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Director Clinical Development - Respiratory

2 years
Not Disclosed
10 Nov. 21, 2024
Job Description
Job Type: Full Time Education: MD/DO/PhD/Pharm.D/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

Who We Are

At Teva Pharmaceuticals, we are committed to making good health more affordable and accessible, helping millions worldwide lead healthier lives. This mission unites our teams across nearly 60 countries, reflecting a rich diversity of nationalities and backgrounds.

As the world’s leading manufacturer of generic medicines and a producer of numerous products on the World Health Organization’s Essential Medicines List, our medicines benefit at least 200 million people daily. We are always striving to make a difference and welcome individuals eager to contribute to this impactful journey.


The Opportunity

We are seeking a Director of Clinical Development to oversee the development, execution, and management of global clinical programs across all phases of clinical research. This position requires leadership of cross-functional teams in a matrix environment and hands-on involvement in the preparation, review, and management of essential clinical documents.

The Director will play a pivotal role in developing clinical strategies, providing leadership for assigned asset strategies, and contributing to regulatory filings such as INDs, NDAs, and BLAs.


Key Responsibilities

Clinical Development Leadership

  • Serve as a core member of the Global Project Team.
  • Prepare and manage multiple Clinical Development Plans (CDPs).
  • Lead cross-functional clinical development teams.
  • Foster relationships with opinion leaders in respiratory, pulmonary, and atopic disease areas.

Clinical Trial Oversight

  • Support Global Clinical Operations in clinical trial initiation, resource planning, and study implementation.
  • Collaborate with Clinical Supplies Group to ensure timely procurement and planning of clinical drug supplies.
  • Ensure clinical trials comply with regulatory guidelines (ICH, GCP) and Teva SOPs.
  • Resolve safety and clinical issues in consultation with Global Drug Safety and Pharmacovigilance.

Regulatory and Strategic Contributions

  • Oversee the preparation of regulatory documents (INDs, NDAs, and other submissions).
  • Lead NDA submission teams as needed.
  • Represent Teva at regulatory meetings, scientific conferences, and advisory boards.

Collaboration and Communication

  • Partner with departments such as Regulatory Affairs, Biostatistics, CMC, Marketing, and CROs for effective execution of CDPs.
  • Author and review protocol synopses, clinical study reports, and other documents.
  • Present clinical data at investigator meetings, scientific meetings, and external venues.

Document Preparation and Analysis

  • Provide guidance on clinical result analysis and report preparation in collaboration with Medical Writing teams.
  • Author and/or review abstracts, posters, and manuscripts for publication.

Your Experience and Qualifications

Education and Experience:

  • MD, DO, or equivalent; PhD, PharmD, or DVM with proven track record will also be considered.
  • Minimum of 2 years’ experience in pharmaceutical clinical trials or related areas.
  • Relevant industry experience in the respiratory/pulmonary/allergy therapeutic area is strongly preferred.

Skills and Competencies:

  • Excellent interpersonal, verbal, and written communication skills.
  • Strong ability to manage multiple priorities and tasks in a fast-paced environment.
  • Proficiency in regulatory requirements and clinical development strategies.

Travel Requirements:

  • Up to 30% travel (domestic and international) as needed.

What We Offer

Comprehensive Benefits:

  • Health Insurance: Medical, Dental, Vision, and Prescription coverage starting Day 1.
  • Retirement Savings: 401(k) with up to 6% employer match and 3.75% annual Defined Contribution.
  • Paid Time Off: Vacation, sick/safe time, 13 paid holidays, and 3 floating holidays.

Wellness and Additional Perks:

  • Company-paid Life & Disability Insurance.
  • Tuition Assistance, Employee Stock Purchase Plan, and Lifestyle Spending Accounts.
  • Family-friendly benefits, including paid parental leave and family-building support.

Role Details

  • Location: Hybrid (West Chester, PA, or Parsippany, NJ office) 3 days/week. Remote work may be considered for the right candidate.

Already Working @Teva?

Current employees should apply via the internal career site on Employee Central for priority consideration. Contact local HR/IT support for assistance with access.


Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to providing equal employment opportunities, ensuring a workplace free from discrimination based on age, race, religion, gender, disability, or other protected statuses. We prioritize a diverse and inclusive environment.

If accommodations are needed during the recruitment process, please notify us. All accommodation requests will be handled confidentially.


Important Notice to Employment Agencies

Teva Pharmaceuticals does not accept unsolicited CVs/resumes from agencies without a valid written agreement. Unsolicited referrals will be considered property of Teva, and no fees will be paid.


Join Teva and contribute to transforming global health.