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Sr Director, Clinical Research

Foster City, CA, USA | Leading Pharmaceutical / Biotech Company

  • Industry:
    Pharmaceutical / Biotech
  • Position Type:
    Full-Time
  • Functions:
    General Management
    Biotech/R&D/Science
  • Experience:
    5-7 years
Job Description:
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Job Description

The Senior Medical Director, Clinical Development provides clinical leadership and input to the Vice President, Clinical Development on clinical studies, program strategies and life cycle management. He/she provides Clinical study and launch support and works closely with cross-functional groups that include Research, Translational Sciences, Clinical Operations, Regulatory, Patient Safety, Medical Affairs, and Commercial to ensure that Clinical Development scientific and medical strategies are aligned with broader corporate and patient needs. He/she is expected to have a strong commitment to achieving corporate objectives while maintaining the highest ethical, regulatory and scientific standards.


Responsibilities include, but are not limited to:


Lead project teams to strategically design and implement hematology/oncology clinical studies

Write protocols, investigator brochures, clinical study reports and review clinical trial documents

Conduct investigator meetings and lead site initiation visits with clinical trial investigators

Execute and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets

Translate findings from research and nonclinical studies into clinical development opportunities

Interact with clinical investigators and thought leaders

Provide clinical leadership and work in a team environment in interactions with external stakeholders (medical experts, advisory boards, patient advocacy groups) and internal stakeholders (Research, Translational Sciences, Clinical Operations, Safety, Regulatory, Medical Affairs, and Commercial)

Provide strategic support and work closely with Medical Science Liaisons (MSLs), participation and insight in MSL activities, such as KOL interactions

Provide medical support as needed on company and non-company sponsored studies, non-interventional studies and investigator sponsored studies

Perform other duties as required

Requirements:


M.D. degree is an absolute requirement with board certification/specialization in Hematology or Oncology and experience managing oncology trials

At least 5 years of relevant drug development experience, either within industry or as a clinical investigator/physician scientist in academia, or equivalent experience

Proven clinical development strategist with experience designing, implementing and conducting clinical trials, with emphasis on proof-of-concept and first-in-human studies

Knowledge of carrying outhematology/oncology clinical trials, including knowledge of hematology/oncology treatment options

Strategic leadership and tactical skills, excellent initiative and judgment, and demonstrated ability to positively represent the goals of Kite

Demonstrated ability to develop and maintain excellent working relationships with both internal colleagues and external contacts, including key thought leaders, and investigators

Demonstrated ability to work well in teams in a cross functional manner

Ability to communicate and work independently with scientific/technical personnel

Ability to think critically, and demonstrated troubleshooting and problem solving skills

Self-motivated and willing to accept temporary responsibilities outside of initial job description

Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based upon changing priorities

Excellent written and oral communication skills, including presentation skills

Possess an understanding of applicable US and EU drug development regulations and GCP regulations

May travel up to 20%


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