Job Detail

Associate Director Clinical Science (100%) M/F

Inseriert am: 17.05.2021

Vacancy details


General information


Reference

2021-83  

Information about Molecular Partners AG


Founded in 2004 by a group of PhD students as a spin-off from the University of Zurich, Molecular Partners AG is a thriving and steadily growing clinical stage biotech company located in Zurich-Schlieren (Switzerland) with 165 highly qualified employees.


In order to advance modern medicine and significantly improve the management of serious diseases, we have developed and successfully established a powerful new class of potent, specific and versatile small protein therapies, called DARPin® therapeutics.


The continuous development of a broad portfolio of therapeutic product candidates in oncology and ophthalmology based on the company’s proprietary DARPin® platform allowed a successful listing of the company on the SIX Swiss Exchange (ticker: MOLN). Next to our own pipeline of drug candidates we have entered into collaborations with leading international pharmaceutical companies, including Allergan, Amgen, Roche and Janssen Pharmaceuticals.


The highly dedicated, multi-disciplined team at MP is committed to developing breakthrough medicines for serious diseases.


Position description


Position title


Associate Director Clinical Science (100%) M/F


Job description


The Clinical Scientist assists the Clinical Science Head / Global Development Head in all areas of project/ study planning and works in cross-functional Clinical Team(s) to move new potential therapies from preclinical to early clinical development.


 


We are expanding. As an addition to our skilled project teams we are looking for a creative and collaborative colleague to support a dynamic and growing clinical development organization. In this role you will work together with experienced colleagues across Research and Development in the screening and functional characterization of our therapeutic DARPin molecules.


This challenging and diverse position will include the following tasks and responsibilities:



  • Provide technical and operational leadership and work in cross-functional teams to move new assets from preclinical to early clinical development;

  • Responsible for one or more clinical studies;

  • Responsible for developing study protocols, study conduct, maintenance and study read out;

  • Participate in the design/ execution of the clinical development strategy and plan and ensure GCP and SOPs are followed;

  • Develops medical and scientific aspects of study protocols, informed consent forms and other relevant clinical documents (SAPs, IDMC, SMC, SSC, DERC Charters), including study reports (CSR);

  • Possibility to present at Investigator meetings, Steering Committee Meetings, teleconferences and training meetings
    Act as a liaison between external partners (CRO, investigators and/or experts);

  • Interface with project team members including: Clinical Operations, Data Management, Statistics, Pharmacovigilance, Medical Writing and Project Management;

  • Work closely with Clinical Operations to ensure adequate executions of medical aspects of the study;

  • Lead or assist with Competent Authority and Ethics Committee/IRB submissions  (e.g. INDs, CTAs);

  • Responsible for the clinical aspects of the Data Review Plan;

  • Lead and participate ongoing monitoring of clinical activities and study conduct, coordination of data collection, data review, analysis and interpretation;

  • Identify trends/problems/ issues that could affect the results or completion of the study;

  • Preparation and presentation of results for informed decision-making;

  • Conducts literature reviews and prepare summaries to support clinical development programs;

  • Provide training and science input to operation colleagues and study site staff.


Requirements


For this position, we are looking for a highly motivated individual bringing along:



  • Undergraduate degree required, advanced clinical/science degree preferred (e.g. MD, PharmD, PhD) or equivalent relevant experience;

  • Must have experience in the pharmaceutical industry and working in clinical science/ research (5+ years);

  • Prior experience with clinical trials in Oncology/ Hematology/ Immunology;

  • Working knowledge of Phase I – II drug development
    Knowledge of medical aspects of GCP / ICH, FDA, EMEA and other relevant guidelines and regulations;

  • Experience in medical writing e.g.  authoring or co-authoring documents such as study protocol, SoC, ICF, CSR, SAP, IB, patient narrative, various charters, study results and developing/ applying organizational SOPs;

  • Proven ability in problem solving, focus on the solution
    Experience in performing review of clinical trial data in order to identify trends in safety or efficacy data;

  • Experience in outsourced CRO models and KOL communication;

  • Strong team player with good communication skills to work in a team matrix environment as leader and key contributor;

  • Ability to acquire knowledge and technical information;

  • Highly motivated and energetic with a can-do attitude;

  • Quality and detailed-oriented;

  • Excellent written and oral English skills.


Our offer


Partnership and collaboration are at the core of our company, our research activities and our product candidates. Molecular Partners offers an international working environment and the opportunity to collaborate with outstanding individuals from numerous disciplines, who contribute to our shared goals of scientific excellence, respectful teamwork and personal aspiration.


We foster true innovation and creative thinking to advance our therapeutic product candidates and continue to be inspired by the difference we can make for our patients.


At Molecular Partners you will discover a challenging job, inspiring colleagues and a true purpose. If you are interested in working at Molecular Partners, we are looking forward to hearing from you! Please submit your detailed curriculum vitae via our career portal.


Position localisation


Job location


Switzerland, Zürich, Schlieren


Preferred head hunter clause


 


We only accept online applications.


Please note Molecular Partners AG operates a list of preferred recruitment partners. For those partners who have no valid, signed agreement in place with Molecular Partners AG, all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Molecular Partners AG (including any of its subsidiaries, affiliates or related companies) are not subject to payment of any form of introduction, placement or referral fees.


Molecular Partners AG, Wagistrasse 14, CH-8952 Zurich-Schlieren, Switzerland.


www.molecularpartners.com

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