Executive Director, Head of Clinical Science and Medical Writing

Executive Director, Head of Clinical Science and Medical Writing page is loaded## Executive Director, Head of Clinical Science and Medical Writing locations:
Americas, US-PA, King of Prussia, CSL Behring:
EMEA, CH, Kanton Zurich, Opfikon, CSL Vifor:
EMEA, GB, Berkshire, Maidenhead, CSL Behring:
Americas, US-MA, Waltham, CSL Behring time type:
Vollzeitposted on:
Heute ausgeschriebenjob requisition :
R-260569

CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we’re building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.
** Your role
** The incumbent will be responsible for the quality and delivery of high-quality clinical development documents and oversight of clinical study delivery across the portfolio in collaboration with strategic CRO partners. Responsible for overseeing the recruiting, staffing and development of the clinical scientists and medical writing specialists in the group.
** Your responsibilities will include
** Oversight of Individuals
* Recruiting, staffing, training and development of clinical scientists and medical writing specialists in the group, to maintain a dynamic and cutting-edge level of medical scientific expertise and advanced drug development approaches

Ensuring delivery of high-quality clinical development content including:
* Clinical development plans, protocols, study reports, common technical document modules and publications in academic journals
* Regulatory submissions and meetings
* Stage-gate and benefit –risk evaluations and assessments
* Presentations at scientific and technical review committees
* Implementation of clinical recommendations from all advisory and governance committees

Internal interfaces and collaboration
* Member of the Clinical Development Leadership Team
* Will be responsible for managing a team of approximately 50 Scientists .
* Oversight of and collaboration with partnering functions, e.g. Clinical Operations, Research, GRA & Safety to assure an effective project related deliveries
* Participate and/or lead enterprise initiatives
* Maintaining effective oversight of quality in conjunction with appropriate Quality functions

External-scientific
* Enhancing the reputation of the Company through a culture of scientific integration of the department with the scientific community and other partners through visible publication record, KOL interactions, presence at scientific conferences, membership of consortia and similar medico-scientific groups, builds networks with scientific experts
* Ensures that the patient and health-care provider voice is integrated into CSL’s development mindset

Building a culture of risk taking, innovation and peer review across the clinical function

Providing clinical scientific and medical writing leadership throughout CSLProviding support and insight into business development opportunities as required
** Your skills & experience
*** Graduate level degree (M.Sc, PhD, MD etc) preferred.
* 10 years+ of Pharma experience in clinical development
* Experience across all phases of development, FIH, POC, late-stage development and life cycle management.
* Strong track record of oversight of successful drug development programs
* Experience across a wide range of regulatory interactions e.g. filings, Ad coms etc
* Strong track record of leadership skills.
* High level of self-awareness and the awareness of personal impact
* Enhanced organizational awareness and the ability to interact and influence from the team level to senior management
* Succinct and clear communication style
* Extensive experience of leading teams and/or line managing a group(s)##
** Our Benefits
** CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees…