Do you have expertise in Respiratory clinical development and passion for developing late phase clinical program strategies

Contribute to our growing pipeline. Join a place with the commitment knowledge and backing from the business to continue expanding our pipeline. With one of the broadest and deepest pipelines we are determined to keep contributing and pushing forward.

We have an exciting opportunity for a Global Clinical Program Lead to join our team within Late Respiratory and Immunology Clinical Late Development Respiratory you will work with a dedicated Respiratory team thats growing fast and building a consistent track record of success. We make bold moves at the groundbreaking. Redefining molecules to change the practice of medicine.

The role

As a Global Clinical Program Lead you are accountable to the Global Clinical Head for a significant proportion of the clinical program usually an indication-aligned cluster of clinical studies. This role is normally applied to portions of the program that have the highest degree of complexity based upon the known science or the size of the program and may also include a third-party collaboration.

In this capacity you will supervise a team of Global Development Medical Directors and/or Global Development Scientist Directors and also work cross functionally to support the design conduct monitoring and data interpretation of multiple studies. You will ensure that the clinical data collected within the studies will allow determination of the benefits and risks of the compound and meet the needs of the intended label indication and price in markets globally. As such you will get the chance to be strategic and patient focused generating opportunity and value for the asset or indication with an entrepreneurial approach to maintain a driven advantage.

You will set the vision and goals against therapeutic area leadership priorities and product strategy; ensure timely decision making; facilitate the balance of cost/time/quality against clinical development objectives; develop relevant risk mitigation strategies; enable quick and effective troubleshooting; represent the program at health authority interactions; review publications aligned to your program; and seek/share findings through your portfolio of studies.

The Global Clinical Program Lead will operate according to the highest ethical standards in compliance with internal SOPs local regulations laws and adhere to Good Clinical Practice and regulatory requirements.

What youll do:

• Clinical scientific and ethical components of studies including patient safety on a study and/or program level in compliance with Good Clinical Practice

• Scientific medical input to all relevant study documents (including and not limited to protocol statistical analysis plan amendments informed consent case report forms safety and risk-based monitoring plans) to ensure consistency within clinical program and alignment with scientific rationale.

• Scientific medical content at international investigator meetings and support to local Marketing Companies for country level activities

• Safety surveillance on a study level and/or program level including the process for Adverse Events (AE)/ Serious AE reporting.

• Reviews (with the GCH) the Clinical Study Report and plays key role in preparation and production of relevant sections (Introduction Results Discussion).

• Induction and education of new Global Study Team members.

• May also contribute to clinical trial improvement workstreams on behalf of the Clinical function.

• Accountable to GCH and TA leadership for identifying risks and proposing mitigation strategies to deliver successful phase IIb III IV or Life Cycle Management studies

• Delivery of clinical scientific and medical information/query responses to Regulatory Agencies Ethic Committees Marketing Companies and investigators/sites and provides clarifications as well as solves clinical scientific and medical issues in the Global Study Team

• Clinical representative on indication in Global and Clinical Product Teams and/or sub-teams

• Co-leads the study and program strategy for publication development and approval of publications with the GCH

• Line management of project study physicians and scientistswith up to 8 direct reports

Essential for the role:

• MD MBBS PhD or PharmD with specialist training or significant experience in either pulmonary medicine and extensive experience from clinical development in pharmaceutical industry or academia.

• Minimum of 5 years in pharma industry with experience in leading clinical trials to support approval (Phase 2-4)

• Knowledge of biostatistics global regulatory environment and pharmacovigilance relevant to the role

• Experience in leading a clinical program to support an indication: design clinical development plan and Target Product Profile.

• Experience in writing clinical aspects of briefing documents for regulatory interactions and played a critical role in writing sections of a submission dossier

• Good presentation skills and effective communication with internal and external collaborators

• Knowledge and experience to work across projects with a fast-learning curve when moving into new disease areas
  

Desirable for the role:

• PhD (or other complementary degree) in scientific field

• Education in Pharmaceutical Medicine

• Pharmaceutical industry R&D experience and in particular involvement in major clinical achievements and factors which influence drug development.

• Experience in matrix team environment with interplay between clinical commercial drug safety and regulatory

The annual base salary for this position ranges from $288059 - $ base pay offered may vary depending on multiple individualized factors including market location job-related knowledge skills and addition our positions offer a short-term incentive bonus opportunity; eligibility toparticipatein our equity-based long-term incentive program. Benefits offered included a qualified retirement program 401(k) plan; paid vacation and holidays; paid leaves; and health benefits including medical prescription drug dental and vision coveragein accordance withthe terms and conditions of the applicable of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and furtherance of that mission we welcome and consider applications from all qualified candidates regardless of their protected characteristics. If you have a disability or special need that requires accommodation please complete the corresponding section in the application form.