The Gobal Medical Director Established Products (GMD/GSD-EP) assumes the PD Medical Affairs (PDMA) strategic lead for a Roche product/group of products which are late in their Lifecycle stage.
PDMA EP is a team of medical and scientific experts responsible for a group of products in more than 10 therapeutic areas and is dedicated to maximize EP medical value for patients in collaboration with other PD, GPS functions and Roche affiliates. The role requires Pharma business and regulatory understanding and broad scientific and therapeutic area expertise, to identify and address the relevant medical needs ensuring optimal use of Roche products in clinical practice.
The GMD/GSD-EP is a member of the Established Products Medical Team as well as of one or more cross-functional Established Products Teams (EPT).
The incumbent in this role:
*Is responsible for or contributes to (depending of the product portfolio) developing and implementation of medical strategy & tactics and ensuring alignment with the overall brand strategy in collaboration with International Portfolio Leader.
*Is the company's medical & scientific expert for the assigned product(s), who provides expert input for the internal and external stakeholders (e.g. to address Regulatory Authority requests).
*Stays abreast of internal and external developments and trends to maintain a fully up-to- date view of internal/external context for the assigned product(s) to ensure optimal medical affairs response in addressing patient needs.
*Ensures effective and efficient use of resources and acts in line with legal, regulatory and company's standards and codes of practice.
To be successful in this role, your profile and qualifications include:
*University Degree in Life Sciences (required), an advanced Clinical/ Science Degree (preferred) (e.g., MD, PharmD, PhD, etc.) with several years' experience in pharmaceutical industry, in medical function at global or country level preferably in the areas of oncology, immunology.
*Experience and strong knowledge of the overall drug development process.
*Experience of development of insights driven medical strategy & tactics, before and after product launch, including medical communications, patient/HCP engagement as well as design and conduct of clinical trials; authoring experimental protocols and/ or study results and conclusions.
*Proven expertise in dealing with wide range of data/ information and developing/ responding to various requests: clinical safety/ regulatory/ legal, etc.
*Considerable experience in external collaboration & stakeholder management: TAEs as well as consultants, contractors and agencies.
*Excellent collaboration, communication and presentation skills, fluency in English is required, additional languages are advantageous.
*High self-motivation, ability to work autonomously and as part of a cross-functional team
*Track record of making decisions and aligning the organization behind them.
*Experience of writing clinical publications, Expert Reports and other regulatory documents such as PBRER and DSUR, etc. Because of the international scope of this position, you should be willing to undertake the associated travel.
Please contact Mark Cussens, Clinical Research Recruiter on
Tel: +41 4350 86620 or email: firstname.lastname@example.org
You MUST be eligible to work in Switzerland. Learn more
- Agency: Key People
- Reference: mc 24333
- Posted: 25th September 2020
- Expires: 23rd October 2020