Senior Director, Clinical Development, Oncology
Our client is a global biopharmaceutical company. They have asked us to assist them in their search for a Senior Director, Clinical Development, Oncology
Major tasks and responsibilities will include:
- Establishes and executes clinical drug development strategy.
- Delivers non-clinical package essential to support translation into clinical program by conferring with scientists.
- Designs and has oversight of multinational clinical trials, as well as provides Medical input and monitoring for active trials.
- Unites appropriate assays and strategies by working with Translational teams.
- Works with team on clinical protocols and investigator’s brochure, and outlines clinical development tactics and protocol profiles.
- Participates in creation of developmental and regulatory strategy in collaboration with Regulatory Affairs.
- Functions as the point of contact for communications with regulatory-agency clinical reviewing sectors on clinical matters.
- Oversees management and performance of CRO.
- Aids Marketing, in growing a commercial strategy including biomarker strategy.
- Supports Business Development and Licensing for assessment of new assets.
We seek candidates with the following qualifications:
- Works with cross-functional group to develop a thorough clinical strategy for program.
- Heads development of protocol answering key clinical and scientific questions.
- Works closely with cross-functional team members on protocols.
- Develops biomarker strategy in partnership with Translational Science.
- Works with KOLs to perfect study plans and outlines study strategy across clinical trials.
- Examines patient population and protocol compliance for uniformity with study strategy.
- Develops prospective contingency plans for management of key risks in a large study or project.
- Clearly defines study priorities and high level execution plan.
- Communicates ensuring clear and efficient lines of communication and decision-making process.
- Facilitates team coordination.
- Prepares responses to IRBs and HA.
- Works in partnership with QCP and Translational Science.
- Reviews emerging clinical data regularly.
- Leads dose-escalation meetings.
- Performs quality assessment with delivery lead.
- Works with Data Management to ensure SAP updates.
- Understands study results in the framework of other studies in the project and other drugs used for the indication.
- Evaluates, edits, approves and updates medical monitoring plan for large studies.
- Defines medical monitoring oversight component.
- Sets up DSMB and/or adjudication committee (as needed).
- Oversees CRO medical monitor events for a sizeable study and/or across a program.
- Guarantees monitoring/reporting of AEs/SAEs by working with CSPV.
- Reviews safety reports/data during study conduct.
- Assesses data before DBL from medical perspective, supports BDO in creation of TFG.
- Reviews, oversees creation of patient narratives.
- Affords medical direction to MW for the CSR.
- Details ongoing MM review of data for safety and quality at project level.
- Develops and leads steering committee for key trials.
- Leads Clinical Study Team (CST).
- Creates and executes development strategies for program/s before senior management.
- Obtains cross-functional alignment.
- Leads development and execution of Product Development Plan and clinical development strategy.
- Guarantees cross-functional coordination and focus to decided strategy by working directly with Global Project Management.
- Coordinates clinical activities across the project.
- Collaborates with team to propel peer-reviewed publications and external presentations related to program.
- Heads large study or project teams including multiple roles and many members.
- Provides input on KOL selection for Therapeutic Area.
- Reviews content to be shared with KOLs.
- Has regular involvement in Business Development activities.
- Participates with in-licensing and acquisitions on due diligence activities.
- Contributes to portfolio decisions in a major way.
- MD is highly preferred.
- PharmD, PhD or equivalent with exceptional qualifications is acceptable.
- Must have Postgraduate training in Oncology or Hematology, or significant past in field.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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