Senior Clinical Scientist, Late Stage Development

Development Munich, Germany


Description

Position at Seagen

Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us! 

 

Summary: 

Seagen’s Clinical Development organization is responsible for developing and executing the early (Phase I/first-in-human - Phase II) and late development (Phase II – IIIA) clinical strategies and plan to deliver medically-differentiated therapies that provide meaningful improvement to patients.  

The Clinical Scientist participates in development and execution of the Clinical Development (CD) strategy and programs and supports the assigned Medical Director(s) with various deliverables necessary for effective and efficient CD plan execution for the assigned molecule(s) and indication(s). 

In Late-Stage Development (LSD) Clinical Scientists have primary responsibilities for phase 2-3 including multi-country/multi-center trials. They support Medical Directors/Global Development Lead (GDL) with clinical documentation, representing CD on various sub-teams or other appropriate forums, supporting training of study site personnel, acting as a primary point-of-contact for questions and inquiries to CD regarding clinical studies, conducting ongoing medical safety data reviews, and providing clinical science inputs into study reporting. 

Clinical Scientists are expected to perform their responsibilities independently and will have regular external interactions with clinical study Investigators and team, -, external vendors supporting the work of CD, etc. They may also, alongside the Medical Director/GDL, participate in external interactions with health authorities (HAs). 

 

Principal Responsibilities: 

