Job Description

Job Description

Job Description

Medical Director (Clinical Development) / Sr. Medical Director (Clinical Development)

Job Type: Full-time

Salary : $200K - $250K

$250K - $300K

Location: Palo Alto, CA (Hybrid - 2-3 days a week onsite)

*** Candidates local to Pacific NW and other areas in CA will be considered based on the discretion of the hiring team.***

Company Summary: Global biopharma company based in the SF Bay Area focusing in advancing the oncology space through antibody discovery and development. Their pipeline spans ADCs, bispecifics, and multispecific therapies that targets oncology, immunology, and neurodegenerative diseases. As they continue to grow, they hope to be at the forefront of next gen biologics innovation.

The Opportunity: Join as an experienced and driven MD to lead and support the clinical development of their Ph1-3 oncology pipeline. In addition, this person will be a key leader in study design, planning, execution and will contribute greatly to regulatory interactions.

Responsibilities:

• Clinical Development Strategy
• Provide strategic input into the design and execution clin dev plans and trials
• Contribute with geostrategy, site identification & selection, investigator engagement, and KOL/professional organization/advocacy group engagement
• Act as the clinical expert on product teams in line with overall program goals
• Trial Execution
• Provide medical oversight for ongoing clinical studies
• SME role in creation and revision of study protocols, investigator brochures, and other key documents
• Contribute to drafting and review of clinical study reports, abstracts/congress presentations, and manuscript submissions

• Cross Functional Collaboration
• Work with other functional teams to ensure timely and high quality trial conduct
• Partner with Regulatory Affairs to formulate regulatory strategy - prepare for and participate in regulatory interactions (e.g., FDA, EMA, PMDA), and produce high quality regulatory submissions.
• Collaborate with Safety/Pharmacovigilance to monitor and assess safety data, support DMCs, respond to safety-related issues, and prepare requisite safety updates (eg. DSUR).

Qualifications

• MD or MD/PhD required with Board Certification or Eligibility in oncology and/or hematology
• Minimum of 3 years of industry experience in oncology drug development
• Previous exp executing global oncology clin dev plans and familiarity with regulatory pathways & submissions
• Strong knowledge of GCP-ICH guidelines

Preferred

• Experience with novel therapeutic modalities (e.g., immuno-oncology, ADCs, cell therapy).
• Prior direct involvement in successful regulatory filings (e.g., IND, NDA, BLA).
• Familiarity with biomarker-driven drug development and translational medicine

Benefits:

• Competitive base salary, bonus, and equity for all employees.
• 401(k) retirement plan with employer matching contributions.
• Comprehensive medical, dental, and vision insurance.
• Generous paid time off policy, including company holidays and floating holidays.

A top 10 pharmaceutical company with an immense amount of growth after releasing their at home COVID diagnostic tests is looking to bring on 200+ Quality Individuals through a massive hiring campaign. In their search for Quality Specialists, the organization is looking for individuals who will be responsible for reviewing and actioning customer complaints, as well as investigation into said complaints.
Job Responsibilities:
•\tConducting Post Market Activities and Post Market Surveillance
•\tManaging Customer and Product Complaint Investigation programs
Education and Experience:
•\t1 YR. of experience in a technical role in the medical device/pharma/biotech industry
•\tBachelor's degree
•\tComputer proficiency

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