Head of Clinical Development

Part Time

New York City, New York, United States

Job description

Scismic is supporting the growth of a biopharmaceutical company based in New York City creating breakthrough oncology medicines. They are a venture-backed company with top institutional investors affiliated with leading academic institutions in New York City.

We are seeking an experienced, part-time Head of Clinical Development who will provide strategic and tactical medical leadership and oversight of clinical trials in oncology.  This position will serve as the clinical advisor and for multiple oncology products as they move through discovery into development.  This individual will be accountable for advising on the early development strategy and clinical execution of a small molecules for oncology indications. This position will also support execution of multiple planned phase 1 and phase 2 studies and play a role in fundraising. This individual must have the ability to work in a fast-paced, team-oriented, start-up environment to drive strategic planning as well as integration with discovery activities. The successful candidate will liaison with senior management and the discovery team. 


Responsibilities:

  • Plan clinical development strategy for multiple small molecule discovery programs in collaboration with senior management
  • Serve as internal and external project champion through interactions with our senior leadership, our board of directors, clinical experts, steering committees, and patient groups
  • Be primary clinical author on key clinical-regulatory documents including study protocols, investigator brochures, general investigational plans, annual safety reports, regulatory briefing packages, PINDs, INDs, and NDAs
  • Serve as medical monitor for early development studies, and support medical oversight of other assets 
  • Identify, select and oversee vendors, CROs to support clinical program needs. 
  • Identify, select and build strong professional relationships with study investigators
  • Interact with patient advocacy groups and community engagement leaders to build awareness and enthusiasm for our pipeline assets
  • Oversee pharmacovigilance activities across pipeline
  • Over time, build, mentor, and manage a clinical team of medical directors to support our company's pipeline including a broad range of therapeutic indications and modalities
  • Develop and integrate timelines and budgets for nonclinical and clinical activities with overall company timelines and goals, in close coordination with project management, CMC, nonclinical development, regulatory affairs, and other stakeholders
  • Collaborate closely with key cross-functional colleagues to insure seamless integration of preclinical, nonclinical and clinical activities.      These would include identifying nonclinical risks, differentiation strategies, and developing risk mitigation plans.
  • Identify nonclinical risks to our programs and develop risk mitigation plans
  • Contribute to the development and maintenance of a positive team-focused company culture and champion our values through sharp and thoughtful leadership
 

Requirements:

  • MD with a minimum of 10+ years of relevant industry experience
  • Strong leadership and communication skills to translate corporate objectives into action plans that effectively and consistently deliver high quality data on time and on budget
  • Track record of early development leadership on multiple programs resulting in important go/no go decision-making
  • Experience in biomarker development is desired
  • Ability to adapt quickly to changing environments and priorities
  • Experience with the preparation and submission of study protocols, statistical analysis plans, Investigator Brochures, and other regulatory documents (PIND, IND submissions)
  • Experience in the oversight of early-stage and/or registration-enabling clinical global clinical development programs including CRO, site, and vendor selection and relationship building with investigators/site study staff, advocacy groups, and other third parties
  • Direct experience setting patient advocacy strategy and leading successful interactions with patient advocacy groups and patient leaders
  • Ability to travel domestically and internationally for vendor visits, industry conferences, regulatory meetings, advisory board, and other ad hoc meetings as required
  • Positive and enthusiastic disposition and high personal and ethical standards in approaching corporate goals
  • Management experience, particularly in areas of team building, professional development, and mentorship of more junior staff is desired

Welcome! The company you're applying to uses Scismic to screen candidates.
Create an account and upload your resume to start your application.

Why should you use Scismic?

Save time
Our matching algorithm shortlists the roles you qualify for to save time in your job search for FREE.
Better results
You're 5x more likely to be called back by the hiring company when you apply on Scismic.
Personalized help
Access free career resources and guidance from our team of scientists. Reach out at [email protected]
We currently accept PDF Or Doc files smaller than 5MB.
Already have a Scismic account? Log In
Your session has expired! Click OK to reload the page.
Are you sure you want to DEACTIVATE your account?