Mallinckrodt

Mallinckrodt

Senior Director, Clinical Development

US Specialty Brand Headquarters - USA501, United States of America · Director

Sponsorship not specified$285k-$315kDetected 10 hours ago
GCPData AnalysisStatisticsProject ManagementClinical TrialsClinical ResearchScientific WritingResearchExperimental DesignLeadershipCommunicationCollaborationPublic SpeakingWritingMicrosoft Office

About the role

  • They will be responsible for oversight and management of the clinical development execution aspects of clinical development programs.
  • They are ultimately accountable for the on-time achievement of study and/or program milestones in alignment with the program team strategic imperatives.

Responsibilities

  • This purpose drives us as we pair quality therapeutics with human support-showing up in big moments and small to help patients find comfort and confidence.

Requirements

  • Minimum of 8-10 years of Clinical Development experience (pharma, CRO) in Immunology/Autoimmunity
  • Demonstrates ability to analyze and interpret data, assess clinical relevance and present/report findings (e.g., ISS, ISE, competitor data, etc.).
  • Experience working on a matrix cross-functional clinical team.
  • proven negotiating track record.
  • Working knowledge of statistics, data analysis and data interpretation.
  • Experience with the operation aspects of clinical trials and related activities such as investigator meetings, DSMB's and GCP/ICH are necessary.
  • Management reserves the right to change or modify such duties as required.
  • Education & Experience
  • Board licensed MD (or equivalent foreign qualification) in Immunology
  • Previous experience designing and developing phase 1-4 protocols.
  • Therapeutic area experience preferred (demonstrable with 2 or more years relevant experience).
  • Previous project management/clinical operations experience desirable.
  • Knowledge
  • Demonstrated ability to manage multiple and diverse projects concurrently.
  • Demonstrated ability to develop relationships and generate collaborations.
  • Strong analytical skills
  • a strategic thinker, planner and implementer

Nice to have

  • Act as the key contributor in development of clinical development strategy across multiple indications.
  • Track with Program Management the CD deliverables across all clinical studies/projects.
  • Reviews the informed consent form (ICF)
  • ensures alignment with the related safety sections of the study protocol.
  • Helps to identify additional opportunities within the broad R&D portfolio
  • Ensure regular and ad-hoc data reviews and interpretation
  • preparation of summaries/documentations of these reviews to Leadership.
  • Ensure CD participation in vendor selection, specification development, and management/oversight, as needed.

Skills

  • Please note that base pay offered may vary depending on factors including job-related knowledge, skills, and experience.

Compensation

  • The expected base pay range for this position is $285K - $315K.

Benefits

  • This position is eligible for a bonus in accordance with the terms of the applicable program.
  • At Keenova, we believe that no one should be alone in their pursuit of better health.
  • We bring deep expertise and resolve to every therapeutic area we serve, including immunology, urology, men's health, orthopedics, critical care, and pediatric endocrinology.
  • We work with patients, care partners, and physicians to help them navigate healthcare system complexity and access therapies that make a meaningful difference.

Company info

  • Bonuses are awarded at the Company's discretion.
  • We are Keenova-keen to solve, keen to serve.
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This listing is sourced directly from Mallinckrodt's careers page and normalized into a canonical job model.