Senior Clinical Development Director Oncology ( Early Development)

Posted 11 months ago

Key responsibilities:

Clinical development strategy

  • Provides the strategic direction and clinical development plans (definition and updates).
  • Is a permanent member of Core team, leader of the clinical sub-team and depending on the program, may also be a member of study team.
  • Provide medical/clinical expertise to Core Team to support the development and Launch of the product.
  • Assist the Program Leader for drawing up the project strategy, including the search of new indications.
  • Is responsible for clinical input in both internal and regulatory project documents
  • Contribute to the review of available data and competitive environment for the product(s). Maintain up to date awareness of all-important advances within a given disease area through scientific literature, attendance at critical meetings and relationships with Key Opinion Leaders (KOLs).
  • Establish and maintain communications with prominent clinical investigators in field of expertise. Liaise with internal and external medical community to follow developments within area of expertise.
  • Set-up and manage Advisory Boards.
  • Frequent involvement in Business Development activities.
  • Represent the company clinical perspective in meetings with partners. Involvement on due diligence activities.
  • Contributor to portfolio decisions.

Develop clinical trial protocol

  • Develop a well thought, and medically solid clinical trial synopsis aligned with the clinical development strategy.
  • Develops medical content for protocol and amendments.
  • Support clinical operations team to the selection of investigators/sites to run clinical trials.
  • Support regulatory team for successful submission of protocol to regulatory authorities.

Medical monitoring of clinical trials

  • Serve as a trial level physician and medical monitor for clinical studies.
  • Leads dose-escalation meetings.
  • Reviews emerging clinical data regularly.
  • Managing and oversee the medical monitoring teams of CROs.
  • Provide consultation to clinical operation colleagues on protocol design questions and answering protocol related questions from site investigators.
  • Work in close collaboration with the pharmacovigilance team to ensure adequate overview of the safety signals in the ongoing trials.
  • Interpretation of clinical trials results and contribute to clinical development strategy
  • Work in close collaboration with the data management and statistics team to ensure proper analysis of clinical trial results.
  • Writing of medical section in investigator brochure and other regulatory documents.
  • Contributing to writing clinical study report.
  • Contributing to publications, data presentation at scientific meetings, and manuscript writing.

Your profile:

Essential:

  • Graduate of a recognized school of medicine with an M.D. degree or equivalent with more than 5 years’ experience pharma experience (including in big pharma) this time spent should not include consulting or academia and consulting or academia should not be most recent job.
  • Board Certification, Eligibility, or fellowship training in Oncology is required.
  • Must have experience in clinical strategy in developing molecules from with experience in early phase clinical studies especially with monoclonal antibodies.
  • Demonstrated experience in clinical report writing and publishing.
  • Established understanding of pharmacokinetic and pharmacodynamic activities, including biomarkers and pre-clinical studies.
  • Should have a strong scientific understanding and the importance in clinical studies.

Desirable:

  • Specialty training in Immuno-Oncology, Tumor Immunology, or Immunotherapy.

Competencies, Skills and Behaviors

Technical Competencies

Essential:

  • Experience in medical monitoring of phase I/II clinical studies in industry, CRO or academic setting.
  • Experience in protocol writing and preparation of submission to regulatory authorities.
  • Experience in trial data analysis, interpretation, reporting and presentation (oral presentation, posters, publications).
  • The applicant must be able to read, write and speak English.

Desirable:

  • Experience in communication with FDA/EMA (e.g. cooperation on an industry sponsored phase 3 trial).
  • Previous participation or coordination of advisory boards.
  • Training in statistics or clinical trial methodology.

Additional Skills/ Behaviors

  • Highly motivated, dynamic physicians with aspiration to evolve and develop in the clinical development space.
  • Strong interpersonal, presentation, and excellent written and verbal communication skills.
  • Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
  • Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
  • Develops technical and/or business solutions to complex problems.
  • Demonstrated ability in decision-making, influencing, leadership, and affecting change by using a collaborative approach.
  • Results orientated work ethic and a positive, can-do attitude.
  • Strong organizational and time management skills.
  • Leads or manages the work of others by providing guidance to subordinates based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.
  • Works on complex problems where analysis of situations or data requires an in[1]depth evaluation of various factors.
  • Works on abstract problems across functional areas of the business.
  • Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.
  • Comfortable challenging the status quo and bringing forward innovative solutions.
  • Ability to build strong partnerships and drive role clarity across cross-functional teams as well as with external organizations.
  • Highly motivated, self-driven and dependable.
  • Willing and able to be “hands on” and willing to “roll-up sleeves” and delve into details as needed.
  • Ensures budgets and schedules meet corporate requirements.
  • Creates formal networks involving coordination among groups. Regularly interacts with executives and/or major customers.

Job Features

Job CategoryCLINICAL DEVELOPMENT

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