Manager Clinical Science

  • Alvotech
  • Zürich, ZH, Switzerland
  • 17/07/2020
Full time Data Science Data Analytics Big Data Statistics

Job Description

About us

ALVOTECH
Alvotech is a privately owned, fully integrated specialty biopharmaceutical company focused exclusively on the development and manufacturing of high-quality biosimilar products, all along the value chain from cell line development to commercial manufacturing. The company is well on its way to becoming a global leader in the biosimilar space and is helmed by an outstanding management team and prestigious group of shareholders.
Alvotech prides itself on attracting highly experienced industry talent, drawn by its purpose-driven culture. With its strong emphasis on excellence and commitment to improving the lives of patients by making biologics more accessible around the globe, Alvotech strives to promote a culture of diversity and inclusion.


See more at Alvotech.com

Location

Zurich, Switzerland

Role Overview
  • The Manager Clinical Science will support the Senior Manager Clinical Science and Vice President (VP) Clinical Development with strategic planning and preparation of Clinical Development Plans (CDPs) and Target Product Profiles (TPPs).
  • The Manager Clinical Science will report to and will be supervised by the Senior Manager Clinical Science, within the CMA Department.
  • Within his/her function, the Manager Clinical Science will contribute to ensure state of the art medical/scientific input into all relevant clinical and regulatory documents, and is expected to interpret and present clinical trial results for assigned clinical programs/trials.
  • In addition, the Manager Clinical Science will also be expected to provide scientific support throughout conduct of assigned clinical trials; respond to clinical questions from different sources
  • Further, the Manager Clinical Science is expected to support the VP Clinical Development and/or Safety-Pharmacovigilance Officer in respect to clinical safety and pharmacovigilance (PV) activities.
  • For this role, previous experience in clinical drug development and a strong scientific background (preferably in immunology and/or oncology), is required. Experience with biologicals will be a definitive plus.
  • The Manager Clinical Science should be able to work independently as well as feel comfortable being part of a multifunctional team. Therefore both self organizational and interpersonal skills are required for this role.
  • Knowledge and understanding of the International Conference of Harmonisation-Good Clinical Practice (ICH-GCP) environment is also requirement for this role.
  • The primary location for this role is Alvotech‘s office in Zurich. It is expected that Manager Clinical Science will have to travel internationally.
  • Essential Job Functions

Examples of main responsibilities for the Manager Clinical Science are to:

  • Contribute to medical/scientific input for the preparation and review of synopses, protocols, clinical trial reports, relevant sections of Investigational Medicinal Product Dossier (IMPD), Investigator’s Brochure (IB), safety reports, briefing documents, INDs, NDAs, and other regulatory documents for the assigned clinical trials/projects.
  • Provide scientific support throughout conduct of assigned clinical trials; respond to clinical questions from clinical sites, Independent Review Boards (IRBs), Health authorities and Contract Research Organizations (CROs).
  • Review clinical trial data, interpret and present for further discussions, both internally and externally.
  • Contribute to the review of the data coding using MedDRA and WHO drug classification.
  • Contribute to the clinical and pharmacovigilance databases reconciliation.

In his/her role, the Manager Clinical Science is expected to:

  • Contribute state of the art scientific/medical input into overall clinical development strategy, clinical trial designs and any clinical and regulatory documents for the assigned projects.
  • Ensure adequate medical monitoring of assigned clinical trials.
  • Support pharmacovigilance activities to fulfill all regulatory and medical requirements for the assigned clinical programs/trials.
Key Responsibilities and Work assignments

Typical responsibilities and work assignments are to:

  • Provide input into CDPs and TPPs.
  • Provide clinical/scientific input during the development and execution of assigned clinical trials.
  • Interpret clinical trial data of assigned clinical trials.
  • Provide safety assessments for assigned clinical trials.
  • Participate in interactions with regulatory authorities.
  • Keep his/her training record up to date.
  • Be up-to-date with ICH-GCP requirements.


Language Skills:

  • Fluent in English, both written and verbal. Any additional language is a “nice to have“.

Computer Literacy:

  • Proficient in use of a PC and common Microsoft packages such as Word, Visio, Excel, Powerpoint.

Organization and Management Skills:

  • Will be required to coordinate, participate and make positive contribution to team meetings. Responsible for individual performance management.

GCP Experience:

  • Will be expected to understand and comply with GCP requirements as well as Alvotech‘s relevant Policies, Standard Operating Procedures (SOPs) and Work Instructions (WIs).
  • Will participate in internal and external audits as well as regulatory inspections.

Collaboration and Interpersonal Skills:

  • Expected to build team spirit, be tolerant and considerate, be an active and open communicator and share knowlege and experience with other team members. Flexibility to work with colleagues in a global setting.

  • Competencies required to fulfill the employee responsibilities and work assignments:
  • An employee shall follow the job description that pertains to his/her position. In addition an employee shall follow the SOPs that pertains to his/her position.
  • An employee shall adhere to the company etiquette in all matters of behavior and manners. The employee shall take the initiative when solving a task assigned to him/her and do whatever is necessary to solve it.
  • It is important that an employee has the company values at heart in his/her work.
  • An employee shall be actively involved in tasks that involve other departments in the company, in addition to other tasks assigned to him/her.
  • Additional competencies required to fulfill key management responsibilities:
  • Managers are always responsible for following the procedures that the company has established regarding environmental, health and safety issues.
  • Manager is responsible for the conscientious and efficient operation of his department and the training of his staff.
  • He is under obligation to follow developments in comparable fields and to seek solutions that boost the performance of his workforce and decrease the company’s overall costs.
Your profile

Education: (Minimum)

  • Master in life sciences or equivalent.
  • (Strongly desired) M.D., Pharm.D., Ph.D. or equivalent.

Experience:

  • 3+ years in relevant functions in the Pharmaceutical Industry, or equivalent.
  • Strong scientific background (preferably in immunology and/or oncology).
  • Experience with biologicals.
Why us?
  • Alvotech is a multinational workplace with employees from all over the world, benefitting from the diversity and the great talent that all of the employees bring into their work.
  • Alvotech is a dynamic company that is expanding and growing at a fast pace which involves a lot of growth opportunities for employees within the company.
  • Alvotech‘s working environment is friendly and full of energy, employees maintain their good energy by enjoying gourmet bistro at lunchtime; a professional coffee bar and a fully equipped gym with classes thaught daily.
  • Alvotech has an active social life that is highly appreciated by the employees, managed by a group of employees that plan all kinds of fun events.
  • Alvotech is committed to being at the cutting edge of technology by using some of the best equipment and processes in the industry. With the core mission of improving people´s lives by providing live changing treatments to patients worldwide, the purpose of all Alvotech employee´s work is clear.
  • Alvotech already has a powerful group of people that are experts in their fields and we are excited to have more great colleagues to join us.
Contact information

It is requested that the applicant is able to start work at the earliest possible convenience. All applications will be handled as confidential