Head of Clinical Development, Cardiology
Our client is a biotechnology company. They have asked us to assist them in a search for a Head of Clinical Development, Cardiology.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Establishes clear project plans and leads the day-to-day clinical development activities to efficiently achieve critical clinical development milestones.
- Applies knowledge of clinical development and project management to guide the creation and execution of an overall product development plan for assigned clinical asset(s).
- Provides medical oversight and strategic leadership to advance the clinical portfolio.
- Directs the clinical development strategy for key assets with an enterprise mindset.
- Leads and provides oversight to a cross-functional study team.
- Manages and directs team leads (e.g., clinical development, CMC, regulatory, commercial) to create product development and lifecycle management plans that optimize value, time, resources, and risk.
- Serves as medical lead for clinical stage programs, overseeing all medical aspects of the conduct of clinical studies.
- Plays a key role in advancing corporate vision, strategy, and culture to execute mission critical goals in collaboration with the Chief Medical Officer. Executes on these objectives in a highly cohesive manner.
- Optimizes clinical study designs to align with regulatory strategy.
- Drives scenario planning for clinical development to support decision analysis and optimize resource allocation.
- Contributes to publication strategy and content of individual publications, abstracts, and presentations.
- Contributes to clinical development strategies as needed to support action-based studies or exploration of new indications.
- Maintains up-to-date knowledge of scientific and clinical published literature.
- Oversees the evaluation of safety, pharmacology, and efficacy data from ongoing and completed studies.
- Serves as a medical resource for design and interpretation of clinical and preclinical programs to support existing and new development candidates. Provides clinical input to support ongoing business development initiatives.
- Contributes to the development and maintenance of a positive, collaborative, team-focused company culture.
- A Medical degree or equivalent is required.
- Strong preference for sub-specialty training in cardiology.
- A significant track record in a pharmaceutical or biotech company is required.
- Must have a thorough understanding of early clinical development.
- Requires demonstrated excellence and experience in clinical development including the design, execution of clinical trials, and the writing/submission of INDs.
- The ability to work across multiple disciplines and prior experience working in a small-company environment is preferred.
- Must have strategic awareness to prioritize product development programs to achieve business goals.
- Must have proven experience in contributing to the overall strategic direction of an R&D portfolio.
- Requires experience managing all aspects of a multicenter clinical study from inception to completion.
- Must have an in-depth understanding of FDA regulations and ICH/CGP guidelines.
- Must have a strong leadership presence and the ability to work effectively with other functions.
- Requires a passion for fostering a positive and productive organizational culture and must be committed to engendering credibility and confidence within and outside the company.
- Must be comfortable in a small organization where all leaders take a hands-on approach in a rapidly changing environment.
- Must have a patient-centric mindset.
- Requires excellent verbal and written communication skills with the ability to articulate ideas to different audiences.
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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