Senior Director Of Clinical And Non-Clinical Pharmacology

This is what you will do:
The Senior Director of Clinical and Non-Clinical Pharmacology leads a team of clinical pharmacologists and provides technical and strategic leadership on issues related to clinical pharmacology and pharmacokinetics and pharmacodynamics (PK/PD) from the discovery stage up to the post-marketing support (PMS) stage.
The overall responsibilities include providing clinical pharmacology functional line leadership and oversight in designing and executing, within the regulatory framework, non-clinical DMPK and toxicokinetic (TK) studies during the discovery phase, and FIH, POC, Phase 1 to 4 studies during the clinical development phase for R&D projects.
You will be responsible for:

• Leading development of non-clinical and clinical PK/PD/Immunogenicity strategy spanning animal POC, TK, IND enabling ADME package, FIH, Phase 1 and 2, POC, and late phase (Phase 2-3) trials, and regulatory interactions and documentations. Get consensus from project teams and participate in discussions and presentations to senior management
• Direct/implement non-clinical activities up to IND and support internal go-no-go decisions at Alexion: In vitro metabolism, non-clinical ADME, PK-PD data analysis and interpretation from animal models, TK and evaluation of potential of drug-drug interactions of new biological/small molecule entities; recommend the starting dose in FIH trials based on allometric scaling or physiologically based PK modeling
• Run clinical activities post IND up to registration; and support internal go-no-go decisions at Alexion: FIH to Phase 2 data analysis to recommend Phase 3 dose regimen; Phase 3 data analysis and authoring registration documents; Authoring clinical pharmacology development plans and supporting generation of integrated clinical development plan (ICDP); Contribute to the preparation of the pre-IND, IND, IB, IMPD, and regulatory briefing documents
• Lead and ensure selection of dosing regimen for nonclinical studies and FIH studies during the pre-IND stage and to lead the selection of dose for Phase 2/3 studies by ensuring integrated data analysis support.
  

You will need to have:

• PhD or Equivalent) in pharmaceutical sciences or similar specialty
• 15+ yrs of industry and research experience in Drug Development.
• Hands-on experience in the area of PK/PD/Immunogenicity, modeling and simulation and drug development in multiple therapeutic areas. Experience across range of development phases is must. Extensive experience in developing the strategy & designing, directing & implementing clinical pharmacology plans for multiple compounds, both biologics and small molecules.
• Knowledge of the current practices and issues in the bioanalytical, biopharmaceutics, nonclinical metabolism and pharmacokinetics, safety pharmacology and toxicology areas
• Technical and practical knowledge of global regulations, regulatory guidances, ethical issues associated with clinical studies and drug development SOPs. History of leading oral presentations to the global regulatory agencies
• Experience successfully delivering regulatory documents (reports, INDs, briefing documents, CTD/MAAs etc.) and representing company at the regulatory agencies, e.g. pre-IND, EOP2, pre-NDA, labeling and advisory committee and/or oral hearing meetings.
  

We would prefer for you to have!

• Knowledge of managing departmental budgets and company level multi-year business plans for the Clinical Pharmacology functional area.
  

Working at Alexion!
The Highest Standards
By operating with the highest standards of ethics and integrity, we aspire to live up to the expectations of patients, physicians, and ourselves, and to earn trust in our communities.
Diversity
We encourage diversity of backgrounds and ideas. We genuinely care for and respect each other, working together as a high-performing team to deliver extraordinary results while embracing different perspectives.
Dedication
The dedication and passion of our employees enable us to stay focused on what matters most. We push ourselves to achieve the highest level of medical innovation, and to redefine what it means to live with a rare disease.
Hybrid Work
Expectation of working in the office 3 days a week statement: When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
Vaccination
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
Commitment to Diversity!
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.