Vice President/Head, Clinical Development, Infectious Disease
Our client is a clinical-stage biotechnology company focused on the discovery and development of novel therapeutics they have asked us to assist them in their search for a Vice President/Head, Clinical Development, Infectious Disease
Major tasks and responsibilities will include:
We seek candidates with the following qualifications:
- Develops the company’s pipeline through the design and conduct of clinical development programs for the company’s clinical stage direct lytic agents in close partnership with the Chief Medical Officer (CMO) and Executive Vice President of Research and Development.
- Works closely with the Chief Medical Officer and all relevant functions to ensure medical and scientific excellence and strategic alignment cross functionally.
- Offers a “hands on” approach to the delivery of clinical study programs, partnering closely with the Head of Clinical Development Operations to ensure scientific and executional excellence in all clinical programs.
- Plays a key role in external medical communications related to the company’s novel Infectious Disease portfolio.
- Designs and implements the clinical development strategy and clinical protocols and delivers high quality clinical programs, from first in human trials, through to full development (Phase 3 and potentially Phase 3b/4 programs).
- 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.).
- Partners closely with heads of clinical operations, pharmacovigilance, clinical quality, clinical microbiology and biometrics.
- Provides medical leadership for key areas of clinical operational strategy, particularly with respect to site selection, enrollment, feasibility, etc. and serves as primary, point of escalation for all issues identified which may affect the quality and integrity of clinical studies.
- Has responsibility for the medical content and integrity of clinical study reports and data interpretation/communication.
- Heads medical review of compassionate use/expanded access requests.
- Develops, conducts, plans and executes the Clinical Advisory Boards to inform the planned/potential clinical development trajectory of company’s clinical and discovery stage programs.
- Authors clinical sections of regulatory submissions (INDs, briefing books, BLAs, NDAs, etc.) and represents the company at regulatory meetings including presentation at Advisory Committee Meetings.
- Contributes to the development, chartering and conduct of key clinical oversight and advisory boards, including but not limited to Data Safety Monitoring Boards, Adjudication Committees, etc.
- Represents the company to all external stakeholders supporting the conduct of clinical trials, including CROs, clinical consultants, and investigational sites.
- Engages regularly with external disease area experts, clinical study investigators, regulators, and health technology assessors.
- Seeks opportunities for external collaboration to advance the company's clinical programs.
- Serves as internal infectious disease subject matter expert, guiding development of target product profiles, draft product labeling and responsible for keeping the company updated on new developments in the field.
- Maintains up to date knowledge of the evolving infectious disease medical and therapeutic area landscape and shares this knowledge and insight cross functionally.
- Stays abreast of new developments in the infectious disease therapeutic landscape and regulation which may affect the design and/or conduct of the company's clinical programs and proactively communicates this information internally.
- Proposes, establishes and leads external collaborations to address strategic and tactical needs of agreed Research and Development strategies.
- Authors medical content for and ensures medical accuracy of grant applications, publications (abstracts, manuscripts, oral presentations), regulatory filings and other external communications.
- Provides clinical guidance and/or training to corporate staff.
- Leads medical assessment of pipeline compounds and the evaluation of potential therapeutic utility/indications for pipeline compounds.
- Fosters alignment between Research and Development to ensure appropriate application scientific knowledge to drive strategic, efficient clinical studies to enable accelerated development and decision making.
- Leads clinical aspects of due diligence to support partnership opportunities.
- Serves as member of the Research and Development Leadership Team.
- Presents clinical development strategy to the Science and Technology Committee of the Board of Directors as needed.
- Participates in strategic planning sessions with executive team for the purpose of goal/milestone setting initiatives and design of roadmap to achieve targets.
- Provides medical insight on business development and commercial opportunities and challenges on a global scale.
- Medical degree required.
- Subspecialty training/board certification in infectious disease preferred.
- Must have 10+ years relevant professional work experience in infectious disease (clinical, medical or research) within the pharmaceutical/biotech industry or academic/clinical practice arena.
- 5+ years of experience in pharmaceutical drug development or equivalent experience (e.g. biotech) in infectious disease, antibiotics, virology, or vaccine experience is required.
- Requires demonstrated ability to successfully design, conduct and deliver the results of clinical studies in infectious disease area (experience in antibiotic drug development preferred).
- Must have thorough knowledge of GCP and familiarity with FDA and international regulations as they apply to pharmaceutical drug development.
- Prior experience with regulatory submissions (e.g. IND, NDA, BLA, MAA) and engaging with regulatory authorities is required.
- Matrix leadership and/or direct line management experience preferred
- Must be a resourceful, proactive self-starter with the ability to anticipate potential issues and proactively take measures to defend against them.
- Strong orientation to delivering high quality results is required.
- Requires strategic thinking with a broad perspective of the overall therapeutic area landscape and ability to understand different stakeholders needs and to balance conflicting /diverse priorities.
- Must be an effective and collaborative leader able to manage multi-disciplinary teams directly and/or through influencing others.
- Ability to work in a cross-functional team environment and a flexible team-oriented perspective is required.
- Must possess excellent verbal and written communication skills as well as interpersonal, management, and organizational skills.
- Requires demonstrated problem solving abilities and conflict resolution skills.
- Requires skill at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the organization.
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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