Company Overview

This is a pharmaceutical company that focuses on discovering and developing new therapeutic drugs for the treatment of cancer and other critical diseases.

Position Title: Senior Medical Director, Clinical Development Melanoma Studies - Job #2107-5602

Territory: Multiple

The Senior Medical Director is the primary medical lead for clinical trials with cross-functional study teams on clinical trial strategy, design, and execution. S/he also will serve as the primary Medical Monitor responsible for monitoring the safety of enrolled subjects on assigned trials. This role will specifically focus on strategy and development of the Melanoma program along with other solid tumor indications.

Essential Duties and Responsibilities

  • Participates in the development of Study Protocols, Investigator's Brochures, Clinical Development Plans, and other key study documents in conjunction with other line functions.
  • Serves on cross-functional teams for assigned trials, working with other team members to achieve efficient, high-quality study execution.
  • Participates in the preparation of regulatory documents in support of regulatory submissions, including clinical section of IND’s and CTA’s, IND safety reports, and annual reports for assigned trials, responses to regulatory authorities, and Ethics Committees/IRBs, and other documents as appropriate.
  • Provides scientific and clinical input to study-related documents and analysis plans, including informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology analysis plans (CPAP), and clinical study reports (CSR).
  • Acts as liaison between Clinical Development and other internal groups for assigned studies.
  • Develops and executes life-cycle management plan and lead data generation activities, such as Medical Affairs studies to unmet medical needs and data gaps.
  • Supports Medical Affairs: works with field medical, Scientific Communication and Publication, and Medical Information and Communication teams to provide support, including reactive material development to address external stakeholder questions.
  • Helps identify thought leaders and interacts with them to engage in scientific and medical exchange, as well as understands unmet medical needs and data gaps.
  • Supports IST Program.
  • Partners with pharmacovigilance to assess the safety profile of compounds.
  • Maintains a high level of clinical and scientific expertise in the disease area(s) by reviewing the literature, attending medical/scientific meetings, and through personal interchanges with consultants, thought leaders, investigators, and internal stakeholders.
  • Authors manuscripts and collaborates with cross-functional colleagues and thought leaders to meet publication plan objectives.
  • Maintains ethical standards of the highest level and has the knowledge and ability to comply with all relevant ethical, regulatory, and legal standards.
  • May participate in or lead clinical development contributions to due diligence or other business development activity.
  • As required, contributes to the design and implementation of translational strategies.
  • Leads clinical study teams.
  • Presents at scientific, medical, and regulatory meetings.
  • Develops and maintains relationships with academic investigators, pharmaceutical partners/sponsors, KOL’s, and patient advocacy groups
  • Contributes to activities in support of the company’s planned NDA submissions. Authors clinical sections for INDs, NDAs, and other related documents.

Qualifications (Education & Experience)

  • MD, DO or equivalent ex-US medical degree.
  • 1-2 years of experience developing strategy and execution of melanoma studies along with experience with other solid tumor indications.
  • 5-10 years clinical trial experience in an academic or industrial setting, with experience in the analysis of research data and publications; working knowledge of biostatistics and pharmacokinetics; working knowledge of GCP, scientific and clinical research methods and clinical study design, regulatory requirements for clinical studies.
  • At least 3 years experience as an attending physician in oncology, hematology, internal medicine, or relevant medical specialty area.
  • Cancer research experience.
  • Pharmaceutical/Biotech industry experience, including time managing clinical trials and/or clinical development program(s) mandatory.
  • Excellent oral and written communication skills.
  • Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate.

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