Senior Clinical Development Leader

Research Triangle Park, NC
November 05 2020
Organization Type
Are you looking for an opportunity where you can lead the development of the medical governance framework in Research and Development? If so, this is the role for you.

As Physician Director you will lead the planning, development, implementation and continuous improvement of governance and compliance activities. In addition, you will raise awareness, support decision making, adherence and compliance of all policies and procedures involving external engagement of external regulations and impact to CIA obligations and requirements

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
  • Develop, design and embed a medical governance framework and standards within North American Medical Affairs guidelines.
  • Ensure robust quality controls are in place for external engagement activities.
  • Develop and embed a robust compliance training curriculum for all external engagement.
  • Prioritize and escalate external engagement-related risks.
  • Align with US Pharma Monitoring and Controls to ensure alignment of external engagement activities.
  • Monitor the quality and compliance performance of speaker programs and partners through assessment of compliance and quality trends.
  • Facilitate the implementation of quality improvements and ensure business critical quality improvements are adequately delivered.
  • Ensure governance and quality is fully integrated into strategic and operational planning and business processes involving external engagement activities.
  • Lead the external engagement governance team to ensure appropriate development and hiring of personnel in order.
  • Provide guidance to senior leadership to ensure that all external engagement activities comply with the implementation of the execution and risk mitigation Plan.
  • Responsible for leading and being accountable for the implementation of remediation and risk mitigation activities.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Medical degree
  • Background in the scientific/pharmaceutical industry in pharmaceutical research
  • 10+ years' experience in compliance, quality assurance and risk management areas, including root cause analysis
  • Experience with FDA regulatory guidelines
  • Experience with medical affairs activities including scientific engagement and promotional interactions

Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Master's in Quality Systems or equivalent (consult manager on equivalent)
  • Proven track record of dealing with complex problems with high integrity and confidentiality
  • Ability to deliver projects in the areas of Compliance, Quality and Risk Management
  • Ability to effectively communicate and have strong influencing skills
  • Proven record of delivery of process improvement
  • Awareness of Corporate Integrity Agreement and the Office of the Inspector General for safe harbor provisions
  • Knowledge with evolving regulatory expectations and global environment that impact external engagement risk areas
  • Ability to enable the organization to understand external requirements while achieving business objectives

Why GSK?

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 GSK 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.

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.

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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. ViiVshall 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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