Our client is a clinical-stage biopharmaceutical company developing novel therapeutic compounds. They have asked us to assist them in their search for a Vice President, Clinical Development .
Major tasks and responsibilities will include:
Builds and organizes the clinical development team.
Designs and implements the clinical development strategy and clinical protocols.
Delivers high quality clinical programs, from first-in-human trials, through to full development (Phase 3 and potentially Phase 3b/4).
Serves as the medical lead for clinical stage programs.
Oversees all medical aspects of the operational conduct of clinical studies (e.g. safety/benefit risk determination, protocol deviation review, clinical quality, etc.), partnering closely with heads of clinical operations, pharmacovigilance, clinical quality, and biometrics.
Provides medical leadership for key areas of clinical operational strategy, particularly with respect to site selection, enrollment, feasibility, etc.
Serves as the primary, point of escalation for all issues identified which may affect the quality and integrity of clinical studies.
Represents the company to all external stakeholders supporting the conduct of clinical trials, including CROs, clinical consultants, investigational sites, etc.
Responsible for the medical integrity of clinical study reports and data interpretation/communication.
Represents the company at regulatory meetings including presentation at Advisory Committee Meetings.
Actively participates with the corporate leadership team on the strategic direction of business and provide guidance on opportunities/hurdles that may be forecasted.
Supports business development, potential product evaluation, and due diligence.
Supports medical affairs by providing commercial and post-marketing insight to ensure effective clinical trial design and data generation.
Participates in developing the strategy for filings outside the US.
Develops and manages budgets required to implement clinical development plans, and regularly report plan progress to stakeholders.
Provides medical/clinical expertise to internal (Marketing, Sales, Manufacturing, Managed Care, Regulatory Affairs, R&D, and Legal) and external (healthcare professionals, data safety monitoring boards, patients, advocacy groups, etc.) customers.
Works with Corporate Affairs Group to foster patient advocacy group relationships.
Leads and conducts the performance management and merit process throughout the year for the clinical development team; this includes assuring clinical development employees are properly managed, qualified, and trained to perform their jobs effectively.
Coaches, manages, and mentors direct reports while providing job enrichment and developmental opportunities.
Assures timely goal and individual development plan setting.
We seek candidates with the following qualifications:
Requires an MD, DO, or foreign equivalent.
Must have a minimum of 5 years of management experience in the pharmaceutical industry within medical affairs, clinical development, or equivalent.
Sub-specialization training or industry experience in hematology, nephrology, ophthalmology, or rare/orphan diseases highly preferred.
Experience thriving in a small/entrepreneurial setting is highly preferred.
Must be a team player with strong negotiation, problem-solving, and strategic influencing skills.
Highly developed written and verbal communication skills required. Including the ability to effectively articulate highly technical/complex scientific data and concepts to audiences with differing scientific and technical knowledge.
Requires the proven ability to perform successfully under stringent timelines and with changing and competing priorities.
If interested, please email your resume as a Word attachment to us, reference 3951. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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