Senior Director, Global Program Team Leader

Reporting to the TA Head, theSD, GPTLis responsible for providing strategic direction and leadingtheglobaldrugdevelopment withonelate stageasset thatcanhave multiple indications indevelopment, (or two early assets in differentindications).

As the accountable program(s) owner, the GPTL, leads and chairs the GlobalProjectTeam (GPT), whichdeterminesthe overall strategy for the asset/sacross indications.  

The GPTisresponsible forcreatingan integrated development plan for eachindicationand overseeingtheprogram.TheGPTLis the “one voice” for theGPTup the line (R&D Leadership, Development Steering Committee and Executive Steering Committee).The GPTrole is one of leadership, being proactive and interactive, andemphasizingpartnership with allGPTmembers andProjectSub teams, functional headsand consultants both within,and outside R&D. TheGPTLshould stimulate creative and productive discussion, motivate, ownership and urgency (when necessary) as well as robust discussions of risk identification and mitigation opportunities, and ensure clarity of purpose and responsibilities with theGPT. TheGPTLhas the negotiation and persuasion skills necessary to ensure theprogram's successand sets goals for the GDT and specific program-related goals for the Core Team members.

You willbe responsible for:

TheGPTLis accountable for:

• Program ownership with final accountability forprecisedefinitions of program goals, plans,decisionsand deliverables to meet those goals

• Responsible for developing the overall asset strategy, includingindicationsequencingand theoverall regulatory and CMC strategy to supportallthe indications underdevelopment.

• Providestrategic direction and leadership to the GPTs to ensureprecisegoal setting and robust development plansfor effectiveand efficient development of the asset overall.

• Ensures that theGPT, functionalsubteamsand GPT membersimplement plans and adhere to key development milestones for assigned projects.

• Contributes to objective setting and appraisal of core team members forprogram-relatedactivities

• Keeps senior management informed

• Ensureshigh-performanceteam effectiveness

You will need to have

• Total leadership experience including line/project management, multidisciplinary program management experience, which includes leadership in more than one IND/IMPS, BLA/NDA/MAA, Advisory Committee or other PMDA/EMA/FDA meetings.

• Minimum offive(8) years of experience in drug development in pharmaceuticals, biopharmaceuticals, or biotechnology.

• Demonstrated experience leading the development of at least one development candidate with adherence to quality,excellenceand efficiency.

• Demonstrated experience leading drug development projects and activities in a matrixed, global organization.

• A broad understanding of how to communicate and work well with team members and relevant people as well as scientists and external decision-makers worldwide.

• A thorough understanding of how to influence local and global regulatory,scientificand commercial environments.

• Ability to assimilate data, recognize keyvariablesand analyze complex situations to substantiate strategic recommendations.

• Has a realistic expectation of the business,oneselfand others.

• A style which builds alliance within the organization, locally/globally, and/or corporate collaborators.

• Does not confuse effort for results.

• Tenacity to weather short-term setbacks for long-term advantages.

• Broad understanding of the multidisciplinary functions contributing to effective and efficient drug development.

• Solid understand of CMC, pharmacology, toxicology, PK, clinical requirements to support major regulatory filings – IND/IMPD, BLA/NDA/MAA

• Excellent understanding of the interdependencies of the various disciplines (e.g., CMC, Pharm/Tox, PK, Clinical, Regulatory, Marketing, Finance) – what needs to be evaluated simultaneously vs. sequentially etc. from a strategic planning/risk management time/event/cost point locally and globally.

• Has a firm understanding of how to educate/advise/operatewith respect to RegulatoryGuidances/Internal SOPs/Projectbest-practice behaviors.

We would prefer for you to have:

• An advancedlife-science degree (MD,PhDor PharmD) is preferable, with aspecialtyinEndocrinology,Metabolism,Rheumatology, Internal MedicineorClinicalPharmacologyor equivalent experience with global developmentrequired.

• Hands-on experience indevelopingbiologicalassetsin clinicalstage.

• Regulatory exposure to major agencies

• Excellent written/oral communication skills in English

• Attention to detail and ability to think strategically

• Willingness to take on new responsibilities

• Interest and ability to learn about new therapeutic areas

• Interest in career progression and ability to take on more senior roles in 1-3 years 

• The duties of this role aregenerally conductedin an office environment. As is typical of an office-based role, employees must be able, with or withoutaccommodationto: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

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.

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.