Clinical Development Director, Respiratory
- Weston, MA
Site Name: UK - London - Brentford, USA - California - San Francisco, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Stevenage
Posted Date: Nov 4 2020
Clinical Development Director, Respiratory
Here at GSK, we place the patient at the heart of everything we do and as leaders in respiratory disease, we are committed to improving the lives of those living with asthma, COPD and other respiratory-related illnesses. We are constantly striving to expand knowledge and the understanding of respiratory disease to help revolutionise the way that medicines are developed. We are focused on identifying new scientific insights, applying our expertise
and developing innovative new medicines that enable clinicians to tailor treatment to patients' individual needs. Join our dynamic & collaborative community of clinical development physicians and scientists, as we drive scientific innovation to deliver the next generation of transformational medicine for patients.
We're seeking a Clinical Development Lead for emerging indications and assets within the Respiratory Clinical Sciences group. As Clinical Development Director - Respiratory Disease, you will lead phase 2A studies through to registrational programs.
Job purpose and key responsibilities:
- Supporting 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 to 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 patient in the shortest possible timeframe.
- Delivering clinical development timelines, enabling key decision points and Go/No Go criteria for the CDP.
- 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 managing and contributing to the end-to-end clinical development strategy for a drug or program. Manages specific clinical development plans for product(s) and/or indication(s) in assigned therapy disease area.
- Serving as a clinical point of contact for senior management and senior level matrix teams, both internally and externally for an asset in development.
- Interfacing and influencing a diverse range of scientific external experts (e.g. regulators, payors, CROs, 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.
Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:
- MD, PhD or PharmD degree.
- Significant experience in clinical drug development with an understanding of respiratory disease, the underlying biology and potential therapeutic targets as well as current and future potential treatment options preferred, but not mandatory.
- Significant clinical training and/or applicable clinical research experience; understanding of clinical development planning and running clinical trial from concept study idea to publication.
- Robust knowledge of ICH guidelines, FDA requirements, regulatory and reimbursement data requirements in responsible area.
- Solid understanding of needs and priorities of regulators, payers and prescribers in relevant market(s).
- Demonstrated experience using new learning and digital tools to create innovation in other areas.
- Thorough understanding of clinical research methodology and biostatistics principles, to facilitate innovative and efficient clinical trial design, and clinical development plans with clear data-driven decision rules.
- Demonstrated experience integrating genetic data to inform and guide clinical protocols.
- Proven ability to utilize statistics, and visualisation techniques to interpret or analyse complex information and make correct inferences and conclusions.
Preferred Qualifications: If you have the following characteristics, it would be a plus:
- Experience leading line or matrix teams with a strong reputation of inspiring and motivating high performance.
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:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being.
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness.
When you set out on your adventure at GSK, we make a deal. You commit to living GSK's values and expectations and performing against our Innovation, Performance and Trust priorities. And in return, GSK commits to providing the right environment for you to thrive. Put simply, it's about you being motivated to do your best work, in a place where you can be you, feel good and keep growing.
Together we build an environment where we can all thrive and focus on what matters most to each of us. It is only through the energy, dedication, drive and passion of all of us that we can be the very best for GSK, and importantly, for our patients and consumers.
As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, 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(US only).
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