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Clinical Development Director

Actalent

Posted on Jun 7, 2022 by Actalent

Basel, Switzerland
Health Care
Immediate Start
Annual Salary
Contract/Project

Clinical Development Director

As a Clinical Development Director you will be accountable for the scientific and clinical strategy of assigned clinical trials, scientific monitoring, and reporting of quality data. Experience with Cardiometabolic diseases and Cardio outcome trials is needed to thrive in this position.

Main Responsibilities:

Provides clinical leadership, medical and scientific strategic input, and contributes to development of trial related documents (eg, CTPs, informed consent form, case report forms, data monitoring committee charters, data analysis plan, reports, publications) for assigned clinical trial(s) consistent with Integrated Development Plan (IDP);

Provides clinical and scientific input and contributes to clinical sections of trial and program level regulatory documents (eg, Investigator's Brochures, Health Authority briefing books, safety updates, submission dossiers, and responses to Health Authorities);

Conducts ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s) with appropriate oversight from Medical Lead;

Manages patient safety reports on trial data to safety and clinical boards (eg, Safety Management Team (SMT), GCT, GPT) with appropriate oversight from Medical Lead;

Supports Clinical Development Head (CDH) with contributing to peer-review of IDPs, CTPs, and other clinical documents across various indications and programs

Contributes to medical/scientific training of relevant stakeholders on the disease area and compound/molecule;

May serve as speaker for franchise medical/scientific training.

Requirements:

10+ years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases (I to IV) and conducting clinical trials;

Conducting clinical trials in a global/Matrix environment in pharmaceutical industry;

Advanced degree in life sciences/healthcare (or clinically relevant degree) is required. PharmD, or PhD strongly preferred;

Working knowledge of the assigned disease area is desired with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) or program level;

Demonstrated ability to establish effective working relationship with key investigators;

Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes

Job Title: Clinical Development Director

Location: Basel, Switzerland

Rate/Salary: .00 CHF Hourly

Job Type: Contract

Aerotek and Actalent Services, an Allegis Group company. Allegis Group AG, Basel, Switzerland. Registration No. CHE-101.865.121. Aerotek and Actalent Services are companies within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, Actalent Services, Aston Carter, EASi, TEKsystems, Stamford Consultants and The Stamford Group are Allegis Group brands. If you apply, your personal data will be processed as described in the Allegis Group Online Privacy Notice available on the website.

To access our Online Privacy Notice, which explains what information we may collect, use, share, and store about you, and describes your rights and choices about this, please go to the website.

We are part of a global network of companies and as a result, the personal data you provide will be shared within Allegis Group and transferred and processed outside the UK, Switzerland and European Economic Area subject to the protections described in the Allegis Group Online Privacy Notice. We store personal data in the UK, EEA, Switzerland and the USA. If you would like to exercise your privacy rights, please visit the "Contacting Us" section of our Online Privacy Notice for details on how to contact us. To protect your privacy and security, we may take steps to verify your identity, such as a password and user ID if there is an account associated with your request, or identifying information such as your address or date of birth, before proceeding with your request. If you are resident in the UK, EEA or Switzerland, we will process any access request you make in accordance with our commitments under the UK Data Protection Act, EU-U.S. Privacy Shield or the Swiss-U.S. Privacy Shield.

Reference: 1621372951

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