Exec. Medical Director, Clinical Development
Description
Our client is a highly attractive clinical-stage biotech company building the next generation of cardiovascular therapeutics with a robust pipeline of first-in-class therapies across all stages of development. As the organization enters a pivotal phase of growth and expansion, this is an exciting opportunity to join a company that is scaling rapidly across the enterprise.
Our client is seeking an industry-experienced Executive Medical Director who will help drive clinical development strategy and execution for a high-profile program, and work alongside exceptional colleagues in an entrepreneurial environment where great science drives decisions, individual contributions matter, and have the opportunity to shape programs, drive innovation for potentially transformative therapies.
Given the fast-paced and evolving nature of a startup biotech environment, the right person is someone who is flexible, creative, comfortable rolling-up-your-sleeves, hands-on, humble, has a passion for advancing cardiovascular medicine, and can thrive in a smaller culture where strategic thinking, scientific rigor and cross-functional leadership drives meaningful impact.
Location
New Jersey
Features
ATTRACTIVE FEATURES ABOUT THIS COMPANY & OPPORTUNITY:
- Opportunity to Truly Impact: A unique opportunity to influence clinical development, work on cutting-edge science, and help bring meaningful 1st-of-its-kind therapies to patients. This is not just another development role – it is a chance to help define a new model for cardiovascular drug development and innovation.
- Enjoy the Best of Both Worlds: Join a successful and financially stable company, while also getting all the pluses of working for a small, entrepreneurial-like organization that is very much in scaleup/growth/building mode and one of the most promising startups in the biotech industry.
- Cutting-Edge Science / New Innovative Medicines: Leveraged by its unique technology, cutting-edge science, and a robust R&D pipeline (including multiple potentially transformative/breakthrough late-stage assets), as well as an integrated platform that has the potential to fundamentally change how cardiovascular medicines are developed, this company is well-positioned for tremendous success and growth.
- Startup Culture: You will be joining at an exciting time and key inflection point in the company’s success journey. Visibility, scientific impact, and the opportunity to shape a program rather than simply manage one.
- Highly Accomplished Executive Leadership: Work closely with an industry experienced and accomplished Senior Leadership team with a proven track record of success in this space.
Responsibilities
RESPONSIBILITIES IN A NUTSHELL:
- Lead the clinical strategy, planning and execution for key aspects of cardiovascular clinical development program.
- Provide clinical/scientific input into the development, design, delivery, and communication of the global evidence generation plan.
- Support cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program.
- Help define the scientific narrative for a novel cardiovascular asset.
- Leads the clinical strategic planning, authoring and review of clinical parts of regulatory submissions and scientific data disclosures of the studies.
- Partner with cross-functional teams to analyze, interpret, and communicate clinical trial data and results.
- Lead the design, authoring, and oversight of clinical protocols, amendments, study reports, and related development documents.
- Provides oversight with the operational aspects of study conduct including site selection and activation, site investigator and staff training, budget planning and contract review.
- Will make scientific presentation at advisory boards, key scientific meetings and external committee meetings.
- Guide interactions with investigators, clinical experts, and global opinion leaders to strengthen program design and execution.
Qualifications / Requirements
DESIRED EXPERIENCE:
- Medical Degree (M.D.) or another health sciences area (e.g. PharmD) is required.
- Minimum 5-7 years of relevant cardiovascular clinical drug development experience working in the pharmaceutical/biotech industry.
- Experience designing and running late-stage development trials (Phase 2b/3) and taking a drug all the way up to NDA submission.
- Proven ability to interpret complex clinical data and translate findings into development strategy.
- Proven ability to work effectively in a fast-paced, startup/entrepreneurial type of environment, to be self-motivated, and to communicate effectively with leadership on-site and internally.
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