Centessa Pharma- Clinical Development Lead

2 weeks ago

Cambridge, United States The Higgins Group Corp Full time

COMPANY OVERVIEW

Centessa discovers and develops medicines that are transformational for patients. The company operates its clinical research with the conviction that each one of the programs has the potential to change the current treatment paradigm and establish a new standard of care. Centessa aims to achieve this patient-centric mission with a focus on developing a portfolio of highly innovative assets, unconstrained by therapeutic area or technology.

Centessas core medical research operating principle is to make timely, unbiased decisions driven by data and biology. The company focuses on making the best decisions for each asset without constraints or bias stemming from the needs of other programs in the portfolio. Contessa is confident this unencumbered, asset-centric philosophy has the potential to deliver significant value for all stakeholders. For more information, visit www.centessa.com.

THE POSITION

The Clinical Development Lead will lead the design and execution of global clinical studies involving Centessas Orexin agonist(s) in support of one or more development programs in various sleep and CNS disorders. This role will work closely with cross functional team members to execute all activities associated with study conduct and interpretation of data from clinical trials. This individual will engage key external partners in the medical and scientific community and will provide medical expertise to support regulatory submissions and interactions with global regulatory authorities. They will need to demonstrate strong hands-on leadership, communication, and relationship building skills to drive results in a matrixed environment.

This position is ideal for those seeking:

  • A high-impact role on Centessa's flagship program that will shape and lead the strategy of Orexin with expansion into additional neurological disorders
  • The opportunity to lead a potential best in class asset with potential to transform standard of care for individuals with sleep-wake disorders
  • A lean, fast-paced organization in growth mode with the need for sleep medicine expertise and leadership both internally and externally
  • A collaborative, agile, and data & patient-driven culture

Key responsibilities include:

  • Author clinical study protocols for orexin agonists in various sleep disorders
  • Provide scientific and medical expertise to effectively execute clinical studies and advance accelerated development programs
  • Lead the design of a cross-functionally aligned clinical development plan to advance multiple orexin agonist candidate molecules
  • Collaborate with clinical operations to meet timeline, cost and quality performance expectations and achieve program milestones
  • Provide medical insight and leadership in the design of translational medicine approaches exploring indication expansion opportunities
  • Effectively communicate and collaborate across internal disciplines and with key external partners, experts, and investigators to position orexin agonist programs at the forefront of research and development for new medicines in sleep disorders
  • Provide oversight of study integrity and timelines, and communication of information pertaining to safety and efficacy of clinical candidate molecules
  • Author/ review clinical sections of regulatory documents, clinical study reports, scientific publications and presentations, and other program documents
  • Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and quality standards in conducting clinical research

The ideal candidate will have the following mix of personal and professional characteristics:

  • MD degree in Neurology, Sleep Medicine, or related area; Board Certification preferred
  • Clinical and/or academic experience in sleep medicine; pharmaceutical industry experience is highly preferred
  • Experience in early clinical development with successful design and implementation of proof-of-concept studies in the neuroscience area is highly desired
  • Knowledge of US and EU regulatory guidelines and experience in interactions with regulatory agencies
  • Outstanding written and verbal communication, with a passion for problem solving and effective cross-functional stakeholder engagement
  • Ability to work independently and thrive in a fast-paced, dynamic matrix environment
  • An entrepreneurial spirit with high degree of energy and personal accountability

SCIENCE AND PIPELINE

Centessas programs span discovery-stage to late-stage development and cover a range of high-value indications. The company aims to pursue programs it believes could be first-in-class / best-in-class and where there is prior learning in human genetics or precedented human activity for a pathway of interest. Centessa places a premium on learnings from its clinical trials, whereby a drug has established the relevance of a biological pathway contributing to disease outcome. The approach is to pursue the best assets in a capital efficient manner and rapidly progress programs through development, evaluating the unique biological advantage of product candidates.ORX750 OVERVIEW

Centessa is developing ORX750, an oral selective orexin receptor 2 (OX2R) agonist designed to leverage unique structural insights and to directly target the underlying pathophysiology of orexin neuron loss in NT1 with potential expansion into other sleep disorders.

CULTURE AND CORE VALUES

  • AssetCentric We seek to pursue the best assets in a capital efficient manner with focused development teams and data-driven decision making to rapidly progress our programs through development.
  • PatientCentric Through our approach, we strive to deliver medicines that can lead to significant impact for patients who are desperately in need of new treatments.
  • Transformational Medicines Our programs span discovery-stage to late-stage development and cover a range of high-value indications in rare diseases and immuno-oncology.

