Senior Medical Director

Prestige Scientific - Dallas Area, TX, United States

Senior Medical Director

This senior physician will lead clinical development programs across an impressive portfolio while providing strategic direction, leadership and medical expertise to a growing clinical development team. This influential hire will have the opportunity to provide strategic influence across core development teams. These teams are passionately developing potential treatments across a range of diseases that have few or no treatment options. Therapies in development take advantage of new insights into how genes involved in cellular metabolism and mitochondrial function play a primary role in switching the cellular inflammatory response on and off.

A Uniquely Interesting Opportunity:

  • Growth potential to Vice President.
  • Very innovative team with multiple lead molecules. Data read-outs by end of the year.
  • Lead development compounds are platform technologies, not single molecule for a single disease.
  • Positive data already demonstrated in seven different forms of kidney disease
  • Additional pivotal program underway in polycystic kidney disease
  • Three additional development programs have shown activity and will move into registrational studies.
  • Pivotal program in neurology with biology that is broadly applicable, will launch 3-4 additional major programs with this molecule in other neuromuscular diseases over the next 2 to 4 years.
  • Early development programs with overlapping pharmacology and broad applicability, platform tech.

 

4 PIVOTAL PROGRAMS:

Phase III: Treatment for Friedreich’s Ataxia

  • Just received a very significant positive data read-out for a pivotal study in Friedreich’s ataxia. This compound has the potential to be the first ever approved treatment for Friedreich’s ataxia.
  • Globally enrollment with 103 patients
    • Friedreich’s ataxia: rare genetic disease that causes difficulty walking, a loss of sensation in the arms and legs, impaired speech and damage to parts of your brain, spinal cord and heart.
    • The compound has demonstrated broad activity in numerous neurodegenerative models:
      • Huntington’s Disease
      • ALS
      • Parkinson’s Disease
      • Alzheimer’s Disease
      • Epilepsy

Phase III: Treatment for Alport Syndrome

  • Pivotal Phase 3 fully enrolled with data available in 2H19
  • Alport Syndrome: A genetic condition characterized by kidney disease, hearing loss, and eye abnormalities. People with Alport syndrome experience progressive loss of kidney function.
  • Global enrollment was completed last year with 157 patients.

Phase III: Treatment for Connective Tissue Disease-Associated Pulmonary Arterial Hypertension

  • Phase 3 CATALYST pivotal data available in 1H20
  • CTD-PAH is an often-fatal manifestation of many types of autoimmune disease, including systemic sclerosis (scleroderma) and systemic lupus erythematosus.
  • The trial will enroll approximately 200 patients

Phase III: Treatment for Autosomal Dominant Polycystic Kidney Disease

  • Pivotal Phase 3 trial in ADPKD initiated in May 2019
  • ADPKD is a genetic disorder characterized by the growth of numerous cysts in the kidneys.
  • Granted Orphan Drug Designation
  • Enrollment approximately 300 patients
  • Seeking accelerated approval from the FDA

 

DEVELOPMENT PROGRAMS:

Phase II: Treatment for IgA Nephropathy

  • IgAN, also known as Berger’s disease, is a kidney disease that occurs when IgA deposits build up in the kidneys, causing inflammation that damages kidney tissues.
  • Multicenter, phase 2 US in four separate patient cohorts.
  • The target enrollment is 25 to 30 patients per cohort.

Phase II: Treatment for Type 1 Diabetic Chronic Kidney Disease

  • Phase 3 trial fully enrolled, data available in 1H22. Sponsored by Japanese partner company.
  • Phase II US trial in four separate patient cohorts.
  • The target enrollment is 25 to 30 patients per cohort.

Phase II: Treatment for Focal Segmental Glomerulosclerosis

  • FSGS is a disease in which scar tissue develops on the parts of the kidneys that filter waste from the blood. FSGS is a serious condition that can lead to kidney failure, for which the only treatment options are dialysis or kidney transplant.

 

EARLY DEVELOPMENT PROGRAMS:

Phase I/II: Treatment for Neurodegeneration and Neuroprotection

  • Results from a phase 1 demonstrated an acceptable pharmacokinetic profile without apparent safety or tolerability issues.
  • C-Terminal Heat Shock Protein 90 Modulator with neuroprotective and neuroregeneration potential.
  • Favorable activity in neurodegeneration and neuroprotection, including diabetic neuropathy and neural inflammation

Phase I: Treatment for Autoimmune and Inflammatory Disorders

  • A phase 1 clinical trial is ongoing, initial results are expected in 2019
  • Demonstrated significant efficacy in rheumatoid arthritis and multiple sclerosis.

 

Clinical Development Leadership Objectives:

  • Provide leadership to clinical development activities and cross functional teams
  • Provide oversight to program(s) with early development through NDA filing and launch exposure.
  • Provide strategic Program Leadership
  • Key contributor to the continuous development of a corporate environment that is thoughtful about strategy and tactics, culturally intellectual and energetic.

 

Growth:

  • Ability to grow within an organization currently fairly small with numerous programs in development and will launch their own products. The organization will scale all aspects of the company including development activities.

     

    Company Overview:

    Clinical-stage biopharmaceutical company that develops novel therapeutics for patients with serious or life-threatening diseases by targeting molecular pathways involved in the regulation of cellular metabolism and inflammation. Multiple advanced clinical candidates target the important transcription factor Nrf2 that promotes restoration of mitochondrial function, reduction of oxidative stress, and inhibition of pro-inflammatory signaling.

    Selected Clinical Milestones in 2019

  • Pivotal program for Alport Syndrome - data in the second half of 2019
  • Pivotal program for Friedreich’s Ataxia - data in the second half of 2019

Competency Expectations:

  • Contribute medical and scientific clinical research experience to the development of overall strategy and objectives of the clinical development programs
  • Support program development, including working cross functionally with all of the disciplines necessary for successful drug development
  • Maintain complete and in-depth knowledge of the scientific and technical characteristics of assigned compounds in development or planning phase
  • Serve as a primary medical resource providing in-depth knowledge of products across therapeutic areas
  • Provide leadership to agency interactions
  • Demonstrate commitment and support for company goals, objectives and procedures
  • MD required
  • Past senior level clinical development experience ideally at a development stage biotech company
  • Knowledge of clinical development process and methods of scientific investigation, GCP, the FDA regulatory environment and guidelines, including study and protocol design. Must have safety familiarity for regulatory requirements.

 

Contact Information:

 

Michael Barros

Managing Partner, Prestige Scientific, Inc.

409 Fortune Blvd. Suite 202, Milford MA.

Direct Dial: 508-422-9342

Cell: 508-954-2516

mbarros@prestigescientific.com

Assistant: Alison Corshia

acorshia@prestigescientific.com



Posted On: Friday, July 24, 2020



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