Requisition ID 28304
– Posted 04/22/2022
– Country (Multi Selection) (1)
– City (Multi Selection) (1)
– Clinical Development Some opportunities happen only once in a lifetime
– like a job where you have the chance to change lives.
At Alexion, people living with rare and devastating diseases are our Guiding Star.
We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives.
We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.
Senior Director, Clinical and Non-Clinical Pharmacology This is what you will do: Lead a team of clinical pharmacologists and provide 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.
The responsibilities also include managing company’s technical and strategic needs for conducting in-licensing activities.
You will be responsible for ensuring Clinical Pharmacology support and is expected to actively participate in the key decisions at the R&D governance milestones.
At the non-clinical stage, you will be responsible for providing leadership on key milestones up to IND filing by collaborating with toxicology, biomarker and pharmacometrics functions to enable selection of dose/regimen for FIH studies for all research programs.
At the clinical stage, you will be responsible for authoring and strategizing clinical pharmacology development plans, identifying Phase 2/3 dose regimens by collaborating with other Translational Sciences/Medicine disciplines, providing strategic direction to the writing and review of reports and integrated summaries submitted to the regulatory authorities and interacting with the regulatory authorities.
The responsibilities also include managing the department resources and budgets.
At the enterprise level, the expectation is to provide leadership in cross-functional collaboration on companywide initiatives related to productivity, innovation, or efficiency.
You will be responsible for: Providing clinical pharmacology leadership on the project team(s), individually and through direct reports, and collaborating across other development functions 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.
Getting buy-in from project teams, as well as participating in discussions and presentations to senior management Directing/executing non-clinical activities up to IND and supporting internal go-no-go milestone 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 Directing/executing clinical activities post IND up to registration; and supporting internal go-no-go milestone 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 Leading and ensuring selection of dosing regimen for nonclinical studies and FIH studies during the pre-IND stage and leading the selection of dose for Phase 2/3 studies by ensuring integrated data analysis support Managing the company’s technical and strategic needs for conducting in-licensing activities.
You will need to have: Doctoral degree (PhD or national Equivalent) in pharmaceutical sciences, or relevant discipline.
PhD in field related to Pharmacokinetics and 15 yrs of industry experience in Drug Development.
Excellent verbal articulation and technical writing communication skills.
Advanced knowledge of and hands-on experience in 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.
Proven track record of leading oral presentations to the global regulatory agencies.
Proven track record of 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.
Established track record of leading team(s) of scientists and mentoring direct reports in Clinical Pharmacology.
Proven record of simultaneously managing and completing multiple complex projects independently and through direct reports.
Established track record of scoping and executing due diligence activities at all stages of development.
Experience in executing strategy and operational aspects of mergers and acquisitions.
Strong communication, leadership, and people interaction skills, while working in a highly matrixed environment.
The duties of this role are generally conducted in an office environment.
As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
We would prefer for you to have: Knowledge in managing departmental budgets and company level multi-year business plans for the Clinical Pharmacology functional area.
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines.
Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries.
Further information about Alexion can be found at: www.alexion.com .
Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer.
We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness.
The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law.
Alexion provides reasonable accommodations to meet the needs of candidates and employees.
To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodationsAlexion.com.
Alexion participates in E-Verify.
AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease.
If you’re interested in career opportunities with AstraZeneca, click here .