Senior Director, Rare Oncology

Senior Medical Rare Oncology

Location : Barcelona, Spain

Barcelona, Spain

Reports To :

Vice President, Clinical Development, NF1 & Bone Metabolism, Alexion and dotted line to the Head of External Scientific Engagement

This is what you will do :

The Senior DirectorRare Oncology is responsible for overseeing 2 or more programs, providing oversight / guidance / mentoring to the Clinical Development, Clinical Operations and business development organizations, serving on cross-asset strategic teams (e.

g., disease strategy team) and providing input to strategic decisions at the Therapeutic Area (TA) Strategy Team and Global Medicine Team meetings.

Manages Associate Directors and clinical scientists directly and may support / oversee other staff within the TA. Provides overall support to regulatory strategy and commercial strategy when required.

The Senior DirectorRare Oncology is also responsible for early identification of Key HCPs networks for indications (at the Global level), setting up & maintain robust relationships with Global Strategic Consulting Groups in key areas of interest, and working cross-functionally with all relevant internal stakeholders (COM, ClinDev, ClinOps, PAG, Reg, Access.

to define SCG agenda and key questions to address / insights to collect.

He / she will also establish Strategic Scientific Engagement Plan for the MACT (Medical Advisor Clinical Trials) Team : drive MACT local execution, studies prioritisation (with COM & MACT), collaborate with MACT Study Lead to create appropriate material, and define Strategic Engagement Plan at national / regional level.

You will be responsible for :

Typically lead 2 program teams and drive the successful execution of clinical studies / programs / research strategies;

define and manage the benefit to risk profile of our products.

Representing Clinical Development on the Global Program Team (GPT) and Global Medicine Team in presentations at management and review committees (e.

g., Clinical Document Review Committee, Development and Commercial Steering Committee); advance understanding of the impact our therapies have on the pathophysiology of rare and orphan diseases through scientific discourse and interpretation of data.

• Fostering the development of Medical Directors and Clin Dev Scientists and / or fellows. Leading and overseeing 2 programs and the preparation and execution of a clinical development strategy and related documents including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents.
• Providing scientific and medical input (consultative services) to other R&D, commercial, translational, medicine and business development functions and leads and or oversees clinical activities to support due diligences.
• Act as an expert consultant on
• to the Vice-President and Therapeutic Area Head, as well as to other Senior Executives in Alexion and AstraZeneca
• Representing Alexion Clinical Development in to Key External Stakeholders & Patients Associations.
• Establishing & maintaining close relationship with relevant Global Consulting Groups & driving proper execution of External Scientific Engagement Plan at Regional / National level with MACT team.
• Representing Alexion Clinical Development to internal (R&D management, cross-functional development teams and executive committee) and external (academic, regulatory, and medical) communities.
• Overseeing a cross-functional team which develops the clinical components of the Clin Dev Plans. Serve as the Clinical input to Global Development Team / Subteams and medical expert for the clinical study teams.

Oversees the writing of the clinical sections of the CTD, white papers, expert opinion reports, and regulatory responses.

Liaising internally with other members of the CDP to drive program strategy and CDPs. Coordinate communications and planning bet medical functions (Global Medical Affairs, Safety, Clinical Operations, Biostatistics, Epidemiology and Medical Science) as it relates to clinical development study design, execution, and interpretation of results.

Serves as the medical expert on the global product labelling team

• Driving awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review
• Writing or contributing to white papers, expert opinion reports, and regulatory responses
• Driving clinical support of business development activities, such as due diligence and research collaborations
• Critically evaluate available information about diseases of interest to the therapeutic area and the competitive landscape and synthesize information succinctly to support dissemination and incorporation into clinical development programs, asset plans and therapeutic area strategy
• Determining appropriate advisory boards experts
• Working as part of a cross-functional team with colleagues representing, for example, biostatistics, data management, clinical pharmacology, commercial, regulatory and project management
• May supervise medical monitors on individual studies

You will need to have :

• MD with 7+ years of experience in clinical practice in Oncology or related disciplines and clinical research
• Exposure to regulatory interactions, such as having prepared documents and attending regulatory meetings with FDA, EMA or other regulatory agencies
• Participation in Advisory Boards / Committees
• Experience designing and executing multinational clinical trials required
• Demonstrated ability to lead cross-functional teams
• Experience supporting business development activities
• 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 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 :

• High level degrees such as PhD or MSc in related discipline
• Understanding of basic statistics and clinical data management / interpretation

Date Posted

29-Jan.-2024

Closing Date

30-März-2024