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Medical Monitor, Director, ViiV R&D Physician Center of Excellence

Employer
GSK
Location
Philadelphia, Pennsylvania
Salary
Competitive
Closing date
Sep 26, 2022

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*VIIV EMPLOYEES RECEIVE 100% OF GSK'S ROBUST BENEFITS AND TOTAL REWARDS!

*POTENTIAL REMOTE OPPORTUNITY FOR THE RIGHT CANDIDATE

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 Shionogijoined 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 Medical Monitor (MM) Medical Director role with the primary responsibility of developing, setting up, managing, and reporting out data from Phase 1-4 clinical trial protocols. In this role, you will contribute to our ViiV goal of leaving no patient with HIV behind.

As the Clinical Trial Director working on clinical trials, you will be responsible for medical governance for Phase 1-4 studies, providing your medical perspective on overall study conduct and procedures, and working closely with the other project physicians and key leaders in virology, pharmacology, biostatistics, and discovery science on the interpretation and reporting of clinical study data & results. In addition, a key part of this role will be creating and maintaining effective working relationships both within ViiV & GSK, as well as with external project collaborators such as academic universities, and other research collaboratives to ensure ethical and effective delivery of clinical studies.

This MM role provides the opportunity to manage key activities and to progress your career. The key responsibilities may include:
  • Contribute to study protocol development concepts and protocol writing
  • Contribute to the development of the supplementary study documents, including but not limited to study procedures manual, reporting and analysis plan, protocol deviation management plan, etc.
  • Contribute to the development of responses to regulatory authority's queries regarding clinical studies
  • Support the clinical scientists in the preparation of answers to local Institute Review Board and Ethical Review Committee questions
  • Address medical issues and concerns that arise during the study feasibility assessment, interacting directly with leading investigators and their study teams
  • Provide medical perspective on overall study conduct, procedures, and management of safety events to clinical study team
  • Liaise, with the study team operational collaborators and with sites and investigators to obtain all necessary documentation to assist with safety reviews
  • Liaise with other external collaborators and scientific consultants


Accountability

The MM will report to either the Vice President and Head, R&D Physician Center of Excellence, or a Clinical Development Leader (Senior Director) within the physician's group, depending on background and experience level. The MM serves on the Medicines Development Team and the Clinical Team under the matrix leadership of the Medicines Team Leader and the Clinical Development Team Leader, and the MM is accountable for clinical leadership of Phase 1-4 protocols assigned within the development program. The MM provides review and approval of study protocols and coordinates the writing and completion of the risk section of ICF with functional colleagues. The MM provides training in subject protocol-defined safety parameters and toxicity management to internal and external study team members during protocol development and study start-up. The MM synthesizes and present clinical information from the trial, coordinates closely with safety and pharmacokinetic representatives on the team, and provides evaluations to internal governance groups as appropriate (including Safety Review Team, ViiV Safety and Labelling Committee, etc.). The MM provides guidance regarding protocol-related medical issues to collaborators, site investigators and other study support staff as needed and in a timely manner. The MM ensures electronic protocol inquiries and site interactions, inclusive of safety events and other study-related matters are filed in the study electronic Trial Master File as required.

Why you?

Basic Qualifications:

We are seeking professional clinical executives with these required skills:
  • Physician (MD or equivalent) with 3 plus years of Infectious Diseases or HIV experience
  • Active medical license, or equivalent qualification to practice medicine
  • Drug development OR clinical trials experience


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
  • Drug development (2 or more years) and clinical trials experience (2 or more years), in HIV or Infectious Diseases
  • Leadership experience, including working within a matrix environment
  • Effective communication skills, including the ability to build strong professional interpersonal relationships across multiple functional areas


Why ViiV Healthcare?

Our values and expectationsare at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As ViiV focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
  • Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk, governance and control, managing ambiguity and paradox.
  • Managing individual performance.
  • Creating a performance culture and driving results, prioritisation, execution, delivering performance.
  • Setting strategic direction and leading on-going organisational transformation.
  • Building a resilient organisation.
  • Building strong relationships and collaboration in service of common goals, engaging the organisation and building trusted external networks for mutual benefit.
  • Managing P&L and capital allocation.


*LI-GSK

If you require an accommodation or other assistance to apply for a job at ViiV, please contact the ViiV Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

ViiV is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

At ViiV, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.

ViiV has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.

Important notice to Employment businesses/ Agencies

ViiV does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact ViiV's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to ViiV. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and ViiV. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of ViiV. ViiV shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, ViiV may be required to capture and report expenses ViiV incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure ViiV's compliance to all federal and state US Transparency requirements. For more information, please visit ViiV's Transparency Reporting For the Record site.
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