Medical Director/Senior Medical Director

Full Time

South San Francisco, California, United States

Job description

Scismic is supporting the growth of a biotech company that is translating genetic insights into therapeutic advancements.

We are seeking an experienced Director/Senior Medical Director who will provide strategic and tactical medical leadership and oversight of clinical trials in rare diseases and in genetic subsets of common diseases.  This position will serve as the clinical lead and project team leader of the APOL1 chronic kidney disease program as well as support broader clinical development efforts across the pipeline.  This individual will be accountable for setting the early development strategy and driving clinical execution of a small molecule targeting APOL1, an important genetically defined driver of chronic kidney disease. This position will also support execution of multiple ongoing and planned phase 1 and phase 2 studies of a small molecule against GYS1, a validated target for Pompe disease, and play a role in business development and licensing decisions. This individual must have the ability to work in a fast-paced, team-oriented, start-up environment to oversee all aspects strategic planning as well as oversight of nonclinical activities. The successful candidate will serve in a highly visible, cross-functional leadership role requiring an ability to be a liaison with senior management, functional leaders, and technical leaders in drug discovery, translational science, and clinical development.

The position will report to the Chief Medical Officer and will be a key member of the development leadership team.

Responsibilities:

  • Lead all aspects of the APOL1 project team, taking the development compound through IND enabling studies, first in human studies, and defining the strategy to clinical proof of concept and global registration
  • Serve as medical monitor for the APOL1 early development studies, and support medical oversight of other clinical stage assets within our company, including Phase 1 and Phase 2 studies of a GYS1 inhibitor for Pompe disease
  • Partner with Clinical Development Operations to identify and select study investigators and sites, 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
  • Serve as internal and external project champion through interactions with our senior leadership, our board of directors, academic 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, INDs, and NDAs
  • 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
  • Partner with Clinical Development Operations to identify, select, and oversee vendors and CROs to support program needs
  • Participate in due diligence activities for potential in-license assets and support intelligence activities for competitor assets
  • 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
  • Proactively identify nonclinical risks to our programs and develop risk mitigation plans
  • Collaborate closely with key cross-functional colleagues to ensure preclinical and clinical studies are conducted with the rigor and documentation required to support global marketing approvals
  • 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 5-10+ years of relevant industry experience, including experience as a clinical study medical monitor
  • Board eligibility/certification and clinical experience and/or fellowship in nephrology is highly desired
  • Experience with the preparation and submission of study protocols, INDs, statistical analysis plans, and Investigator Brochures
  • Track record of early development leadership on multiple programs resulting in important go/no go decision-making
  • 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
  • Management experience, particularly in areas of team building, professional development, and mentorship of more junior staff is desired
  • 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
  • Ability to adapt quickly to changing environments and priorities
  • Positive and enthusiastic disposition and high personal and ethical standards in approaching corporate goals
  • Ability to travel domestically and internationally for vendor visits, industry conferences, regulatory meetings, advisory board, and other ad hoc meetings as required

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