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Director Clinical Development - Oncology

2-4 years
Not Disclosed
10 Nov. 30, 2024
Job Description
Job Type: Full Time Education: MD/DO/PhD/PharmD/DVM Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Director, Clinical Development - Oncology

Location: Parsippany, NJ, USA (Hybrid work model with West Chester, PA option)
Company: Teva Pharmaceuticals
Job ID: 58170
Date: November 10, 2024


Who We Are

Teva Pharmaceuticals is dedicated to improving health worldwide by making medicines more affordable and accessible. Operating in nearly 60 countries, we are a leader in generic and innovative medicines. At least 200 million people take our products daily, underscoring the significant global impact of our work.


The Opportunity

As the Director of Clinical Development - Oncology, you will manage clinical programs across all phases of research, driving strategy, execution, and oversight. You will lead cross-functional teams, ensuring clinical projects meet regulatory and operational standards. This role requires a combination of strong clinical expertise, oncology experience, and leadership capabilities.

You will also be a key player in global initiatives, supporting INDs, NDAs, and BLAs, and collaborating across departments like regulatory, commercial, pharmacovigilance, and manufacturing.


Key Responsibilities

  • Leadership and Strategy:

    • Develop and manage Clinical Development Plans for oncology programs.

    • Lead cross-functional clinical teams and contribute to Global Project Teams.

    • Ensure trials adhere to clinical guidelines, ICH, GCP, and country-specific regulations.

    • Drive clinical strategy and execution for regulatory submissions (INDs, NDAs, BLAs).

  • Operational Management:

    • Oversee clinical study design, implementation, and completion, ensuring timelines and objectives are met.

    • Collaborate with the Clinical Supplies Group to manage drug supply planning and logistics.

    • Resolve clinical and safety issues in partnership with Drug Safety and Pharmacovigilance teams.

    • Lead or contribute to NDA submission teams as needed.

  • Collaboration and Communication:

    • Work cross-functionally with Regulatory Affairs, Biostatistics, CMC/Formulations, Legal, and Marketing teams.

    • Represent Teva at scientific meetings, advisory boards, and regulatory agency discussions.

    • Foster relationships with Key Opinion Leaders (KOLs) in oncology.

  • Documentation and Reporting:

    • Prepare and review protocols, Investigator Brochures, and Clinical Study Reports.

    • Author or review abstracts, posters, and manuscripts for scientific dissemination.

    • Analyze clinical results and guide high-quality reporting with the Medical Writing team.


Qualifications

  • Education:

    • MD, DO, or equivalent. Advanced degrees (PhD, PharmD, DVM) with proven track records may be considered.

  • Experience:

    • Minimum 3 years in clinical trial management in the pharmaceutical industry.

    • Prior oncology experience is strongly preferred.

    • Experience managing projects in a global matrix organization.

    • Managerial experience (2-4 years) preferred.

  • Skills:

    • Strong verbal and written communication skills.

    • Ability to manage multiple priorities and thrive in a fast-paced environment.

    • Proficient in clinical data analysis and interpretation.


Travel

Approximately 30% travel, domestic and international.


What We Offer

  • Comprehensive Benefits Package:

    • Medical, Dental, Vision, and Prescription coverage from Day 1.

    • Disability and Life Insurance.

    • 401(k) with 6% company match.

    • Employee Stock Purchase Plan.

  • Work-Life Balance:

    • Paid Time Off, including 13 holidays.

    • Tuition Assistance Program.


Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to diversity and inclusivity. We provide equal opportunities regardless of age, race, religion, gender identity, disability, or veteran status. If you require accommodations during the hiring process, please let us know, and your information will be treated confidentially.


Important Notes for Employment Agencies

Teva does not accept unsolicited CVs or resumes from agencies without a prior written agreement for the specific role.

Join Teva and contribute to transformative oncology advancements!