Director, Clinical Research and Early Programmes Immunology - Durham, United States - GlaxoSmithKline

Description

Site Name:
UK - Hertfordshire - Stevenage, Belgium-Wavre, UK - London - Brentford, USA - Massachusetts - Waltham, USA - North Carolina - Durham, USA - Pennsylvania - Upper Providence

Posted Date:
May 3 2024
A

Director,

Clinical

Research and Early

Programmes

Immunology

is

sought

to provide clinical and scientific

insights

to the immunology franchise including emerging indications

and adjacencies

. You will work with

in

project teams to plan and

assure

delivery of clinical research and development activities. You will work with

early and

late

development teams to plan clinical development programs and

facilitate

close collaboration between

different groups

within the Respiratory

&

Inflammation Research Unit.
The responsibilities of the

Director

Clinical Research and Early

Programmes

Immunology

include (but are not limited to) several


key areas:
designing and

leading

, as

appropriate

,

clinical

development

protocols

/

studies/

programs

in Immunology

across all phases of development

, as required by business imperatives as part of clinical and medicine development matrix teams.

accountability for study Ph1-2/3 design

providing clinical expert input into regulatory documentation and

leading regu

latory interactions from clinical perspective for their studies/ indications, as appropriate

working

closely with

R

esearch

Unit

members to define

prioritised

clinical indication

s

for

early

target

s

and integrate inputs from across disciplines (scientific, clinical

,

commercial, regulatory

and stats

) to contribute to the

Medicine Profile, Target Validation

, Translational Plans

, Candidate Selection

.

, clinical development plan and integrated evidence pla

n

a

ccountab

ility

for

design and delivery of an earl

y

clinical development plan that effectively

demonstrates

proof of mechanism, potential efficacy, and a safety profile to support progression to full development

And/or accountability for

design and delivery of the full development clinical development plan that effectively

demonstrates

benefit-risk and leads to a successful submission

to regulators, payors

etc

accountability for leading the integrated evidence planning to address the needs of regulators,

payors

and patients

participating/

l

ead

ing

the

c

linical Team (CT) (or equivalent cross-functional clinical team)

and Integrated Evidence Team (IE

T)

a

ccounta

bility

for engaging external academic and clinical experts to enhance quality and delivery of

clinical

programmes

/

studies

a

ccountab

ility,

if medically qualified

,

for Medical Governance across the project to ensure scientific integrity and overall safety of the study subjects across all studies and other
GSKactivities/functions

impacting

safety and efficacy (

i.e.,

manufacturing, formulation, etc.)

a

ccountab

ility,

if medically qualified

,

for providing medical monitoring and oversight of the safety of study participants on behalf of the Sponsor during the study and, together with the Safety Pharmacovigilance Physician, providing input into aspects of study design that relate to subject safety

a

ccountability for providing clinical input into presentations, supporting documentation for and participation

in the

governance bodies presentations, as

requested

a

ccountab

ility

for escalation of clinical safety incidents to the

Immunology Clinical Research and Early Programs Head

and
GSKPharmacovigilance, as

appropriate

accountability

for clinical input to regulatory documentation to support the desired

indication

(e.g., IB, IMPD)

responsibility

for addressing clinical questions at meetings with regulatory authorities/ethics committees

a

ccountab

ility

for regulatory reporting requirements including Development Safety Update Reports (DSUR's) and IB updates

a

ccountab

ility

for incorporating patient perspective in the design and conduct of

clinical

studies

Leadership
You will be

experienced

in drug development

and/

or translational medicine

, preferably with industry experience

You will be expected to work across multiple projects

and

be independently accountable for your own projects

You will

be expected to input into disease area strategy

and be capable of executing this strategy based on your own

expertise

and that gained from your network

You will play a leadership role in – medical governance initiatives in R&D (

e.g.,

safety panel or governance board) – discovery/development policy,

processes

or guid

elines, as requested by the business

–

or in professional

networks in/outside of


GSK
You will be able to input into

relevant

business development activities

representing

, as

requested

You will be able to be

mentoring and coaching other members of

Clinical Research and Early

Programmes

Immunology

– applying extensive knowledge of clinical development to more than one research unit/disease area

You will be able to

build an external network with academia/pharma, bringing

expertise

back to
GSK
You will be able to

anticipat

e

,

communicat

e

,

and

suggest solutions

on trends/events outside
GSKthat affect our business direction –

utilizing

command of the drug discovery and development process to influence a culture of continuous

improvement

Candidate Profile

Basic Qualifications:
Doctor of Medicine


OR
'

MD,

PhD

'


OR
PhD with

industr

y

experience

S

ignificant

proven

clinical

or scientific

e

xpertise

in rheumatology/dermatology/immunology

Industry experience in translational medicine and early

/late

phase drug development

; e

xperience of setting and executing scientific strategy, whilst being mindful of overall company goals

Understanding and knowledge of early

/late

drug development

and

translational sciences

Qualifications & Preferable Expertise
In addition to the above, the following will be highly desirable:
Specialty training in rheumatology

/dermatology/ immunology

area, in particular lupus and

adjacencies

, would be

a

dvantageous

Experience in working with relevant regulatory bodies and professionals in early

/

late

stage

discovery and development

Project Management

Demonstrates the discipline of risk-based planning,

organizing,

and managing resources to bring about the successful completion of specific project goals and

objectives

in accordance with

defined quality and time-based metrics.

We're

excited to be moving to our vibrant new home on New Oxford Street in central London from the end of June 2024.

At
GSKHQ,

we're

building an

energising

space where we can connect,

collaborate

and get ahead of disease together. Designed especially for us,

it'll

be one of the healthiest workplaces in the world, with best-in-class tech and bright, light spaces to help us thrive.

Why GSK?
Uniting science, technology and talent to get ahead of disease together.

GSKis a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive.

We prevent and treat disease with vaccines, specialty and general medicines.

We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people.

While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making
GSKa place where people can thrive.

We want
GSKto be a place where people feel inspired, encouraged and challenged to be the best they can be.

A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles.

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