Jobs
>
Monmouth Junction

    Sr. Director, Clinical Operations - Monmouth Junction, United States - Tris Pharma

    Tris Pharma
    Tris Pharma Monmouth Junction, United States

    2 weeks ago

    Default job background
    Full time
    Description

    Tris Pharma, Inc. ) is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines addressing unmet patient needs. We have more than 150 US and International patents (including applications) and have marketed several branded and generic products in the U.S., have licensed our products in the US and international markets, and have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.

    Our science and technology make us unique, but our team members set us apart; they are the engine fueling Tris' passion and innovation. Tris colleagues understand the criticality of operating a successful business and take pride in the company's success. But of equal importance to each member of the team is how we interact with one another. We believe in each other and in respectful, open and honest communications to help support individual and team success.

    We have an immediate opening in our Monmouth Junction, NJ location for a Senior Director, Clinical Operations.

    The Senior Director, Clinical Operations provides expert strategic, scientific and operational leadership by leading strategic operational initiatives, building talent across the organization and by applying overall and specific project management and organizational leadership expertise to the clinical development portfolio. The incumbent is accountable for the Clinical Operations cross functional collaboration to develop program strategy and the implementation of clinical study processes and procedures ensuring timely execution of quality clinical trials complying with all regulations and/or guidance.


    • Collaborating closely with Vice President/Clinical Development, manages and supports the clinical operations function by outlining scope of clinical trial programs and aligning resource needs, timelines, cost of services, etc.; Provides operational and scientific strategy, design and execution for multiple programs across various therapeutic areas


    • Accountable for communication of key performance indicators (KPIs) including, but not limited to: progress, status updates, mitigation strategy/plans, escalation of issues for trial or program level deliverables to senior management, etc.); Develops, implements, and/or manages adequate systems and procedures to ensure efficient day-to-day operations meeting company and affiliates' clinical trial needs


    • Leads clinical trial vendor and vendor personnel selection including, but not limited to: Clinical Project Managers, Clinical Trial Managers, Clinical Data Managers, Regulatory Managers, Medical and Safety Managers, Biostatisticians, Medical Writers, etc. to meet clinical trial planning and execution obligations


    • Fosters a culture of quality-by-design in trial oversight and risk management across outsourced clinical trials, ensuring efficient issue resolution, risk mitigation and continuous improvement through strategic partnerships with Clinical Research Organizations (CROs) and vendors across all phases of drug development; Ensures compliance with established clinical and regulatory guidelines, operating systems and procedures in clinical trials and maintains Clinical Operations training including vendor personnel and external contractors


    • Provides oversight and support to CRO Clinical Operations and Project Management areas ensuring ability to meet clinical, regulatory and business objectives through efficient completion of delegated tasks; Participates in identification and evaluation of potential investigators and other service vendors performing clinical study work


    • May also function as a Clinical Trial Manager(CTM), as needed

    Requirements

    Special knowledge or skills needed and/or licenses or certificates required

    · Bachelors degree in (para)medical, pharmaceutical or science related field and minimum 10 years Clinical Operations and/or Clinical Trial Management experience in a pharmaceutical, biotechnology, clinical research or related industry in positions of increasing technical and operational responsibility


    • Thorough knowledge of Good Clinical Practices (GCPs), International Conference on Harmonistaion (ICH) guidelines and regulatory requirements for clinical trial management


    • Current working knowledge of Code of Federal Regulations (CFR) Title 21 and related Food and Drug Administration (FDA) guidance


    • Demonstrated ability to build strong relationships with external partners, CROs and vendors with proven experience managing contract and clinical finance activities to work effectively with representatives from a broad range of scientific disciplines


    • Demonstrated ability to effectively procure, manage, and control project resources


    • Solid understanding of clinical indications and the drug development process


    • People management experience


    • Ability to influence without direct authority

    Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. #LI-hybrid

  • Sun Pharmaceutical Industries

    Associate Director, Clinical Operations

    2 days ago

    Sun Pharmaceutical Industries Princeton, United States

    Associate Director, Clinical Operations · Sun Pharma Advanced Research Company Limited Princeton, New Jersey · Summary · The Associate Director, Clinical Operations is responsible for Oversight of the Project Management team, Clinical Research Associates, Clinical Trial Associate ...

  • Legend Biotech Corp

    director, clinical operations

    5 days ago

    Legend Biotech Corp Somerset, NJ, United States

    Company Information · Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including ...

  • Novo Nordisk

    Director - NACD (North America Clinical Dev) Operations

    3 weeks ago

    Novo Nordisk Plainsboro, United States Full time

    About the Department · The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to ...

