GSK

Sr. Clinical Development Director - Rheumatoid Arthritis

Employer
GSK
Location
Collegeville, Pennsylvania; San Francisco, California; Waltham, Massachusetts
Salary
Competitive
Posted
October 26 2020
Ref
269121
Organization Type
Pharma
“ GSK is a company with a rich history of innovation, with many talented scientists who care deeply about translating great science into therapies that make a meaningful difference for patients” Hal Barron

Join us to today to make that meaningful difference as the Sr. Clinical Development Director for Otilimab, where you will be the Global Clinical Development Leader (CDL) for several clinical trials/registries to support clinical development for regulatory approvals of Otilimab. You will work closely with the Medicine Development Lead (MDL) for GSK's Otilimab programs. You will report into the Vice President, Disease area lead for Rheumatology, will be a member of the medicine development team, and will be responsible for direct reports.

This role will gives YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
  • Leading the strategic management of the Integrated Evidence Plan (IEP), including the Clinical Development Plan (CDP) for an asset in development
  • Ensuring alignment with and support of project strategic plans, regulatory requirements and commercial goals, optimizing clinical study design aligned with IEP and CDP
  • Generating the data and evidence required to determine a medicine's potential efficacy, safety profile, key areas of product differentiation and value to patients in the shortest possible timeframe
  • Delivering clinical development timelines, enabling key decision points and Go/No Go criteria for the CDP
  • Supervision of ongoing clinical studies of Otilimab in Rheumatoid arthritis and related immunological conditions including prospective phase 3 trials, as well as phase 2 trials in various indications to support regulatory approvals globally.
  • Developing and maintaining relationships with program counterparts in Commercial, Research, Regulatory, Clinical Operations and Statistics.
  • Contributing to the implementation and embedding of strategic initiatives and various organizational initiatives in Clinical Development
  • Supporting technical and leadership development of Clinical Sciences staff via mentoring and coaching for matrix team members
  • Actively contributing or leading the end-to-end clinical development strategy for a drug or program. Managing specific clinical development plans for product(s) and/or indication(s) in Rheumatology
  • Serving as a clinical point of contact for senior management and senior level matrix teams, both internally and externally for Otilimab in development
  • Interfacing and influencing a diverse range of scientific external experts (e.g. regulators, payors, Clinical Research Organizations, consultants, investigators) in order to deliver clinical programs and align to business strategy and address patient needs
  • Gathering and supporting the integration of inputs from across disciplines (scientific, clinical commercial, regulatory) to contribute to clinical components of the Medicine Profile.
  • Identifying and highlighting transformational opportunities where projects can offer highly significant benefit to patients in ways not possible with existing approaches
  • Contributing to regulatory interactions including briefing documents, presentations, addressing questions and responses
  • Providing effective support / oversight of evidence generation activities to assure patient safety and study delivery


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Bachelor's degree in a science related field
  • Experience in Rheumatology clinical drug development
  • Clinical training and/or applicable clinical research experience; experience with clinical development planning and running clinical trial from concept study idea to publication.
  • Experience managing complex projects and working with multiple stakeholders regarding new strategies to ensure consistent communication.
  • Experience integrating genetic data to advance disease understanding and and guide clinical development plans
  • Experience with clinical research methodology and biostatistics principles, to facilitate innovative and efficient clinical trial design, and clinical development plans with clear data-driven decision rules
  • Experience with digital tools intended to create innovation
  • Experience in inductive and deductive reasoning, statistics, and in providing mechanisms to interpret and analyze highly complex information including digital content


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • MD, PhD or PharmD degree valuable but not required
  • Thorough understanding of rheumatology and the rheumatoid arthritis autoimmune disease, the underlying biology and potential therapeutic targets as well as current and future potential treatment options
  • Robust knowledge of ICH guidelines, FDA requirements, regulatory and reimbursement data requirements in responsible area
  • Solid understanding of needs and priorities of regulators, payors and prescribers in relevant market(s)
  • Experience leading line or matrix teams with a strong reputation of inspiring and motivating high performance


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.

*LI-GSK

GSK_CDLeaders

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