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Lead Medical Director, Product Development, Cardiovascular Metabolic

Lead Medical Director, Product Development, Cardiovascular Metabolic

Genentech, IncBasel
We advance science so that we all have more time with the people we love.Roche’s Clinical Development organization is structured by therapeutic area and is responsible for developing and executing ...Voir plusDernière mise à jour : il y a plus de 30 jours
Packaging Operator

Packaging Operator

DEKRA Arbeit Schweiz AGBasel, Basel-Stadt, CH
Quick Apply
We are looking for a detail-oriented.You’ll work in a GMP-compliant cleanroom environment, ensuring products are accurately packaged and labeled for distribution. Operate and monitor packaging machi...Voir plusDernière mise à jour : il y a 16 jours
QA Manager GMP / GDP

QA Manager GMP / GDP

CTCBasel and NW Switzerland, CH
Provide GMP / GDP quality assurance expertise during development and commercialization of client’s products.Ensure all required quality activities are initiated and completed according to the develop...Voir plusDernière mise à jour : il y a 2 jours
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(Senior) Consultant Qualification & Validation

(Senior) Consultant Qualification & Validation

WhatJobsBasel, Basel-Stadt, Schweiz
Senior) Consultant Qualification & Validation.Be among the first 25 applicants.Senior) Consultant Qualification & Validation. Arcondis is a global consulting company with an exclusive focus on the h...Voir plusDernière mise à jour : il y a 10 heures
Clinical Trial Supply Manager (CTSM)

Clinical Trial Supply Manager (CTSM)

headcount AGBasel, Switzerland
Clinical Trial Supply Manager (CTSM) .We are supporting a biotech company with a strong global presence in the search for a Clinical Trial Supply Manager. This person will take ownership of supply ...Voir plusDernière mise à jour : il y a 23 jours
Senior DevOps Engineer

Senior DevOps Engineer

RandstadBasel-Stadt, Basel, Switzerland
Are you a seasoned DevOps Engineer with a profound understanding of CI / CD, automation, source control systems, and packaging and deployments? Additionally, do you possess coding experience with C++...Voir plusDernière mise à jour : il y a 1 jour
IMP Quality Manager (m / f / d)

IMP Quality Manager (m / f / d)

ITech Consult AGBasel
IMP Quality Manager (m / f / d) – pharmaceutical / cGMP / SOPs, master batch records, discrepancy and change records and validation reports / parenteral IMPs (e. EU Annex 1) / CAPA / Veeva Vault / SAP / MES...Voir plusDernière mise à jour : il y a 28 jours
Senior Sales Executive - ServiceNow DACH (m / f / d)

Senior Sales Executive - ServiceNow DACH (m / f / d)

DXC TechnologyBasel,Switzerland,SW
DXC Technology (NYSE : DXC) helps global companies run their mission-critical systems and operations while modernizing IT, optimizing data architectures, and ensuring security and scalability across...Voir plusDernière mise à jour : il y a 28 jours
Medical and Pharmaceutical Packaging

Medical and Pharmaceutical Packaging

Gi Group SABasel, Basilea Città, Schweiz
Quick Apply
Für unseren international agierenden Kunden im Bereich Pharma-Verpackungen (Region Basel) suchen wir zum nächstmöglichen Zeitpunkt einen. Category Manager Raw Materials.Einkauf von Rohstoffen mit st...Voir plusDernière mise à jour : il y a 28 jours
Clinical Packaging Operator (m / w / d), 100%

Clinical Packaging Operator (m / w / d), 100%

EDP Personalberatung GmbHBasel-Stadt, Riehen, Switzerland
Clinical Packaging Operator (m / w / d), 100%.Führt die Primär- und / oder Sekundärverpackung von klinischen Fertigprodukten für klinische Studien (z. Führt die erforderlichen In-Prozess-Kontrollen (IPC) ...Voir plusDernière mise à jour : il y a 6 jours
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Lead Medical Director, Product Development, Cardiovascular Metabolic

Lead Medical Director, Product Development, Cardiovascular Metabolic

Genentech, IncBasel
Il y a plus de 30 jours
Description de poste

We advance science so that we all have more time with the people we love.

The Opportunity

Roche’s Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late development (Phase II – III) clinical strategies and plans that deliver medically-differentiated therapies that provide meaningful improvement to patients. The Lead Medical Director makes major contributions to development of the Clinical Development (CD) strategy and plan and is responsible for effective and efficient execution for the assigned molecule(s) / indication(s).

You will support the development and implementation of the Clinical Development Plan (CDP) for assigned molecule(s) / indication(s); gathering and analyzing data and information necessary to create the CD plan.

You will collaborate with a variety of internal / external partners & stakeholders, as well as multidisciplinary internal groups, including business development, research, commercial, legal, etc.

You may participate in meetings, reviews, discussions and other interactions regarding early development / Phase I studies to provide clinical science input & guidance; including reviewing and providing late stage input to Phase I & II protocols.

You have a demonstrated understanding of Phase II - III drug development.

You will take an active role with other CST members, regulatory and other internal partners / stakeholders in the completion and submission of regulatory filings and other regulatory documentation. Provides clinical science information and input for regulatory submissions and other regulatory processes. Includes developing label and packaging language, etc.

You will be responsible to ensure strategic and operational alignment of the CD plan with the relevant CD strategy, strategic and annual LCP; you will work with other CST members and relevant sub-teams to develop CD plan components (e.g., analytics / data strategy, KOL development, publications strategy, etc.)

This position is based in South San Francisco, CA, (USA), Boston, MA (USA), Welwyn, UK or Basel, Switzerland.

Relocation benefits are not being offered for this position.

Who You Are : Required)

You have an MD / MBBS, MD / PhD, 3+ years clinical experience; Board Certified training in areas of the Cardiovascular, Renal, Metabolic (CVRM) space preferred

You have significant experience working with the principles and techniques of data analysis, interpretation and clinical relevance.

You have 4+ years of pharma / biotech late stage clinical development experience.

Preferred :

You have demonstrated experience as a clinical development lead; you have the proven ability to use sophisticated analytical thought, identify innovative approaches and act a mentor.

You have demonstrated experience working with various clinical trial designs, (e.g. accelerated approval, pivotal, breakthrough etc)

You have sound knowledge of the pharma / biotech industry, the multiple functions and roles involved in the drug development process.

You have the ability to collaborate with relevant team members to measure and monitor study progress against objectives and plans, including any variances, and proactively communicate any issues, challenges and potential strategies to resolve such

You have strong interpersonal skills : Outstanding interpersonal, verbal, and written communication and influencing skills : has built and cultivated important relationships both inside an organization and externally. Has proven abilities to influence internal partners and stakeholders, thought leaders, national advocacy organizations, national standard-setting bodies, and other relevant external parties. Seamlessly collaborates with colleagues / other parts of the organization.

Relocation benefits are not being offered for this position.

The expected salary range for this position based on the primary location of South San Francisco, CA is $233,500 - $433,600. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

This position also qualifies for the benefits detailed at the link provided below.

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form .