Centessas unique culture reflects its commitment to these principles. Employees embrace simplicity, pragmatism, make hard decisions, work with a sense of urgency and expect extraordinary results.

by Jobble

  • Associate Director, Clinical Operations

    2 weeks ago

    Cambridge, United States Clinical Dynamix, Inc. Full time

    Role: Associate Director, Clinical Operations We are looking for a energetic and passionate Associate Director, Clinical Operations who is excited to plan and lead timely and high quality oncology clinical trial execution. The ideal candidate has a track record of executing complex, on-time clinical trials at a biotech/pharma company and has begun working...

  • Sr Clinical Research Scientist

    1 week ago

    Cambridge, United States Aequor Full time

    Job DescriptionJob DescriptionWe're looking only for a Senior level Clinical Research Scientist. Location is Hybrid, a minimum of 2 days onsite in Cambridge MA.This role is key to help the medical supervision of clinical studies by Clinical Research Directors (CRD) and to ensure scientific management of clinical studies to be performed by the Clinical &...

  • IT Program Coordinator

    6 days ago

    Cambridge, United States Infotree Global Solutions Full time

    No C2C and/or H1B Please!!Job Title: IT Program Coordinator/IT Operations Coordinator- (PHARMA/BIOTECH) W2 Contract Onsite roleWork Location: Cambridge, MAOne of our leading Pharmaceutical client is looking for a IT Program Coordinator/IT Operations Coordinator- (PHARMA/BIOTECH), who will Serve as the liaison between IT teams and multiple vendors in a global...

  • IT Program Coordinator

    2 days ago

    Cambridge, United States Infotree Global Solutions Full time

    No C2C and/or H1B Please!! Job Title: IT Program Coordinator/IT Operations Coordinator (PHARMA/BIOTECH) W2 Contract Onsite role Work Location: Cambridge, MA One of our leading Pharmaceutical client is looking for a IT Program Coordinator/IT Operations Coordinator (PHARMA/BIOTECH), who will Serve as the liaison between IT teams and multiple vendors in a...

  • IT Program Coordinator

    7 days ago

    Cambridge, United States Infotree Global Solutions Full time

    No C2C and/or H1B Please!!Job Title: IT Program Coordinator/IT Operations Coordinator– (PHARMA/BIOTECH) W2 Contract Onsite roleWork Location: Cambridge, MAOne of our leading Pharmaceutical client is looking for a IT Program Coordinator/IT Operations Coordinator– (PHARMA/BIOTECH), who will Serve as the liaison between IT teams and multiple vendors in a...

  • IT Program Coordinator

    1 week ago

    Cambridge, United States Infotree Global Solutions Full time

    No C2C and/or H1B Please!!Job Title: IT Program Coordinator/IT Operations Coordinator– (PHARMA/BIOTECH) W2 Contract Onsite roleWork Location: Cambridge, MAOne of our leading Pharmaceutical client is looking for a IT Program Coordinator/IT Operations Coordinator– (PHARMA/BIOTECH), who will Serve as the liaison between IT teams and multiple vendors in a...

  • IT Program Coordinator

    19 hours ago

    Cambridge, United States Infotree Global Solutions Full time

    No C2C and/or H1B Please!!Job Title: IT Program Coordinator/IT Operations Coordinator– (PHARMA/BIOTECH) W2 Contract Onsite roleWork Location: Cambridge, MAOne of our leading Pharmaceutical client is looking for a IT Program Coordinator/IT Operations Coordinator– (PHARMA/BIOTECH), who will Serve as the liaison between IT teams and multiple vendors in a...

  • Pharma Lab IT Support Engineer

    2 weeks ago

    Cambridge, United States Sailotech Full time

    Position: Pharma Lab IT Support Engineer Location: Cambridge MA (Onsite) Duration:12 months Required Skills: BS in Science, Computer/Information Technology, Bioinformatics or Engineering. Six plus years of progressively advancing experience in: Pharmaceutical operations or software development in pharmaceutical environment. Process automation...

  • Security Officer Corporate Pharma

    2 days ago

    Cambridge, United States Allied Universal® Full time

    Security Officer Corporate Pharma **Overview**: Allied Universal®, North America's leading security and facility services company, provides rewarding careers that give you a sense of purpose. While working in a dynamic, diverse and inclusive workplace, you will be part of a team that fuels a culture that will reflect in our communities and customers we...

