As the Clinical Development Director, daprodustat, you will be responsible for working with the Clinical Development Lead (CDL) for daprodustat, the Disease Area Lead (DAL) and other senior leaders in the Gastroenterology/Hepatology/Renal disease area to advance our clinical programs to treat the anemia of patients with chronic kidney disease (CKD). You may be provided the opportunity to support regulatory filings for daprodustat, support preparation of scientific presentations and publications and to work with our colleagues in global medical affairs to communicate the medical and scientific value that daprodustat provides to patients with CKD as well as design Phase 3b/ clinical trials.
This role will provide YOU with the opportunity to lead key activities to progress YOUR career; these responsibilities include some and/or all of the following:
- Act as Clinical Science Lead (CSL) for phase 3b/IV trials
- Physicians only: Act as medical monitor for phase 3b/IV trials
- Integrating scientific rationale, regulatory requirements, product development plan and commercial goals to optimize clinical study designs aligned with the Integrated evidence plan, and the clinical development plan
- Generating 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
- Communicating the benefits as well as the potential risks of daprodustat to patients with CKD through scientific publications and presentations at professional scientific meetings
- Leading and positively interfacing with a diverse range of scientific external experts (e.g. regulators, payors, clinical research organizations, consultants, investigators) in order to deliver the integrated clinical development strategy, aligned with the business strategy to achieve mutual goals related to patient needs
- Developing and maintaining relationships with program counterparts in Global Medical Affairs, Commercial, Research, Regulatory, Clinical Operations and Statistics
- Contributing to and partnering on the development of strategic initiatives, specific Business Development activities and various organizational initiatives in Clinical Sciences
- Delivering value and accessing insights to inform medical strategy, expand market access and to address unmet patient needs
- Leading and/or supporting clinical development discussions at regulatory interactions and clinical components of the submissions (i.e. IND, NDA, BLA, MAA) including briefing documents, presentations, addressing questions and responses
- Providing effective leadership support / oversight of evidence generation activities to assure patient safety and study delivery
- Anticipating problems and proactively seeking input from other team members/functional lines within R&D.
- Using scientific/operational expertise to solve study and/or project related problems
- Overcoming obstacles by experimenting with and adopting new ways of working including digital tools and technology
- Championing implementation of innovative methods and processes within clinical development and gains stakeholder support; encourages others to think differently and come up with business solutions
We are looking for professionals with these required skills to achieve our goals:
- Physician background (medical degree with significant clinical experience and ideally pharmaceutical industry experience, particularly in clinical development/trials OR Science PhD and/or PharmacyD degree, or considerablewith pharmaceutical development experience
- Extensive clinical training and/or applicable clinical research experience; understanding of clinical development planning and running clinical trial from concept study idea to publication
- Demonstrated experience managing complex projects and working collaboratively with multiple stakeholders regarding new strategies to ensure consistent communication
- Significant years of experience leading line and matrix teams with a strong reputation of inspiring and motivating high performance
- 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
If you have the following characteristics, it would be a plus:
- Extensive experience in clinical drug development for CKDfor renal or hematology products, with an understanding of the disease, the underlying biology and potential therapeutic targets as well as current and future potential treatment options
- Medical degree with clinical and/or clinical development experience in CKD
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