GSK

Clinical Development Leader (CDL), Prevention

Employer
GSK
Location
Research Triangle Park, North Carolina; Philadelphia, Pennsylvania; Collegeville, Pennsylvania
Salary
Competitive
Posted
October 29 2020
Ref
269013
Organization Type
Pharma
*ViiV Employees Receive 100% of GSK's Total Rewards and Benefits!

In this Clinical Development Lead (CDL), Prevention role, you will have an opportunity to contribute to the goal of leaving no patient behind and striving for new treatment options for people living with HIV. As the CDL on cabotegravir clinical studies for HIV prevention, 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 study scientists and medical monitors on 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 industry collaborators, global regulatory agencies and clinical investigators.

Job Purpose and Key Responsibilities:
  • Design and delivering the Clinical Development Plan (CDP), working with the Cabotegravir Medical Leader in the Medicine Development Team and Clinical Scientific Leaders (CSLs)/Study teams and confirmation of the data required to support development of the dolutegravir-containing products
  • Provide leadership at project level to ensure accuracy, quality and timeliness delivery of the CDP, and clinical components of required regulatory submissions throughout the life cycle (post-approval, post-promotion, and post-patent expiry as applicable)
  • Ensures high quality protocols are developed and executed with the Clinical Development Plan to effectively determine a medicine's potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe
  • Ensures study protocol, Clinical Study Report and other documents reflect input from internal and external experts/thought leaders
  • Ensures the accuracy and scientific integrity of Clinical input to Regulatory documents throughout the lifecycle (including development and post-approval periods)
  • Is recognised internally and externally as a leader in Drug Development and/or as an expert in HIV therapeutic area
  • Leads and works with CSLs to build and manage External Expert and medical networks


Accountability:
  • Accountable for medicine governance and regulatory reporting at the project level (and in support of the Clinical team) not only for clinical trial activities, but also including clinical interpretation of data from other functions that might impact safety and efficacy
  • Accountable for the Clinical activities within the Project in order to demonstrate a medicine's potential efficacy, safety profile, reimbursability, and value to patients/the company in a timely manner
  • Accountable for Medical Governance across the project to ensure scientific integrity and overall safety of the study subjects across all studies and other company activities/functions impacting safety and efficacy (e.g. Manufacturing, formulation etc)


Specialized Knowledge:

♦ breadth & depth across disciplines or functions; expertise in field required
  • 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 or clinical trials experience
  • Expertise in HIV drug development
  • Excellent leadership experience in a matrix environment
  • Understanding of running clinical trial from concept study idea to publication
  • Effective communication skills
  • Good interpersonal relationship building/maintenance


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Physician (MD or equivalent-Required) with 10 plus years of experience
  • Active medical license or equivalent qualification to practice medicine


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Clinical fellowship in Infectious Diseases
  • Significant drug development or clinical trials experience
  • Expertise in HIV drug development
  • Demonstrated leadership experience in a matrix environment
  • Understanding of running clinical trial from concept study idea to publication
  • Effective communication skills


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 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.


*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.

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