1. Cross-Functional Team Leadership & Management 
  • Participates in relevant (Late-Stage) functional Clinical Development Team(s) 
  • Represents LSD in sub-teams (e.g., Clinical Study Teams [CST]) relevant to assigned molecule(s)/indication(s), except the Global Development Team (GDT). As needed and appropriate, addresses LSD study or other program-specific questions, provides updates, delivers presentations, etc. May act as the lead LSD representative on sub-teams. 
  • As requested, or otherwise appropriate, trains new CST members on pipeline molecules and study May also, as appropriate, support relevant sub-teams in assigning and training new team members 
  • As appropriate, participates in ongoing enhancements/development of processes, structures, systems, tools, and other resources 
  • As appropriate, coaches and guides less experienced Clinical Scientists and/or supports on-boarding of new Clinical Scientists 
  • Where applicable, may manage one or more direct reports and is, in such instances, responsible for training, developing, and retaining talent of his/her staff. Consistently complies with all governing employment laws, regulations, and company HR policies & procedures 
2. Global Clinical Development Planning: 
  • Stays abreast of internal and external developments, trends, and other dynamics relevant to the work of LSD to maintain, always, a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease area(s) 
  • As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects 
  • Maintains scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment 
  • In collaboration with Medical Writing and other functions, takes an active role in the preparation of Clinical Study Protocol, amendments and related documents, Informed Consent Form, Study Operations Manual and Data Monitoring Plan, and other study crucial documents. 
  • Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists,, as well as multidisciplinary internal groups, including other groups in LSD/CD, research, Translational Sciences, Medical Affairs, Legal, etc. 
  • May participate in meetings, reviews, discussions, and other interactions regarding late development/ Phase II/III studies to provide clinical science input and guidance. Includes reviewing protocols and providing CD input into these 
  • Develop site and CRA training materials and present these at SIVs and IMs 
  • Expected to make important contributions to the CD strategy for the relevant therapeutic/disease area(s) within LSD 
  • Supports Medical Directors/GDLs by providing guidance and direction to CSTs and other relevant teams in developing components of the CD plan (e.g., analytics/data strategy, publications strategy, etc.)  
  • Where applicable and assigned, supports Medical Directors/GDL in providing other groups with information and input into budget/resource planning necessary to implement and execute the LSD program 
  • Supports Medical Directors/GDL in preparing for HA meetings. As appropriate, participates in HA meetings. Ethically, effectively, and professionally represents the interests of Seagen and patients 
3. Clinical Development Plan Implementation: 
  • Provides strategic clinical science support for assigned studies and programs: 
  • Leads or otherwise participates in ongoing CST and relevant sub-team meetings, other interactions, and communications 
  • Develops innovative clinical study designs for review and discussion with Medical Directors and/or GDLs 
  • Medical (LSD) resource for design and interpretation of clinical and preclinical programs to support existing and development candidates 
  • Conducts appropriate literature searches and reviews, prepares summaries to support CD programs 
  • Collaborates with clinical operations (Regional Clinical Trial Operations/RCTO), other groups and Medical Directors/GDLs to develop consistent language and criteria for the Informed Consent Form (ICF), protocol eligibility, protocol dose modification, protocol safety/tolerability and data monitoring, Case Report Forms (CRFs), CRF instructions, data analyses and outputs 
  • Collaborates with Medical Directors, clinical operations (RCTO), data management and other groups to conduct clinical review of study data, identifying and evaluating study data trends, outliers, protocol violators, etc. Evaluation of safety, pharmacology, and efficacy data from ongoing and completed studies 
  • Helps coordinate consistent use of language, criteria, and standards across multiple Seagen teams and projects 
  • Reviews and/or writes additional clinical science documentation and/or provides clinical science input into other documentation managed by other Seagen groups or functions (e.g., protocol summaries, safety monitoring plans, process documents, investigator brochures, etc.) 
  • Helps coordinate the successful completion of documents with other groups and functions 
  • As needed/appropriate, collaborates with others, especially Safety Evaluation and Risk management (SERM), in the review of safety narratives and other safety related guidelines and documentation 
  • Collaborates with clinical operations (RCTO) and Data Management (DM) to develop and implement the overall data quality plan 
  • Develops and provides input for clinical presentation slides and other materials for internal/external meetings and/or ongoing communications for review/discussion with Medical Directors/GDLs (e.g., investigator meetings, site initiation visits (SIV), study coordinator or clinical research administrator (CRA) training, study newsletters, communications to study sites, etc.) 
  • Collaborates with clinical operations (RCTO) to develop agendas, materials and other items for investigator and other relevant meetings pertaining to assigned studies and programs 
  • As needed/appropriate, accompanies clinical operations staff to study site visits, investigators, and other meetings 
  • Where assigned, acts as the primary LSD liaison/point-of-contact from the team for medical monitor inquiries from clinical operations (RCTO), clinical research organizations (CROs), etc. 
  • Responds to questions from other internal and external parties regarding assigned studies and programs 
  • Works with Medical Directors, clinical operations (RCTO), data management and potentially other groups to develop and communicate relevant medical inquiries 
  • Participates in ad hoc safety meetings (e.g., Study Safety Monitoring Committees) and tracks, analyses, and reports any potential safety events 
  • Reviews, analyzes and discusses clinical study reporting documents with Medical Directors and various other internal stakeholders. Submit clinical contributions to CSRs and clinical portions of regulatory documents 
  • Tracks items for inclusion in protocol/ICF amendments and works with other groups to ensure the timely and appropriate completion of protocol amendments 
  • Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management 
  • Assists Medical Director(s) in responding to HA inquiries 
  • Works closely with Medical Directors, clinical operations (RCTO) and other groups to close-out clinical studies, secure data, and complete study reporting 
  • Supports Medical Directors in preparing for internal/external meetings and presentations 
  • Participates in the development and implementation of communication strategies to support existing and completed studies. Includes KOL interactions, advisory boards, major medical meetings, congresses and other events, publications, and other materials  
  • May deliver key presentations, both internally and externally, to convey the LSD perspective and provide updates on strategies, plans and other activities. Includes presenting at advisory boards and other relevant external forums representing Seagen 
  • Writes and/or reviews abstracts, posters, content for scientific meetings, conferences, other events, and other publicly distributed materials and coordinates further reviews with internal partners and stakeholders. Coordinates submissions to scientific meetings and/or other appropriate venues or groups in collaboration with Scientific Communication 
  • Supports Medical Directors, regulatory and other internal stakeholders with completion and submission of regulatory filings and other regulatory documentation. Writes clinical science sections of HA meeting packages and assists in the development and review of other clinical documentation required for regulatory submissions and other regulatory processes 
  • Works with Medical Directors to drive ongoing data generation to address unmet medical needs and identify new or extended LSD studies or other programs for the relevant therapeutic area of assignment 
  • Completes and/or leads other special projects, as and when assigned, or otherwise requested 
  • Consistently complies with all governing laws, regulations, Seagen Standard Operating Procedures (SOPs) and other guidelines 