  • Novo Nordisk

    Director - Nacd (North America Clinical Dev)

    1 day ago

    Novo Nordisk Plainsboro, United States

    **About the Department*** · The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA ...

  • Penn Medicine

    Cafeteria Cashier

    5 days ago

    Penn Medicine Plainsboro, United States

    **Description** · Penn Medicine is dedicated to our tripartite mission of providing the highest level of care to patients, conducting innovative research, and educating future leaders in the field of medicine. Working for this leading academic medical center means collaboration w ...

  • Penn Medicine

    Specialty Team Coordinator

    2 days ago

    Penn Medicine Plainsboro, United States

    **Description** · Penn Medicine is dedicated to our tripartite mission of providing the highest level of care to patients, conducting innovative research, and educating future leaders in the field of medicine. Working for this leading academic medical center means collaboration w ...

  • Novo Nordisk

    Manager - Contract Review and Compliance Reporting

    1 day ago

    Novo Nordisk Plainsboro, United States

    **About the Department*** · The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA ...

  • Penn Medicine

    Patient Access Associate Ed Ip Njs

    1 day ago

    Penn Medicine Plainsboro, United States

    **Description** · Penn Medicine is dedicated to our tripartite mission of providing the highest level of care to patients, conducting innovative research, and educating future leaders in the field of medicine. Working for this leading academic medical center means collaboration w ...

  • Novo Nordisk

    Associate Manager

    4 days ago

    Novo Nordisk Plainsboro, United States

    **About the Department*** · The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA ...

  • Bristol Myers Squibb Company

    Scientist, Clinical Supply Operations

    1 week ago

    Bristol Myers Squibb Company New Brunswick, United States Full time

    Working with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production lin ...

  • BioSpace

    Scientist, Clinical Supply Operations

    2 days ago

    BioSpace New Brunswick, United States

    Job Details · Working with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a ...

  • Aurora Solutions

    Team leadership for operations in nursing

    1 week ago

    Aurora Solutions Ten Mile Run, NJ, United States Freelance

    Are you looking for an employer who offers you diverse career opportunities and benefits? Then you've come to the right place at Knappschaft Kliniken. No matter which of our locations or professions you start in, you can expect a collaborative and respectful work atmosphere as we ...

  • BioSpace

    Director, Clinical Operations

    5 days ago

    BioSpace Basking Ridge, United States

    Job Details · Join a Legacy of Innovation 110 Years and Counting · Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our wo ...

  • Daiichi Sankyo Inc.

    Director, Clinical Operations

    18 hours ago

    Daiichi Sankyo Inc. Basking Ridge, United States

    **Join a Legacy of Innovation 110 Years and Counting** · Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class ...

  • Daiichi Sankyo

    Director, Clinical Operations

    2 days ago

    Daiichi Sankyo Basking Ridge, United States

    Job Description · Join a Legacy of Innovation 110 Years and Counting · Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging ou ...

  • Legend Biotech

    Director, Clinical Operations

    1 week ago

    Legend Biotech Trenton, United States

    Legend Biotech is seeking · Director, Clinical Operations · as part of the · Clinical Operations · team based in · Somerset, NJ. · Role Overview · The Director, Clinical Operations is responsible for leading the planning and management and oversight of the Legend Biotech p ...

  • Rocket Pharmaceuticals

    Corporate Paralegal

    4 days ago

    Rocket Pharmaceuticals Cranbury, United States

    Overview: · **Work at ROCKET PHARMA and help cure rare diseases** · Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member ...

  • Rocket Pharmaceuticals

    Manager, Information Technology

    4 days ago

    Rocket Pharmaceuticals Cranbury, United States

    Overview: · **Work at ROCKET PHARMA and help cure rare diseases** · Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member ...

  • EVOLUTION RESEARCH GROUP

    Director of Clinical Operations

    1 hour ago

    EVOLUTION RESEARCH GROUP Staten Island, United States

    Job Details · Job Location · LOC022 RBA Richmond Behavioral Associates - Staten Island, NY · Director of Clinical Operations · Title: Director Clinical Operations · Location: Staten Island, NY · About us: · ERG is a leading U.S. based, privately held, independent clinical resear ...

  • Evolution Research Group

    Clinical Operations Manager

    1 week ago

    Evolution Research Group Staten Island, United States

    Job Details · Job Location · LOC022 RBA Richmond Behavioral Associates - Staten Island, NY · Salary Range · $90, $110,000.00 · Clinical Operations Manager · Title: Clinical Operations Manager · Location: Staten Island · About us: · ERG is a leading U.S. based, privately held ...