Director, Clinical Development, Oncology
Our client is a global biopharmaceutical company. They have asked us to assist them in their search for a Director, Clinical Development, Oncology
Major tasks and responsibilities will include:
We seek candidates with the following qualifications:
- Supervises trials, which can be key for submission, of higher complexity in design and geographic reach.
- Prepares clinical section of regulatory documents.
- Oversees management and performance of CRO.
- Participates in creation of developmental and regulatory strategy.
- Drafts protocol profiles and sections of key submission documents.
- Functions as point of contact with regulatory-agency clinical reviewing divisions.
- Acts as Clinical Development in Project Teams.
- Reviews patient population and protocol compliance for consistency with study strategy.
- Develops biomarker strategy in collaboration with others.
- Prepares and participate in regulatory agency meetings, if applicable.
- Contributes on major markers of trial, clinical trial and contingency planning.
- Analyzes and updates management on potential risks to study deliverables.
- Establishes and implements contingency plans for shortfalls.
- Outlines responses to IRBs and HA and works with TMCP to ensure appropriate measurements.
- Reviews emerging clinical data regularly.
- Leads dose-escalation meetings.
- Performs quality assessment with delivery lead and quality check of data.
- Holds responsibility for the valid clinical interpretation of study results.
- Advises on study plan, design and conduct to external advisory panels.
- Interacts, collaborates with and prepares materials for KOLs.
- Formulates early development plan and adds to overall development strategy.
- Develops program biomarker strategy.
- Achieves support for plan by function and team.
- Interprets and reacts accordingly to new data relating to the trial.
- Creates and Executes development strategy for a program.
- Hires and retain high quality (Team) members.
- Ensures team members have updated development plans and provide them with necessary means to achieve their personal development goals and reviews annual goals with them.
- Prepares annual performance reviews for direct reports and provide them with feedback.
- Outer participation in Business Development activities for late stage compounds.
- Participates with in-licensing and acquisitions on individual due diligence activities.
- Contributes to portfolio decisions.
- PharmD, PhD or equivalent is required with postgraduate training in TA or related area.
- MD is acceptable and highly desirable.
- Must have relevant clinical experience.
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.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.