Senior Director Clinical Pharmacology

Job title: Senior Director Clinical Pharmacology in West Chester, PA at Teva Pharmaceuticals
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 holder of this position is expected to drive high quality of Clinical Pharmacology deliverables, lead change aimed at improving the efficiency of studies and to foster and implement innovative state-of-art methodologies in clinical pharmacology/early phase clinical research. By focusing on these areas the following achievements are expected: clinical timelines will be accelerated, cost of clinical studies will be reduced and entry into Phase-2/3 studies will be done with robust comprehensive data in healthy subjects and/or patients. To be successful the candidate must demonstrate strong leadership and collaboration within the group and with other GEC functions and R&D groups.The Sr. Director spends most of her/his time doing independent technical work, leading tasks and supporting projects. The Sr. Dir CP can mentor junior team member, he/she can lead multiple projects, often will serve as a clinical lead as part of the Clinical Development Team (CDT) and being an expert in CP contributes to the overall quantitative clinical pharmacology strategy and other cross functional/department initiatives as necessary.How you'll spend your dayTravel Requirements:

• Ability to travel with overnight stays, as required

Essential Duties & Responsibilities:

• Sr.Dir CP is responsible for the CP/early clinical development deliverables for their programs teams:

• Support the clinical pharmacology strategy across their specific programs
• Generation of CP information and integration with up-to-date regulatory and scientific resources to inform decision-making and bring value to the programs.
• Planning, direction, and interpretation of clinical pharmacology studies defined in the Clinical Development Plan
• Participates in planning, writing and leading clinical pharmacology related modules of regulatory documents and application
• Supports company clinical development strategy by:

• Assessing impact of new and evolving relevant operational, scientific, and regulatory strategies and industry trends
• Keeping abreast with relevant regulations and scientific literature.
• Promotes the value of ClinPharm by sharing professional knowledge with external stakeholders
• Developing consistent CP processes.
• Responsible for financial planning/forecasting and budget management of their program.
• Represents CP with internal and external stakeholders, and at relevant governances.
• Initiates, develops, leads and participates in company initiatives to meet cross functional drug development objectives and other continuous improvement to achieve innovation in drug development, cost -reduction, time-savings, efficiency and quality business objectives.
• Represents clinical pharmacology and defend clinical pharmacology strategy and study results and interpretation at regulatory interactions.
• Follows Teva Safety, Health, and Environmental policies and procedures

This position is a hybrid role based out of our West Chester, PA office. Candidates within commuting distance to our Parsippany, NJ office will also be considered.Your experience and qualificationsRequirements:

• PhD in Clinical pharmacology, pharmacology, pharmaceutical sciences, life sciences/chemistry/biology or related fields and relevant experience of a minimum of 12 years in the pharmaceutical industry (preferred), academia or regulatory agency such as the FDA. A post pectoral fellowship can be counted towards relevant experience.
• MD and a minimum 12 years of relevant experience in the pharmaceutical industry (preferred) or post completion of degree in research or medical practice or with regulatory authorities such as the FDA.

Preferred:

• Experience/training in population PK/PD analyses.
• Experience in more than one therapeutic area and in early development
• Proven track record of delivering results, including filing of INDs and NDAs.
• Experience with software used for NCA and pharmacometric modeling preferred.

Functional Knowledge:⦁ Excellent understanding of drug development process.
⦁ Proven leadership in the transition of discovery programs into clinical development and submissions.
⦁ In-depth knowledge and expertise in developing small and large molecule therapeutics.Company/Industry Related Knowledge:

• Experience in change management
• Global/international experience, including ability to lead intercultural regionally based programs teams

Enjoy 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, and holiday.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but are 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.

The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.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 policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.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. Request a reasonable accommodation by sending an email to disabilityassistance@tevapharm.com with the nature of your request and your contact information. Only inquiries concerning a request for a reasonable accommodation will be responded to from this email address.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: West Chester, PA
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