Director Clinical Operations

Prestige Scientific - Lexington, MA

Associate Director / Director Clinical Operations

(Retained Search – Level of hire scalable)

Summary:

This influential hire will have the opportunity to provide operational leadership to studies across the portfolio aimed at developing several highly novel peptide therapeutics. This intellectually curious hire will have the opportunity to drive operational strategies and decisions in support of executing successful clinical programs.

This hire will have the opportunity to work closely with clinical development, clinical sciences, translational sciences, and program management. This team is great at what they do but also great people as well.

The influence of this hire extends externally. This hire will have the opportunity to build relationships with study sites, investigators, and advisors. 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 scientific leadership to a growing and program teams
  • Drive early phase studies and development planning
  • 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:

• Responsible for overseeing the conduct of clinical studies in accordance with the timeline, cost and quality commitments
• Work closely with clinical team to oversee site selection and initiations and manage patient enrollment to timelines
• Lead study implementation and CRO oversight of clinical studies working closely with the clinical CRO and in-house study team
• Communicate regular study updates, maintain overview of study issues that potentially impact timeline, cost and/or quality commitments, while proactively communicating these to the matrixed program team and other stakeholders
• Ensure internal consistency across studies within a program and ensures alignment of operational program to the development team goals
• Serve as a liaison between clinical sites and study investigators
• Ensure quality of study management and inspection readiness
• Work across the portfolio to ensure harmony and efficiency of procedures for clinical trials management and vendor oversight
• Enable translational medicine by managing biomarker samples and vendors for timely tumor biomarker reporting for eligibility assessment
• Lead and support internal initiatives to develop best practices, lessons-learned, problem-solving and risk mitigation for clinical trial management
• Communicate clearly with teams and management
• Prepare and assist in safety reviews, dose escalation meetings, annual reports, SAE narratives and trend analyses
• Assist in clinical trial protocol drafts, study reports, amendments, informed consent forms, investigator brochures and other regulatory documents, taking an active part in discussions to ensure feasibility of study design and accuracy of data reported
• Work closely with team members to ensure efficiency, clarity and consistency in study documents and clinical development plans

 

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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