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Senior Director, Clinical Scientist, Early Clinical Development

Employer
Regeneron Pharmaceuticals, Inc.
Location
Basking Ridge, New Jersey
Start date
May 25, 2022

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Job Details

The Senior Director, Early Clinical Development Experimental Sciences (ECDES), Clinical Scientist leads a group of Clinical Scientists that work alongside the Clinical Lead / Medical Directors at project stages both before and after the selection of a candidate for IND/CTA enabling activities).

While specialty knowledge will be valued and cultivated, this group will be considered early development and translational generalists capable of covering all Regeneron TFA/TAs in a disease-area agonistic way, with the exception of Oncology and hematologic malignancy programs.  Programs run from target nomination through clinical Proof of Concept. Clinical Scientist activities include supporting the Clinical Lead with literature review-based indication scoping, scientific gap analysis, design and execution of Clinical Experimental Studies, development of clinical plans and strategy presentations, study designs and development and authorship of clinical protocols involving Regeneron molecules, clinical study reports and regulatory documents.

The Clinical Scientists are responsible, alongside the Medical Director, for collaborating closely with the clinical study team on study choreography and execution, including interaction with study investigators and site staff and EC/IRBs, data safety monitoring boards, medical monitoring, assurance of data integrity and evaluation of study results and reporting (including senior level presentations).

The role holder will report to the Vice President, ECDES and is responsible for crafting a vision and setting standards for scientific and operational excellence, forming, building and developing a group of talented and committed Clinical Scientists, collectively delivering timely, scientifically rigorous and high-quality work to meet the needs of the Regeneron early pipeline and interacting successfully cross-functionally.  They are expected to operate skillfully in a highly matrixed environment, collaborating with ECDES leadership, ensuring projects are distributed in an equitable way that considers the priorities across the pipeline as well as the capabilities and development needs of the individuals. They will also have to navigate the balance of ensuring projects are delivered at the highest level while allowing scientific mentorship and supervision to emanate primarily from the project clinical leads/study physician.   They will also play a leading role in collaborating with key stakeholders to optimize relevant processes and improve role clarity around the clinical scientist role.

The role holder will also be taking on their own projects (“player-coach” model), modeling best practices with light supervision.

A day in the life may include the following:

  • Functional leader and people manager for the Clinical Scientist group within ECDES. Hires, develops and retains Clinical Scientist talent for ECDES. Coaches, mentors, trains and leads Clinical Scientists across ECDES. Identifies key experienced reports and works with them to develop a reciprocal peer mentoring culture for experienced and newer Group members alike. Extends coaching and training platforms into the ECDES Medical Director function, elevating the capabilities of Clinical Leads in project planning and execution.
  • Understand the Regeneron early pipeline (outside Oncology) and resulting resourcing needs; work with ECD&ES leadership and Medical Director people managers in ECDES to ensure aligned provision of Clinical Scientists along with Clinical Lead capabilities across all projects.
  • Understand and seek to optimize processes and procedures across asset teams/programs within ECDES. Works with key stakeholders outside ECDES (e.g. Data Management, Clinical Operations - including GCP Quality, Process Improvement, Human Resources) and inside ECDES (Medical Directors, Precision Medicine Leads and Operations, Clinical Imaging) to build visibility, clarify responsibility and optimize function of the Clinical Scientist/Study Director role. Drive consistent best practice and innovation.  Identifies and drives opportunities to initiate operational changes; operates with a continuous improvement mindset. 
  • Be the key functional point-of-contact or representative for the ECDES Clinical Scientist Group when reviewing processes and sharing best practices across all of the TAs in Global Development.
  • Lead and represent Clinical Science function internally and externally for ECDES, be a strong contributing member of the ECDES Leadership Team.
  • As a SME Clinical Scientist, model best practice for the group, by being a project level contributor. As such, accountable to the Clinical Lead for indication scoping and clinical strategic development; to the Clinical Study Team for activities such as first-line medical monitoring, raising and responding to investigator queries, writing safety narratives, analysis of trends of safety and efficacy and playing an essential role in regulatory submissions and response documents.

This role may be for you if you have the following experience/ qualifications:

  • Models the Regeneron way in the way they practice science and collaborate and lead with team members.   Is an excellent communicator. 
  • Expert knowledge of the global drug development process, good clinical practice, complex study design, and complex research methodology.  Is equally comfortable in working and leading people that support early stage scientific FIH teams as well as later stage PoC programs.
  • Can supervise, manage, mentor and coach formally within function (at a range of levels) and informally across functions
  • Can translate resource gaps into hiring needs, triage resumes and design and participate in interview panels.
  • Writes extremely well and can rapidly review and contribute to study related documents such as: medical monitoring plans, statistical analysis plans, data management plan, eCRF completion guidelines, data validation manuals, database UAT.
  • Trains and support study team and CRO personnel regarding clinical aspects of trial
  • Maintains and develops relationship with key study investigators, organizes steering committees, advisory boards, and data safety monitoring boards as required
  • Identifies program, trial or data risks, creates and implements mitigation strategies
  • Ensures Clinical Team compliance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety.
  • Can report effectively to supervisor and management on clinical trial findings and milestones

Education

  • Bachelor’s degree (Ph.D preferred) in Life Sciences, or PharmD, M.S., R.N.

Experience

  • 10-12 total years of combined academic and industry scientific experience, with at least 6 years of industry clinical research/development experience
  • Experience in leadership/mentoring/hiring preferred.
  • Experience of effective communications (verbal & written) and presentation skills are essential. 
  • Experience of working productively in a fast-paced collaborative environment.
  • Demonstrated application of critical thinking skills and sound decision-making.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Company info
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States

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