Senior Director Clinical Development - Respiratory

The opportunity

Senior Director, Clinical Development is responsible for the development, execution and management of several clinical programs worldwide across all phases of clinical research.

The individual will oversee study teams and will be responsible for leading cross-functional teams in a matrix environment.

The individual is expected to be able to function independently in the daily management of clinical research projects including the preparation / review of related key documents (i.

e. protocols, Investigator’s Brochures, clinical study reports, summaries for regulatory submissions).

The Sr. Director, Clinical Development will provide input to the clinical development plan and will provide leadership for assigned asset strategy, working closely with other functional areas such as commercial, regulatory, pharmacovigilance, CMC, early clinical, and pre-clinical development in this regard.

The Sr. Director, Clinical Development will be a key contributor to and responsible for the clinical leadership of INDs, NDAs, BLAs, and other global regulatory filings.

How you’ll spend your day

• Foster relationships with opinion leaders in assigned Respiratory / pulmonary / allergy disease areas.
• Work with external co-development partners, CROs and other development partners to manage ongoing and planned clinical development programs (i.

e. individual studies and multiple studies in a program, as applicable)

• A core member of the Global Project Team
• Have and maintain the expertise necessary for the clinical development of the product
• Prepares and manages multiple Clinical Development Plans
• Leads or oversees the cross-functional clinical development team
• Supports Global Clinical Operations in clinical trial initiation, resource planning, study implementation and successful completion
• Makes presentations at the Investigator Meetings and other relevant internal or external venues
• Responsible for securing the required human resources to implement the Clinical Development plan
• Works with Clinical Supplies Group to ensure clinical drug supply plans and timely procurement with the clinical supplies group
• Ensures clinical trials comply with clinical guidance, ICH, GCP, in agreement with the laws of the relevant countries and Teva Standard Operating Procedures
• Resolves safety or relevant clinical issues in consultation with Global Drug Safety and Pharmacovigilance, SVP Late Clinical Development and the Disease Area Heads, as needed.
• Oversees the preparation of documents for IND / NDA and other regulatory documents
• May lead an NDA submission team independently, as needed
• Partners cross-functionally with departments such as Regulatory Affairs, Toxicology, CMC / Formulations, Biostatistics, Legal, Marketing, Accounting / Finance, Global Clinical Operations, development partners and CROs in the execution of Clinical Development Plans (CDPs)
• Capable of analyzing and interpreting clinical results and provide a guidance to prepare high quality reports working with Medical Writing
• Working with Medical Writing team, responsible for authoring protocol synopses, providing input and direction to the review and finalization of Protocols, Clinical Study Reports and other relevant clinical documents
• Author and / or review abstracts, posters and manuscripts, present data at scientific meetings, as needed
• Represent Teva at Scientific meetings, advisory boards, KOL boards and meetings with regulatory agencies, as needed

The expectation is for the person hired into this role work in a hybrid environment out of the West Chester, PA office or Parsippany, NJ office but will consider the right candidate to work remotely

Your experience and qualifications

• MD, DO or equivalent combination of education and related work experience. PhD, PharmD, DVM with strong proven track record will be considered
• Minimum of 5 years’ experience in a pharmaceutical industry environment or related area planning / managing clinical trials, with proven ability to manage projects and / or lead project teams effectively.

MD / DO without prior industry experience but with relevant knowledge and expertise, in clinical trials will be considered

• Experience in the Respiratory / pulmonary / allergy therapeutic area is strongly preferred
• Excellent interpersonal, verbal and written communication skills. Ability to manage multiple conflicting priorities and varied concurrent tasks, 2 years of managerial experience preferred
• Strong sense of urgency and understanding of time pressures, ability to thrive and enjoy working independently in a fast-paced, multi-tasking environment

Travel :

Approximately 30%, both domestic and International, as needed

Enjoy a more rewarding choice

We offer a competitive benefits package, including :

• Comprehensive Health Insurance : Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings : 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off : Paid Time Off including vacation, sick / safe time, caretaker time, 13 paid Holidays and 3 paid floating holidays.
• Life and Disability Protection : Company paid Life and Disability insurance.
• Additional benefits include, but not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.
30+ days ago