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Senior Clinical Scientist

Location London, United Kingdom
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives. 

SUMMARY DESCRIPTION

The Senior Clinical Scientist contributes to or leads tasks related to Clinical Science core deliverables across all stages of program and study design and execution, data analysis and regulatory filings as delegated by the Clinical Science Therapeutic area lead or other Clinical Science leader. This includes: developing key documents to support study execution; developing subject matter expertise on a specific therapeutic area or development program through literature review, leveraging relationships with external parties (KOLs, Investigators) and clinical trial data review and sharing insights with CLS teams; and conducting data analysis in support of reporting and message development.

KEY RESPONSIBILITIES:

As a vital member of the valoctocogene roxaparvovec (BMN 270) CLS team, the Senior Clinical Scientist partners with a Medical Director to uphold medical and scientific integrity during study planning and execution and participates in the day-to-day CLS medical monitoring deliverables. Key responsibilities, as delegated by head of the CLS Haemophilia Gene Therapy, or line manager may include:

Medical and Scientific Expertise

  • Assist in the development of key documents to support the components of trial execution and regulatory submission (including IND Annual Reports, Investigator Brochures, Briefing Books and Pediatric Plans)
  • Support the design, update and implementation of Clinical Development Plans (CDPs), and work with Project Management to ensure progress in line with current plans and timelines
  • Provide input to regulatory documents required for clinical studies and regulatory submissions
  • Develop scientific rationale for methods, design and implementation of clinical protocols, data collection systems and final reports
  • Stay up to date with advances in literature in therapeutic/disease area including mechanism of action, diagnostic tests, treatment, drug development trends, and regulatory requirements
  • Develop therapy-specific publication plans and work with internal and external colleagues to prepare study results for timely publication
  • Attend and contribute to relevant scientific conferences, seminars or presentations
  • Engage and establish rapport with KOLs and scientific or clinical experts
  • Contribute to content and submission of abstracts to key symposia
  • Work with CLS and Clinical Operations to ensure the success of Investigator Meetings by contributing and presenting scientific content

Data Analysis

  • Develop thorough understanding of clinical trial data to help guide the drafting of CSRs and Key Messages.
  • Perform preliminary analyses on clinical study data as it becomes available to help build and guide Statistical Analysis Plans (SAPs)
  • Help define study quality metrics and perform medical data reviews during study execution to ensure integrity of accruing study data

Clinical Science Communication and Collaboration

  • Serve as CLS representative and primary contact for the assigned clinical study on the Study Execution Team (SET), and liaise with Pharmacovigilance, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, Data Monitoring Committees (DMCs) and other internal or external entities as needed
  • Plan and organise visits or lectures from external experts and KOLs
  • Manage Steering Committee and investigator meetings; specifically, by setting dates, developing content, building presentations, disseminating information and documents, keeping minutes, and otherwise ensuring adherence to roles and responsibilities defined in the SC charter
  • Collaborate with Clinical Science leadership to maintain the CLS website with external meeting calendars, relevant milestones, and publications
  • Collaborate with Clinical Science leadership to create and/or review slides for internal and external meetings

COMPETENCIES

A Senior Clinical Scientist demonstrates foundational skills in communication and collaboration, proactivity, medical and scientific knowledge, drug development, data analysis, and scientific writing. S/he is developing skills in leadership, regulations and compliance, and external stakeholder engagement. The Sr. Clinical Scientist:

  • Responds promptly to stakeholders, peers and management with clear and organized messages and ensures that important information is shared in a timely manner
  • Appropriately escalates potential issues, clearly communicating whether the escalation is informational or requires action
  • Demonstrates basic knowledge of relevant therapeutic area, disease conditions and unmet medical needs
  • Understands key documents associated with key stages of clinical studies (start-up, conduct, close out)
  • Understands how study data flows from patient to reports across systems during the life of a study
  • Understands the basic structure and methods for scientific message

QUALITES/ABILITIES

  • Impeccable ethics
  • Outstanding attention to detail
  • Demonstrated, through past experience, ability to independently manage majority of CLS deliverables associated with assigned clinical studies
  • 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
  • Outstanding written communication skills
  • Strong business presentation skills: highly effective at summarizing and presenting 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 is able to raise problems or challenges in a productive and mature manner

EDUCATION AND EXPERIENCE

  • Bachelors degree in life or health sciences required
  • Advanced Clinical/Science degree preferred (e.g., PhD, PharmD, MSc, etc.)
  • 3 or more years of relevant clinical sciences/development experience in industry required; experience in gene therapy, hematology/hemophilia, and/or rare diseases preferred

WORK ENVIRONMENT / PHYSICAL DEMANDS / TRAVEL

Up to 30% travel may be required.

CONTACTS

Internal: Clinical Operations, Pharmacovigilance, Regulatory Affairs, Patient Advocacy, Biometrics, Development Sciences Quality (DSQ), Global Medical Affairs, Legal, Corporate Ethics & Compliance, Corporate Communications, Pipeline Commercialization, Business Operations
External: Key Opinion Leaders, Clinical Trial Site MDs and Staff, vendors and suppliers

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

About our location

London

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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