track record that includes early and late-stage clinical development including study design and operational management of registrational studies, preferable withing Neuroscience.
• Regulatory experience, including up-to-date knowledge in current regulatory processes and rules.
• Hands-on leadership style and a preference for staying close to clinical execution while also being able to bring a strategic perspective.
• Experience in the management of outsourced development programmes.
• Track record of success in building and leading a KOL network internationally.
• A blend of conventional pharma plus biotech experience and the attitude and ability to be effective in a lean, small company environment.
• Experience in operating at executive team level and in working and influencing cross-functionally.
• Proven aptitude in continuously developing own scientific and medical knowledge. Strong analytic capability.
• Flexible, able to adjust, embrace and drive change.
• An established network of Neuroscience KOLs and credibility with this group.
• Experience with commercial stage drugs.
• Ideally a track record of interacting with investors.
For further details please contact Larry on +353 1-2302400 / email@example.com
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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