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Associate Director, Clinical Science

Location United States, Remote

Workstyle Open to Hybrid
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.

BioMarin Clinical Science (CLS) is responsible for overseeing clinical programs across various phases, from proof-of concept to Phase 3 and BLA filing. The Clinical Science team provides leadership for clinical strategy and oversight to ensure excellence in clinical trial conduct, data analysis and interpretation, publication preparation, and safety monitoring.

SUMMARY DESCRIPTION

The AD 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 Program Lead or other Clinical Science leader. This includes: clinical trial data review, conducting data analysis in support of reporting and message development both within the CLS team as well as externally, developing key documents to support study execution, developing subject matter expertise on a specific therapeutic area or development program through literature review, and developing and leveraging relationships with external parties (KOLs, Investigators).                      

KEY RESPONSIBILITIES:

Responsibilities may include, but are not limited to:

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
  • 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

  • Review data on an ongoing basis to ensure completeness and quality of clinical data sets
  • 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 inform on key questions
  • Help define study quality metrics and perform data reviews during study execution to ensure integrity of accruing study data

Clinical Science Communication and Collaboration

  • Serve as CLS representative 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 organize visits or lectures from external experts and KOLs
  • Contribute to Data Monitoring Committee (DMC) and investigator meetings; specifically by developing content, building presentations, disseminating information and documents, keeping minutes, and otherwise ensuring adherence to roles and responsibilities defined by DMC charter
  • Collaborate with Clinical Science leadership to create and/or review slides for internal and external meetings

COMPETENCIES

An  AD 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 AD:

  • 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 development

The AD will also develop relevant clinical and therapeutic area knowledge to support clinical decision making, problem solving, safety surveillance, as well as collaboration with external physician stakeholders.

CAREER DEVELOPMENT

BioMarin offers comprehensive career development programming, including guidance, targeted training opportunities, and mentorship programming. A career development pathway for Clinical Science has been defined and is available to employees of BioMarin.

EDUCATION AND EXPERIENCE

  • MD, MD/PhD (or equivalent)
  • minimum of a Bachelors degree in life or health sciences 2 or more years of relevant experience in genetic diseases, metabolic diseases, specialty care, and/or rare diseases desired; Clinical experience preferred

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


PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.

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

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