Job description

Associate Director Clinical Scientist

Rockville, Maryland, United States

ASSOCIATE DIRECTOR, CLINICAL SCIENTIST

Join a pioneering biotech with a collegial atmosphere and a passion for harnessing every individual’s unique set of skills in our fight against disease.

At Immunocore, we have a vision to transform the way we understand and treat the most challenging medical conditions of our time, including cancer, autoimmune disorders and infection. In January 2022, in the U.S., we launched the world’s first T-cell receptor therapy, built on a novel technology designed to overcome the limitations of our natural immune systems.

Joining us at the most exciting time in our history, you will be part of a team that values trust and innovation, and that cherishes different ways of thinking.

The Role:

  • Execute clinical development activities including analysis, interpretation, and presentation of data for one or more assigned studies.
  • Provide clinical development expertise and input to clinical study team and ad-hoc support for program team.
  • Contribute to development of the clinical strategy.
  • Mentor junior clinical development scientists.

Responsibilities:

  • Ensure adherence to pertinent regulatory requirements (eg, ICH GCP) and Immunocore policies, practices, and procedures.
  • Collaborate with Regulatory and Compliance to foster a compliant, high-quality, and inspection ready culture, adapt to changes in regulatory requirements, and improve SOPs and work instructions.
  • Perform routine data reviews (including safety, efficacy, and biomarkers), write queries, and escalate issues in collaboration with Data Management and Clinical Operations.
  • Analyse and interpret safety, efficacy, and PK/PD data and identify trends and signals in collaboration with Biometrics, Translational Medicine, and Pharmacovigilance teams.
  • Present study results to study team, Investigators, and governance bodies.
  • Draft content for abstracts, presentations, and posters.
  • Lead authoring of selected clinical documents (eg, Protocol, Investigator’s Brochure, Informed Consent) and participate in review of all key study documents.
  • Provide clinical input on training slides, study plans / manuals, and CRF design.
  • Support site selection, activation, and engagement activities including outreach to Investigators and performing trainings at site initiation visits.
  • Foster cross-functional collaboration and develop potential solutions to study issues that may impact budget, resources, and/or timelines.
  • Provide expert, collegial support and leadership to achieve study and program objectives.
  • Identify opportunities and lead process development initiatives.
  • Establish best practices and ensure a consistent approach across studies and teams.

Qualifications: 

Essential

  • Understand and apply the principles of GCP.
  • Deep understanding and extensive experience in the processes and strategy of drug development, with a focus on first-in-human / early-stage oncology.
  • Excellent data analysis, data visualization, and communication skills, with proven ability to write clear, accurate, and concise documents, construct informative figures, and present to diverse audiences.
  • Experience contributing to core study documents.
  • Able to safeguard patient safety in clinical studies, including identifying trends in AE and lab data, reviewing SAEs and AESIs, developing risk mitigation strategies, and understanding when to escalate to the Medical Monitor.
  • Self-motivated; demonstrated success in delivering assigned tasks according to timelines.
  • Demonstrated history of creative problem-solving and learning agility.
  • Effective collaboration with as well as ability to impact and influence cross-functional teams and, in selected situations, senior leaders.
  • PhD, PharmD, RN, or MD; relevant BS or MS with extensive professional experience.
  • 5+ years of pharmaceutical industry experience with at least 1-2 years of clinical development experience.
  • Periodic travel (~15-20%) to participating study sites as well as between Immunocore US sites will be required (includes overnight and international travel).
  • Attendance of leading industry meetings as required.

Desirable

  • Strong publication and presentation record.
  • Experience supporting interactions with global health authorities.
  • Background in immunology and experience developing immunotherapeutics.
  • Experience working with CROs including providing oversight.
  • Experience incorporating, implementing, and evaluating translational endpoints.
  • Experience integrating complex clinical and translational data to support dose selection.

Lead with Science and Discover What is Within:

  • We value Entrepreneurship and Diversity
  • Respect, Trust, and Integrity
  • Competitive compensation
  • Medical benefits, beginning your first day of employment
  • Vision benefits
  • Fully paid Dental Insurance
  • 20 days’ vacation plus holidays
  • Fully paid Life Insurance and Disability
  • 401(k) with Company Match

Candidates must be eligible to work in the U.S. without company sponsorship, now or in the future, for employment-based work authorization. F-1 visa holders with Optional Practical Training (OPT) who will require H-1B status, TNs or current H-1B visa holders will not be considered. H1-B and green card sponsorship is not available for this position.

Immunocore is an E-Verify employer.  

Applicants have rights under Federal Employment Laws:

Family and Medical Leave Act

Equal Employment Opportunity Commission

Employee Polygraph Protection Act

Uniformed Services Employment and Reemployment Rights Act (USERRA)

Right to work

EEO is the Law Supplement

Pay Transparency

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