Executive Medical Director

Prestige Scientific - Lexington, MA

Executive Medical Director

(Retained Search – Level of hire moldable)

Summary:

This influential hire will have the opportunity to provide medical and scientific leadership to programs

across the portfolio aimed at developing several highly novel peptide therapeutics. This intellectually

curious Physician will have the opportunity to lead early development planning and study conduct while

thinking strategically during key interactions at the highest leadership levels.

This Physician will have the opportunity to help drive program activities and guide program teams. This

hire will also support strategic portfolio planning including toxin-conjugate and immune agonist

therapeutics. This role sits within a growing clinical department in the early oncology space involving

several highly novel bicyclic peptide therapeutics.

 

An entirely new class of therapies based on novel science

first conceived by the winner of the 2018 Nobel Prize in Chemistry.

A novel class of versatile, chemically synthesized medicines that are fully synthetic short peptides constrained to form two loops which stabilize their structural geometry. This constraint is designed to confer high affinity and selectivity, and the relatively large surface area presented by the molecule allows targets to be drugged that have historically been intractable to non-biological approaches.

Key properties:


§ Short peptides consisting of nine to 15 amino acids
  § Low molecular weight (1.5-2kDa), delivering attractive PK and rapid tissue penetration § No immunogenicity observed to date
  § Versatility for multimerization and conjugation
  § Large molecular footprint allowing protein-protein interactions to be targeted
  § Scalable and controllable manufacturing using established methodologies
  § Renal elimination, minimizing potentially deleterious bystander cell interactions in liver and gut
   

Immune Oncology Therapeutics:

Preclinical Program Target: Nectin-4 and agonizing CD137

ð Lead immuno-oncology candidate to advance into IND-enabling studies

ð A Novel, Fully Synthetic Tumor-targeted Immune Cell

ð Rapid tumor penetration and powerful anti-tumor activity

Preclinical Program Target: Anti-tumor

ð Studies suggest robust and durable anti-tumor effects, to include circumventing severe hepatotoxicity that prior programs using antibodies have shown in clinical trials.

ð A potential new treatment option for the large numbers of patients who stop responding to checkpoint inhibitors

ð In collaboration with the Cancer Research UK

 

Preclinical Program Target: Anti-tumor

ð EphA2/CD137 TICA

ð Show robust anti-tumor activity

 

Toxin-Conjugate Therapeutics:

Phase II Program Target: MT1-MMP

ð First-in-class cytotoxic drug conjugate with great potential for treatment of lung cancer and other solid tumors

ð In collaboration with the Cancer Research UK

 

Phase I/II Program Target: EphA2

ð First patient dosed, targeting advanced solid tumors

ð Phase I dose escalation has commenced in the U.S and will be conducted at sites in both the U.S. and UK

 

Preclinical Program Nectin-4

ð Displayed efficacy in preclinical tumor models

ð Multiple potential tumor types (e.g. bladder, breast, gastric, lung, esophageal & pancreatic)

 

Beyond Oncology:

Ophthalmology: Collaboration with Oxurion

ð Phase I trial developing a treatment for patients with visual impairment due to center-involved diabetic macular edema

Respiratory: Collaboration with AstraZeneca

ð Discovery/preclinical targets in respiratory and cardio-metabolic diseases

Anti-Infectives: Collaboration with Innovate UK

ð Discovery/preclinical studies to develop the next generation of novel antibiotics

CNS Diseases: Collaboration with Dementia Discovery Fund

ð Discovery/preclinical studies to develop new therapies for neurodegenerative diseases, including dementia

 

Clinical Development Leadership Objectives:

  • Provide medical and scientific leadership across the portfolio and program teams
  • Drive early development study conduct including study design, protocol development, regulatory documents, CRO interactions, IND preparations, etc.
  • Key contributor to the continuous development of a corporate environment that is thoughtful about strategy and tactics, culturally intellectual and energetic.

Company Overview:

Based on groundbreaking work this team is pioneering the development of bicyclic peptides – a novel class of versatile, chemically synthesized medicines. They are fully synthetic short peptides constrained to form two loops which stabilize their structural geometry. This constraint is designed to confer high affinity and selectivity, and the relatively large surface area presented by the molecule allows targets to be drugged that have historically been intractable to non-biological approaches. They represent a unique therapeutic class, combining the pharmacological properties normally associated with a biologic with the manufacturing and pharmacokinetic advantages of a small molecule, yet with no signs of immunogenicity observed to date.

Latest news: $1.7 billion in total milestone payments

This month we entered into a drug discovery partnership with and industry big-pharma.

$30 million up front. As programs progress, could earn up to $1.7 billion in total milestone payments, plus royalties. None of the cancer drugs currently in the pipeline are included in the partnership.

The partnership covers up to four drug candidates addressing multiple immuno-oncology targets. Milestone payments tied to development, regulatory, and initial commercialization could total up to $200 million per program. Additional payments when commercialized products achieve sales milestones.

Competency Expectations:

• Coordinate early development study conduct including study design, protocol writing, regulatory documents, CRO interactions, study start up, investigator interactions, data monitoring, health authority interactions, analyses and study reports.
• Oversee IND preparations
• Provide guidance to clinical scientists and study team members in particular with regard to medical and safety issues, data cleaning, data summaries and study progress
• Ensure clear presentations at site initiations, investigator meetings, safety meetings and advisory sessions
• Act as clinical lead to ensure efficiency, safety and innovation for clinical programs
• Work across the portfolio to ensure harmony and efficiency in the early clinical space
• Enable translational medicine by working closely with biomarker scientists
• Assist in organizing pre-clinical, clinical, literature, conferences and competitive data to generate development plans
• Bring strategic concepts into development by co-organizing advisory boards and expert consultations
• Lead and support internal initiatives to develop best practices, lessons-learned, problem-solving and risk mitigation
• Assist in scientific advisory boards, conference activities, external collaborations and partnerships
• Lead in safety reviews, dose escalation meetings, annual reports, SAE narratives and trend analyses
• Lead efforts in clinical trial protocol drafts, study reports, amendments, informed consent forms, investigator brochures, INDs, briefing books and other regulatory documents
• Contribute to publication strategy and preparation of abstracts, posters and manuscripts

 

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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