Global Development Scientist Director (Alexion)

Global Development Scientist Director is an important part of the Clinical Project Team (CPT) and Global Study Team (GST) working synergistically and cross functionally (in a matrix environment) with other CPT & GST members Site Management & Monitoring (SMM) fieldbased liaisons and site personnel. The Global Development Scientist Director and counterpart Global Development Medical Director work collaboratively in the clinical aspects underpinning a clinical program. This includes the shared responsibility with Clinical Operations team members in the planning and execution including recruitment and delivery of a clinical study. Accountabilities include clinical support for the development and implementation of Alexion sponsored clinical program strategies. This includes providing clinical input into design & implementation of clinical trial(s) their delivery clinical data review interpretation of results reporting successfully on time and activities for worldwide registration of the product (i.e. clinical input to NDA/BLA).

The Global Development Scientist Director may also provide expert input or lead functional process improvement initiatives and provide contributions to cross asset or cross tumor area working groups depending on the level of experience.

As a key member of the clinical team this position demands strong collaborative communication skills including the ability to engage with and influence a diverse range of stakeholders both within and external to Alexion. The individual 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.

Depending upon experience level the role will mentor the development of less experienced members of the clinical team.

You will be responsible for:

Clinical Development Responsibilities/Accountabilities

• Work cross functionally within clinical project team (CPT) to ensure the clinical strategy is translated into the development of the study concept document study protocol and related documents (such as Global ICF CRF TFL shells etc).

• Develop relationships with appropriate consultants and key external experts (KEE) study sites and utilize these relationships to obtain feedback on protocol design as well as study training study execution and interpretation of study results.

• Responsible for the relevance and accuracy of clinical science underpinning of clinical study based on detailed scientific review and and consultation.

• Responsible for the clinical and leadership and integrity of protocols and/or components of clinical plans.

• Supports or leads interactions with global medical affairs marketing companies commercial and regulatory functions in collaboration with GCH/GCPL to ensure cross functional input into protocols.

• Contributes to technical review of protocols with governance bodies such as DRC and PRC.

• Support Health authority interactions as needed.

• Contributes to the development of Medical Oversight Plan (MOP)

• Contributes to study level safety reviews

• Contributes to studylevel medical monitoring activities

• Contribute to the timely initiation and delivery of clinical trials in close collaboration with Clinical Operations and other CPT/GST members (including supply chain and sample management).

• Core member of the GST representing Clinical Development.

• Responsible for the clinical input into Feasibility Questionnaires and consulted on country and site

• Responsible for the clinical and scientific input into a study and for the quality of the clinical data

• Responsible for timely responses to investigational study sites for local ICF changes protocol & EC/IRB questions/requests

• Contribute to advisory boards to ensure there is engagement with site specific KEEs to ensure robust study designs recruitment strategies.

• Through strong partnerships with Clinical Operations (including Program Management GSTs SMM and investigational sites) proactively flag recruitment risks with proposed mitigations and support implementation of mitigations in a timely fashion.

• Proactively engage with MSLs to build strong partnerships with SMMs and KEEs to provide robust feasibility assessments and streamline study execution.

• Contribute to development and delivery of face to face or virtual investigator and monitor training.

• Contributes to the review and interpretation of clinical data (HLRs) and the development of content needed for governance committee interactions seeking Go/No Go decisions.

• Support the development of clinical components of regulatory and EC/IRB submission documents for instances where marketing approval is warranted.

• Contributes to development and delivery of the clinical study report.

• Work cross functionally in the preparation of launch & branding materials and publications.

• Where appropriate serve as a mentor of less experienced staff.

You will need to have:

Technical Skills:

• Drug Development/Clinical Development Planning: Demonstrates the ability to undertake the planning and timely organization of components of the clinical development plan and work with other functions to achieve successful study initiation and execution.

• Ability to drive/contribute to protocol design writing and implementation to meet GCP ICH and all Alexion quality standards.

• Demonstrates solid understanding of methodology in the design conduct review and interpretation and presentation of clinical research.

• Can conduct literature reviews to inform protocols and author background sections on the disease or current medical therapy.

• To provide clinical input into options for the study design and development of the statistical analysis plan.

• To effectively organize content and rationales in assigned sections of clinical reports or regulatory/EC/IRB documents (i.e. CTA briefing book BLA/NDA)

• Emerging communication & presentation skills to communicate scientific concepts/data clearly and crisply in team settings and in formal presentations to leadership committees (e.g LSPC DRC PRC) or external groups (e.g Investigator Meetings IDMCs Conferences Presentations).

• Emerging leadership skills in individual and team settings to influence others and drive consensus building where needed.

• Ability to contribute to clinical reports and integrated summary reports.

We would prefer for you to have:

Education Qualifications Skills and Experience

• Required Life Sciences degree or equivalent

• PharmD Ph.D. degree in life sciences or MD. Oncology experience is a plus

• Industry or academic experience in drug development .

• Possesses detailed knowledge of Good Clinical Practice (GCP) and other regulations governing clinical research.

• Possesses general knowledge of 1) medical monitoring 2) Regulatory approval process in relevant countries; 3) pharmaceutical industry/R&D operations; 4) marketing and commercial fundamentals.

• Ability to grow and maintain a high level of expertise in oncology therapeutic area.