Global Clinical Development Director, Dermatology

Location: Barcelona, Spain
Job Type: Permanent
Specialisation: Life Sciences
Salary: excellent package and relocation available
Reference: 75223-PHARM-VLB_1569950127
Contact: Vladyslav Babych
Email: email Vladyslav

A successful and highly recognised specialist Pharma company continues their ongoing commitment to expanding a clinical development pipeline and is looking to bring on board high calibre pharmaceutical physician with management and global clinical development expertise.
The major objectives will be: to manage group of global clinical leads and scientists, to lead the clinical development strategy and oversee operations of clinical development for the project(s) assigned. Leads the medical sub team for the corresponding project.


Mission

Lead the clinical development strategy and over sees operations of clinical development for the project(s) assigned. Leads the medical sub team for the corresponding project.

Accountable for high quality, timely and cost-efficient execution of the clinical development programs

  • In close alignment with the Head of Clinical Development and other R&D Leadership team members, drive the operational execution of the clinical development plans

  • Actively monitor the portfolio, identify risks and implement preventive and corrective actions as indicated

  • Lead special strategic projects as needed


Tasks and Responsibilities

  • Defines the objectives, strategy, milestones and resources required for clinical development, at least up to registration in line with the TPP and Target Product claims.

  • Day to day management and support of Global Development Team Members

  • Leads/chairs the Medical Sub Team (MST).

  • Provides guidance to Clinical Study Teams to ensure alignment of clinical trials planning and conduct with the overall development strategy.

  • Defines protocol outlines.

  • Ensure s/he is knowledgeable about both clinical safety and efficacy aspects of the product under development and seek internal or external advice as appropriate.

  • Review and approves clinical content for key internal or external project related documents (e.g. IB, briefing package for regulatory authorities, ISE, ISS, publication protocol, SAP, CSR).

  • Identifies and manages the Clinical risks and opportunities.

  • Primary contact for Global Marketing & Medical Affairs to define the Market Access needs and clinical differentiation strategy.

  • Participate in the selection of CROs for clinical studie.

  • Ensure rigorous adherence to quality and compliance

  • Development methodology for programs with new indications or new disease areas

  • Dose selection strategy for first-in-human studies

  • Biomarker development and selection for early and late stage (Phase I-III) programs




Requirements for the position:
Qualifications:

  • Full Medical Doctor Qualification from recognised institution

  • Board Certification in Dermatology or significant experience in this TA

  • Alternative specialisation in Immunology or Internal Medicine will suffice if accompanied by significant clinical and/or industry exposure to Dermatology TA



Skills and Experience:

  • Excellent knowledge of Dermatology

  • Proven track record of Medical/Clinical leadership and personnel management

  • Medical Training or Experience of managing Program Teams is preferred

  • Clinical background relevant to the Portfolio (Dermatology or Immunology) preferred

  • Strong knowledge of clinical development methodology.

  • Deep understanding of the scientific and biostatistical data.

  • Proven ability to provide strategic and medical oversight to phases I, II, III of global clinical trials.

  • Leadership and team work.

  • Multicultural communication.

  • High presentation skills

  • Strong verbal and written communication in English is must