Medical Director, Clinical Development - Hematology/Oncology

Gilead Sciences, Inc.; Greater London; On-site; GBP 120,000 - 160,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Medical Director of Hematology/Oncology to oversee medical monitoring for clinical trials, guide study teams, and ensure compliance with regulatory guidelines. The ideal candidate will hold an MD/DO degree, have board certification in Hematology or Oncology, and possess extensive experience in clinical trial management and drug development. This position requires strategic leadership skills and collaboration with various stakeholders.

Qualifications

• Clinical development experience in the pharmaceutical industry.
• Specialization in Hematology or Oncology.
• Experience with CAR-T and multiple myeloma.
• Proven ability to design and implement clinical trials.

Responsibilities

• Provide medical monitoring to multiple clinical trials.
• Lead project/study teams for clinical studies.
• Conduct investigator meetings and site initiation visits.
• Ensure compliance with regulatory and ethical guidelines.

Skills

Clinical development experience

Experience managing oncology trials

Strategic leadership

Excellent initiative

Problem-solving skills

Education

MD/DO degree

Board certification in Hematology or Oncology

Job description

Job Description

The Medical Director of Hematology/Oncology provides medical monitoring to multiple clinical trials. Additionally, the Medical Director guides the project teams to design and implement clinical studies at high quality and in a time and cost-effective manner in line with the department and corporate goals and within regulatory and resource guidelines.

Responsibilities

• Provide medical monitoring to multiple hematology/oncology clinical trials
• Lead project/study teams to 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
• Implement 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
• Work with internal regulatory affairs team and other ethical guidelines relevant to the pharmaceutical industry, and ensure compliance with these external guidelines
• Work with internal pre-clinical scientists, translational scientists, business and commercial organizations in a cross functional manner
• Work in a cross-functional team environment, including with clinical operations, biomarker specialists, CROs, and regulatory affairs
• Provide clinical expertise and input for regulatory filings (i.e., BLA, MAA) as well as response to questions from regulatory authorities in the context of IND submissions, clinical trial applications or filing procedures
• Provide clinical guidance 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)

Requirements

• MD/DO degree and clinical development experience in the pharmaceutical industry.
• Board certification/specialization in Hematology or Oncology and experience managing oncology trials.
• CAR-T therapeutic area experience (preferred)
• Multiple myeloma disease area expertise (required)
• Phase 2 or 3 study experience within the pharmaceutical industry.
• Relevant drug development experience, either within industry or as a clinical investigator/physician scientist in academia, or equivalent experience.
• Demonstrated clinical development strategist with experience designing, implementing, and conducting clinical trials, with emphasis on late-stage clinical development.
• Knowledge of carrying out hematology/oncology clinical trials, including knowledge of hematology/oncology treatment options
• Strategic leadership and tactical skills, excellent initiative, and judgment
• 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 in a self-guided manner 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 dynamic small company environment with minimal direction and able to adjust workload based upon changing priorities
• May travel up to 25%
• Must be based in Stockley Park Gilead Office

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.