  • Director, Clinical Operations

    2 weeks ago

    Cambridge, United States Boston Pharmaceuticals Full time

    Company Overview Boston Pharmaceuticals is a clinical-stage biopharmaceutical company. We are developing highly engineered targeted therapies for patients with serious liver diseases. Our lead investigational program, BOS-580, is a long-acting once-monthly FGF21 analogue being studied in a Phase 2 clinical trial for metabolic dysfunction-associated...

  • Clinical Monitoring Lead

    2 weeks ago

    Cambridge, United States TalentBurst, Inc. Full time

    Experienced clinical scientist (PharmD, PhD, Nurse, etc..) in clinical development needed to support rare disease clinical trials from protocol development, study start up activities including investigator meetings, working closely with CRO and internal study team to meet study milestones, regulatory form creation and submission, ongoing data review,...

  • Medical Development Director

    1 week ago

    Cambridge, United States Ipsen Biopharmaceuticals, Inc. Full time

    Title: Medical Development Director   Company: Ipsen Bioscience, Inc.   Job Description: Ipsen is seeking an experienced Medical Director, Clinical Development to join our team and embark on a unique journey of advancing our clinical development programs in rare cholestatic liver disease. In this position, you will be an integral part...

  • Medical Development Director

    1 week ago

    Cambridge, United States Ipsen Biopharmaceuticals, Inc. Full time

    Title:Medical Development DirectorCompany:Ipsen Bioscience, Inc.Job Description:Ipsen is seeking an experienced Medical Director, Clinical Development to join our team and embark on a unique journey of advancing our clinical development programs in rare cholestatic liver disease. In this position, you will be an integral part of the clinical development...

  • Director, Clinical Operations

    2 weeks ago

    Cambridge, United States Boston Pharmaceuticals Full time

    Company OverviewBoston Pharmaceuticals is a clinical-stage biopharmaceutical company. We are developing highly engineered targeted therapies for patients with serious liver diseases. Our lead investigational program, BOS-580, is a long-acting once-monthly FGF21 analogue being studied in a Phase 2 clinical trial for metabolic dysfunction-associated...

  • Medical Development Director

    2 weeks ago

    Cambridge, Massachusetts, United States Ipsen Biopharmaceuticals, Inc. Full time

    Title:Medical Development DirectorCompany:Ipsen Bioscience, Inc.Job Description:Ipsen is seeking an experienced Medical Director, Clinical Development to join our team and embark on a unique journey of advancing our clinical development programs in rare cholestatic liver disease. In this position, you will be an integral part of the clinical development...

  • Senior Clinical Trial Manager

    2 weeks ago

    Cambridge, United States Boston Pharmaceuticals Full time

    Company Overview Boston Pharmaceuticals is a clinical-stage biopharmaceutical company. We are developing highly engineered targeted therapies for patients with serious liver diseases. Our lead investigational program, BOS-580, is a long-acting once-monthly FGF21 analogue being studied in a Phase 2 clinical trial for metabolic dysfunction-associated...

  • Medical Development Director

    2 weeks ago

    Cambridge, United States BioSpace Full time

    Job DetailsTitle:Medical Development DirectorCompany:Ipsen Bioscience, Inc.Job Description:Ipsen is seeking an experienced Medical Director, Clinical Development to join our team and embark on a unique journey of advancing our clinical development programs in rare cholestatic liver disease. In this position, you will be an integral part of the clinical...

  • Senior Clinical Trial Manager

    2 weeks ago

    Cambridge, United States Boston Pharmaceuticals Full time

    Company OverviewBoston Pharmaceuticals is a clinical-stage biopharmaceutical company. We are developing highly engineered targeted therapies for patients with serious liver diseases. Our lead investigational program, BOS-580, is a long-acting once-monthly FGF21 analogue being studied in a Phase 2 clinical trial for metabolic dysfunction-associated...

  • Vice President, Clinical Development

    2 weeks ago

    Cambridge, United States Editas Medicine, Inc. Full time

    At Editas, we're driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing. We believe our people are at...

  • Vice President, Clinical Development

    2 weeks ago

    Cambridge, United States LifeMine Therapeutics Full time

    LifeMine is seeking a physician to work in partnership with CMO and co-lead the development of LifeMine's clinical strategy. The successful candidate will have experience in the design and authorship of clinical trial protocols including first-in-human clinical trials, selection, and implementation of biomarkers. The VP will also provide medical oversight of...