Qualifications: 

  • Clinical Development experience in Oncology and/or Hematology is preferred 
  • 2 or more years clinical trial/development experience (must demonstrate a minimum of 2 years clinical trial experience in pharma/biotech industry) 
  • 2 or more years of medical monitoring experience (must demonstrate a minimum of 2 years medical monitoring experience in clinical trial in pharma/biotech industry) 
  • Well-versed in all medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA and EMA, and other relevant guidelines, regulations, and principles 
  • Knowledge of drug development process, study design, clinical operations 
  • Demonstrates passion for helping patients with cancer and for science  
  • Experience working on a clinical team (or equivalent) 
  • Experience authoring aspects of a global clinical development plan or full clinical study protocol 
  • Extensive knowledge of clinical research, has successfully worked across Phase 2-3 development projects 
  • Broad experience in the principles and techniques of data analysis, interpretation, and clinical relevance including safety and efficacy data listing review experience 
  • Strong relevant therapeutic area experience (typically demonstrable with 4 or more years relevant experience) 
  • Understanding of product and safety profiles including principles of benefit-risk assessment 
  • Strong computer skills, including Microsoft Office Suite (Word, PowerPoint, and Excel) as well as Data Review Tools (RAVE/EDC, Spotfire, eCRF and query processes) 

ABILITIES AND ATTRIBUTES: 

  • Has impeccable ethics. Demonstrates, or proven abilities to demonstrate Seagen Values 
  • Used to work independently to perform Clinical Scientist responsibilities with no or minimum guidance and in a team environment, being flexible and adapting in a changing environment 
  • Collaborative style with internal company leadership, external development partners, and investigators/ medical professionals.  
  • In-depth knowledge of multidisciplinary functions involved in a company’s drug development process, e.g., clinical operations, biostatistics, regulatory, commercial operations, etc. and can proactively integrate multiple perspectives into the clinical development process for best end-results 
  • Excellent project management skills: can prioritize multiple tasks and goals to ensure the timely, on target and within-budget accomplishment of such 
  • Strong interpersonal, verbal communication and influencing skills: can influence without authority and has proven experience building and cultivating relationships with key partners and stakeholders, both internally and externally; be adept of managing relationships across collaborations and with the external clinical community 
  • Outstanding written communication skills 
  • Strong presentation skills: highly effective at summarizing and presenting the key considerations and decision-points 
  • Confident and competent when interacting with varying levels of internal/external management, KOLs, etc.: Stays focused and on-point, and able to raise problems or challenges in a productive, solution-oriented, and mature manner 
  • Strong negotiation skills: can effectively drive discussions and decisions toward desired end results 
  • Proven track record of effective decision-making makes good business decisions and exercises sound judgment. Consistently and effectively balances decisions with imperatives for ethics and efficacy 
  • Proven teamwork skills, has a proven track record of working highly effectively, efficiently and collaboratively with others, both as a leader and key contributor 
  • Has a global perspective and mindset, with demonstrated ability to work effectively with multidisciplinary teams and colleagues from myriad cultures, backgrounds, and geographies 
  • Ability to travel (<20%)  
  • thorough understanding of local compliance, as well as a sound ethical approach to business 

Education: 

  • Bachelor’s Degree required (life sciences preferred) 
  • Advanced Clinical/Science Degree is preferred (e.g., PharmD, PhD, MSN, MPH, or other scientific field preferred.) 

 

As a leading employer in our industry, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. To learn more about Seagen, please visit www.Seagen.com. 
 

Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment.   

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