Job title: Senior Director Clinical Development – Psychiatry
Company: Teva Pharmaceuticals
Job description: Who we areTogether, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.The opportunityThe Senior Director of Clinical Development is responsible for strategic leadership, execution, and oversight of global clinical development programs across all phases of clinical research. This role requires a seasoned professional capable of managing complex clinical programs and leading multidisciplinary teams in a highly matrixed environment. The Senior Director will provide visionary guidance to study teams, ensuring the alignment of clinical strategies with overall program objectives. The individual is expected to demonstrate extensive experience in the end-to-end management of clinical research projects, including the preparation, review, and approval of key documents such as protocols, Investigator’s Brochures, clinical study reports, and regulatory submission materials. This role is critical in designing and implementing clinical development plans, leading asset strategies, and driving collaboration with key internal stakeholders across functions such as commercial, regulatory, pharmacovigilance, manufacturing, and pre-clinical development. The Senior Director will serve as a clinical leader for INDs, NDAs, BLAs, and other global regulatory filings, while also cultivating relationships with thought leaders and stakeholders in assigned therapeutic areas.How you’ll spend your day
- Serve as a senior leader within the organization and a core member of the Global Program Team, driving strategic clinical development initiatives.
- Develop, oversee, and manage multiple Clinical Development Plans with a focus on long-term program success and alignment with corporate goals.
- Lead cross-functional clinical development expert teams, ensuring optimal integration of efforts across all departments.
- Provide clinical leadership and oversight for study design, initiation, resource planning, implementation, and completion of global clinical trials.
- Represent clinical development in high-level internal and external meetings, including Investigator Meetings, advisory boards, and regulatory authority discussions.
- Lead interactions with global regulatory authorities, providing clinical expertise and strategic direction to facilitate successful submissions.
- Drive matrix collaboration with functional areas such as medical affairs, health economics, regulatory, commercial, and supply chain teams to ensure cohesive program execution.
- Oversee the preparation and review of clinical documents, including Protocols, Clinical Study Reports, Investigator’s Brochures, and global regulatory filings.
- Foster and maintain strategic partnerships with key opinion leaders, external collaborators, and academic institutions to advance clinical development objectives.
- Serve as medical monitor, providing high-level medical oversight, including study design, data analysis, patient safety, and CRO engagement.
- Proactively identify and mitigate risks across clinical programs, ensuring quality and compliance with all regulatory requirements.
- Mentor and develop clinical development team members, promoting a culture of excellence, innovation, and accountability.
Your experience and qualificationsEducation Required
- MD with board certification in psychiatry (preferred) or other relevant specialties.
- Advanced training or specialization in clinical research, drug development, or related fields is highly desirable.
Experience Required
- A minimum of 3 years of pharmaceutical/biotechnology industry experience in clinical development, with a proven track record of leading programs through all stages of development, including regulatory approvals.
- Extensive experience managing and mentoring cross-functional teams in a matrix environment, with demonstrated ability to drive alignment and deliver results.
- Expertise in psychiatry or a related therapeutic area, with deep knowledge of disease-specific clinical and regulatory landscapes.
- Strong strategic thinking and decision-making skills, with the ability to balance short-term needs with long-term goals.
- Experience in global clinical trials, regulatory interactions, and dossier preparation for INDs, NDAs, and BLAs.
- Advanced understanding of clinical trial design, data analysis, and risk management practices.
Skills Required
- Exceptional interpersonal, leadership, and communication skills with the ability to influence across all organizational levels.
- Strong analytical capabilities and problem-solving skills to address complex clinical development challenges.
- High proficiency in managing multiple, simultaneous projects with aggressive timelines in a dynamic environment.
- Fluent in English, with superior oral and written presentation skills for internal and external audiences.
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 3 days a week but will consider the right candidate to work remotelyEnjoy a more rewarding choiceWe 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.
Already Working @TEVA?If you are a current Teva employee, please apply using the internal career site available on “Employee Central”. By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply:The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.Teva’s Equal Employment Opportunity CommitmentTeva Pharmaceuticals is committed to equal opportunity in employment. It is Teva’s global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.Important notice to Employment Agencies – Please Read Carefully
Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Expected salary:
Location: Parsippany, NJ
Job date: Thu, 30 Jan 2025 01:11:37 GMT
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