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ViiV Healthcare
Remote, United States (remote)
27 days ago

Description

ViiV Healthcare is a global specialty HIV company, the only one 100% focused on researching and delivering new medicines for people living with HIV and those wishing to prevent it. ViiV is highly mission-driven in our unrelenting commitment to be a trusted partner for all people impacted by HIV. We are fully committed to push through every challenge until HIV/AIDS is eradicated.

ViiV has played a significant part in delivering breakthrough medicines that have helped turn HIV into a chronic manageable condition. We offer the largest portfolio of HIV medicines available anywhere, and we continue our work to serve the widest possible range of needs across the global HIV epidemic.

We know what’s at stake for those affected by HIV and we show up every day with a 100% commitment. Our work culture is fast-paced, competitive, diverse, inclusive, caring, and supportive of the development needs of our staff. ViiV is not just a place to work – it’s a place to belong.  ViiV invites you to be your very best.  This is an especially exciting time to work in the Research and Development group at ViiV.  We are testing novel approaches to treatment, prevention that may further reduce the impact of HIV on our world. 

ViiV Healthcare was created as a joint venture by Pfizer and GlaxoSmithKline in November 2009 with both companies transferring their HIV assets to the new company. In 2012 Shionogi joined the company. 76.5% of the company is now owned by GlaxoSmithKline, 13.5% by Pfizer and 10% by Shionogi.

This open position is a Clinical Development Lead (Senior Director) role with responsibilities in either early or late-stage clinical development, or both.  Depending on background experience and your performance at ViiV, this role may also transition to a Medicines Development Lead (Senior Director) role.  In each role, you will contribute to our ViiV goal of leaving no patient with HIV behind. 

As the Clinical Development Lead (CDL) for an individual compound, you will provide clinical leadership for a cross-functional team of similarly committed people with expertise in other key areas of drug development and you will manage all clinical aspects of an R&D development program.  The CDL is also responsible for interacting with our internal medical governance structure to provide medical perspective on overall study conduct and procedures, and to ensure alignment with internal and external guidelines.  The CDL works closely with internal regulatory affairs colleagues to help develop regulatory strategy and to provide clinical support on global health authority interactions. The CDL also provides clinical oversight of study scientists and medical monitors to develop study schema, write and implement study protocols, to manage and make critical decisions for ongoing studies, to plan and execute efficient data collection procedures, and to assist with the interpretation and reporting of clinical study outcomes.

In addition, a key part of this role will be creating and maintaining effective working relationships both within cross-functional colleagues inside of ViiV and GSK, with external collaborators, with global regulatory authorities, with clinical investigators and with study support teams outside of the organization.

Qualified candidates with the appropriate background and experience level may have an opportunity to transition to the Medicines Development Lead (MDL).  In the MDL role, you will lead the development of innovative strategies and execute with agility, using evidence-based approaches to deliver on the promise of medicines.  MDLs are single point of accountability integrative leaders who head the Medicine Development Teams (MDTs) that deliver our medicines, provide cohesive and influential enterprise leadership of medicine development within the ViiV research and development organization, and ensure pipeline delivery and sustainability.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

  • Working closely alongside the MDT leader on an individual compound team in early or late development to determine the clinical strategy for the development of that compound
  • Designing, communicating, defending, executing on, and delivering the Clinical Development Plan for an individual compound
  • Providing clinical leadership at the project team level to ensure accuracy, quality, and timely delivery of the CDP and of all clinical components required for regulatory submissions throughout the life cycle of the compound 
  • Ensuring that all study protocols for the individual compound are developed and executed consistently within the Clinical Development Plan, that all study protocols are high-quality and conform with internal operating procedures and with external guidance requirements, that all study protocols reflect input from key internal and external stakeholders as appropriate, and that all protocol outcomes have the highest level of accuracy and scientific integrity
  • Leads and works with CSLs to build and manage External Expert and medical networks

Accountability

The CDL will report to the Vice President and Head, R&D Physician Center of Excellence.  The CDL serves on the Medicines Development Team under the matrix leadership of the MDT Lead and is accountable for clinical leadership for the compound under development.  The CDL is also accountable for interactions with medical governance activities, with regulatory interactions and with all clinical trial activities. 

Depending on background and experience, this CDL role may also have direct reports of other physicians within the Center of Excellence.  If this occurs, the CDL would also be responsible for managing those physicians, optimizing their professional development, and ensuring compliance with internal learning and external licensing requirements.   



Requirements

Basic Qualifications:

We are seeking professional clinical executives with these required skills:

  • Physician (MD or equivalent) with 10 plus years of Infectious Disease or HIV experience
  • Active medical license, or equivalent qualification to practice medicine
  • Drug development or clinical trials experience (5 years plus)

Preferred Qualifications:

The preferred candidate for this role will have the following:

  • Physician (MD or equivalent), with clinical fellowship in Infectious Diseases and/or HIV clinical treatment experience and/or experience in clinical development and/or clinical trials execution in Infectious Diseases
  • Significant drug development (5 or more years) and clinical trials experience (5 or more years), in HIV or Infectious Diseases, across all development phases
  • Excellent leadership experience with direct reports and leadership in a matrix environment
  • Effective communication skills, including the ability to build strong professional interpersonal relationships across multiple functional areas

Job Information

  • Job ID: 65374788
  • Workplace Type: Remote
  • Location:
    Remote, United States
  • Position Title: Clinical Development Lead, Senior Director, ViiV R&D Physician Center of Excellence
  • Company Name For Job: ViiV Healthcare
  • Area of Focus: Industry/Research
  • Job Function: MD
  • Job Type: Full-Time
  • Job Duration: Indefinite
  • Min Experience: Over 10 Years
  • Required Travel: 0-10%

ViiV Healthcare is a global specialty HIV company, the only one that is 100% focused on researching and delivering new medicines for people living with, and at risk of, HIV. ViiV is highly mission-driven in our unrelenting commitment to being a trusted partner for all people living with and affected by HIV. Our aim is to think, act, and connect differently through a focus on education on and treatment for HIV. We go to extraordinary lengths to deliver the sorts of breakthroughs, both in treatments, care solutions and commun...

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