Executive Director, Head of Clinical Science and Medical Writing

Waltham, MA - USA

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

CSLs R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration were 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 CSLs development mindset

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

Providing clinical scientific and medical writing leadership throughout CSL

Providing support and insight into business development opportunities as required

Your skills & experience

Graduate level degree ( 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 ofleadership 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 at every stage of their life. Whether you are considering starting a family need help paying for emergency back up care or summer camp looking for mental health resources planning for your financial future or supporting your favorite charity with a matching contribution CSL has many benefits to help achieve your goals.

Please take the time to review our benefits site to see whats available to you as a CSL employee.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients needs by using the latest technologies we discover develop and deliver innovative therapies for people living with conditions in the immunology hematology cardiovascular and metabolic respiratory and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation recombinant protein technology and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 people and delivers its lifesaving therapies to people in more than 100 countries.

We want CSL to reflect the world around us

At CSL Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy we are able to better understand and connect with our patients and donors foster strong relationships with our stakeholders and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL.

Do work that matters at CSL Behring!

Required Experience:

Director