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Clinical Program Director - Global Clinical Development

Company: Amazon Workforce Staffing
Location: Cambridge
Posted on: September 17, 2020

Job Description:

Clinical Program Director - Global Clinical Development Company: UCB S.A.

Location: Cambridge

Posted on: September 12, 2020

Job Description:

Let's push the boundaries together and make the most of yourtalents!

Clinical Program Director - Global Clinical DevelopmentLocation: Cambridge, Massachusetts, United States

Job Function: Clinical Development

Job ID: 68366

At UCB, we put our heart, soul and skills into making adifference for people living with significant unmet needs. Workingtogether, we blend the best of our talents to deliver thoughtfulsolutions that patients value. Will you join us in this pioneeringadventure?

To strengthen our Clinical Development Practice based in our RaPharmaceuticals – UCB site in North Cambridge, we are looking tofill the position of: Clinical Program Director .

As a Ra Pharmaceuticals - UCB Clinical Program Director you liketo work in an environment where you can:

Be responsible and accountable for all clinical aspects of theirassigned program(s)/missions

Provide leadership of the relevant clinical program(s) Phase 2 -4.

Lead and ensure adequate planning, design, defense, andimplementation of the clinical development strategy includinggeneration and appropriate revision of the Clinical DevelopmentPlan (CDP), clinical aspects of the Target Patient Value Profile(TPVP), and the Investigators Brochure (IB) to enable: Successfulregulatory filing, approval and launch of NCEs/NBEs, additionalregulatory approvals of new line extensions (indications orformulations) of registered compounds, prompt identification ofsafety or efficacy results that warrant re-evaluation of projectplan and/or potential termination prior to registration.

You will contribute by:

Leading or contributing to the development and subsequentrevisions of the CDP ensuring compatibility with the TPVP andrepresenting contemporary research approaches.

Ensuring that study concepts and final protocols related to therelevant clinical development plans are of high quality, representcontemporary research approaches, are aligned with related CDP(s)and TPVP(s), and are appropriately managed by the clinical studyteams.

Developing a strong knowledge base of the relevant disease areaand therapeutics and becoming the company expert for the respectivetreatment modality.

Developing and maintaining excellent working relationships andglobal cross functional collaboration together with all necessarystakeholders to ensure broad medical, scientific, regulatory,commercial and external input into the clinical programs.

In conjunction with the Program and Study Physicians, overseeingan ongoing evaluation of the benefit/risk ratio of thecompound.

Contributing to the ongoing safety evaluation of a product withreview of and/or contributions to aggregate reports and revisionsto Company Core Data Sheet and labels.

Leading or contributing to the planning and execution ofhigh-quality clinical components of regulatory submissions for theindication(s)/formulation(s). Responsible for on-time delivery ofclinical components of regulatory submissions.

Representing the company at meetings with RegulatoryAuthorities, partners, conferences, and advisory boards.

In conjunction with the Publications Team, serving as co-authorand/or reviewer of scientific publications of results of clinicalprograms.

Master’s Degree required with a PharmD, PhD or MD preferred

Depending on previous professional experience, a minimum of 3 to5 years of relevant experience in biopharmaceutical clinicaldevelopment is required, including the management of multipleclinical studies

Experience in development and execution of pediatric planspreferred

Knowledge of relevant therapeutic area (neurology,rheumatology/immunology or hematology) preferred

Knowledge of clinical study designs that apply real worldevidence (integrated patient databases such as claims and EMR) toclinical care is helpful

Demonstrated ability to think creatively and develop innovativesolutions; experience with real world evidence a plus

Experience supporting the development of Regulatory submissionsand presenting to regulatory authorities (e.g., FDA, EMA, PMDA)

Demonstrates clear and articulate verbal, written andpresentation skills with excellent command of the English languageand the appropriate comportment to represent UCB internationally atmeetings and congresses

Goal oriented, driven individual wo whishes to team up with agroup of enthusiastic, high performing indiviuals who canseamlessly transition between teamplayer and leading roles

Intellectual curiosity and mental flexibility is key

Listening, coaching, mentoring, facilitation, influencing andnegotiation skills

Ability to build effective team relationships with colleagues atall levels in the organization

Ability to work in a matrix type environment

About Us

At UCB, we come together every day to work, laser-focused, on asimple question: How will this create value for people living withsevere diseases? By putting patients at the heart of everything wedo, our approach – from discovery to development to delivery – iscontinuously transformed and designed around patient needs andtheir journey.

With a team of approximately 7,500 employees worldwideoperations in more than 40 countries, we are a globalbiopharmaceutical company investing more than a quarter of ourrevenue in cutting-edge scientific research. We are focused onaddressing chronic, neurological, immunological, and bone diseases.We are looking for people with passion and empathy who develop areal understanding of patient’s needs and can deliver thoughtfulsolutions to decisionmakers across the heath care ecosystem.

Curious to know more? Please visit our website www.ucb.com .

UCB and its subsidiaries encourage diversity and inclusion inthe workplace; we are an Equal Opportunity Employer. We do notdiscriminate on the basis of race/color/religion/sex/nationalorigin/veteran/disability/age/sexual orientation/genderidentity.

Keywords: UCB S.A., Cambridge , Clinical Program Director - Global Clinical Development, Other , Cambridge, Massachusetts

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Keywords: Amazon Workforce Staffing, Cambridge , Clinical Program Director - Global Clinical Development, Other , Cambridge, Massachusetts

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