GSK

Director, Early Clinical Development (Phase IIA & Later)

Employer
GSK
Location
Research Triangle Park, North Carolina
Salary
Competitive
Posted
January 12 2021
Ref
272968
Organization Type
Pharma
AS A VIIV HEALTHCARE EMPLOYEE, YOU ARE ALSO A GSK EMPLOYEE, RECEIVING 100% OF GSK'S TOTAL REWARDS & BENEFITS

ViiV Healthcare is an independent, global specialist HIV company combining the HIV expertise of GSK, Pfizer and Shionogi, with a broad portfolio of antiretroviral medicines, an industry-leading pipeline, and several first-of-their-kind programmes to improve access to medicines and support novel on-the-ground community initiatives. ViiV Healthcare has established presence in 16 countries and we are uniquely positioned to be at the forefront of advancing HIV treatment and care because we are the only pharmaceutical company 100% focused on HIV.

Through our focus on patient-centred innovation we have developed a strong portfolio of medicines that are advancing treatment and care for people living with HIV around the world. Our broad product portfolio includes a range of therapeutic options throughout the treatment spectrum. The primary focus is on the growth portfolio namely dolutegravir and cabotegravir based regimens as well as other assets and asset combinations from phase IIb through to in-market such as Tivicay, Triumeq as well as Juluca, Dovato, CAB/RPV, CAB prevention, fostemsavir, Maturation Inhibitors and other novel agents early in development pipeline.

The core purpose of the Director, Early Clinical Development (Phase IIA & Later) is to provide scientific leadership, direction, and contribution to the strategy employed in ViiV Healthcare clinical development programs. The Director, Early Clinical Development will lead a Team of Clinical Scientists supporting Early Development Programs. This role includes leadership of the study team in the design and development of high quality, timely studies (‘end to end' from Commit to Study to reporting and publication. Contributes to the medical governance and regulatory reporting at the study level by collaborating with operations colleagues to ensure accuracy, quality, and timeliness of study results.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
  • Leading a Team of Clinical Scientists supporting Early Development Programs

  • Helps drive ViiV Healthcare clinical development programs through support of matrix study team.

  • Accountable for the development, finalization, and amendments of study protocols with appropriate internal/external stakeholder input while ensuring protocol fulfills strategic objective of clinical development/ integrated evidence plan

  • Liaises with Medical, Commercial, and Asset Leads to ensure study evaluates key aspects of the Asset Product Profile critical to product differentiation/reimbursability where possible.

  • Provides scientific oversight of clinical studies, including assurance that data collection and study analysis plans are aligned with protocols, thereby allowing for intended scientific interpretation of study data and results.

  • Ensures by working with operations colleagues and matrix study team that all regulatory reporting requirements are met.

  • Co-ordinates with physicians and other study team members and stakeholders to enable appropriate review of safety data. May assist or take leading role in identification of safety review committee members and preparation of interim safety review charter document. Works closely with study physician(s) to help monitor safety and benefit/risk for studies.

  • Helps to create evidence generation and scientific outputs including content of investigator meeting, clinical study report, preparation of study results for scientific meetings, congresses, and external journal publications, preparation regulatory documents, and other relevant study documents.

  • Partners with operations colleagues to ensure optimal delivery of study while maintaining close collaborations with other functions supporting the study.

  • Contributes to quality assurance and inspection readiness activities



Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • B.S., Masters, Ph.D., Pharm.D., or MD with at least five years of recent clinical Early Drug Development Experience as the scientific lead of clinical program(s) and regulatory submission(s).
  • Three plus years leading a team (matrix or direct line management), 3rd parties, academic partners, and subcontracted organizations.
  • Experience with managing multiple programs concurrently


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Prior HIV drug development experience strongly preferred and antiviral, or infectious disease therapeutic area
  • Proven experience as line manager
  • Ability to respond with confidence to complex study questions using sound judgment and interpretation of applicable data
  • Ability to communicate complex scientific information concisely and clearly
  • Ability to influence (internally and externally) without formal authority


Why ViiV Healthcare?

Our values and expectations are 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.
  • Managing individual and team performance.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Implementing change initiatives and leading change.
  • Sustaining energy and well-being, building resilience in teams.
  • Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
  • Developing people and building a talent pipeline.
  • Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
  • Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
  • Budgeting and forecasting, commercial and financial acumen.


*This is a job description to aide in the job posting, but does not include all job evaluation details.

*LI-GSK

*LI-ViiV

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.

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. 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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