Job Description

Job Id
290141
Hyderabad, Andra Pradesh, India
Job Type
Full-time

Work Your Magic with us!



Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.



United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.



Scientific Director, Clinical Pharmacology


Scientific Director, Clinical Pharmacology position in Quantitative Pharmacology within the broader Clinical Measurement Sciences organization is a strategic, scientific, and cross-functional role, leading the Clinical Pharmacology (CP) Expert Team, responsible for developing and executing clinical pharmacology and Model Informed Drug Development (MIDD) strategies from the early to late-stage clinical development. This role represents the CP Expert Team to the global cross functional drug discovery and development project teams, in close collaboration with colleagues in Biostatistics, Data Sciences, Clinical Biomarkers and Diagnostics, Research, Clinical Development and other colleagues within the R&D organization.


The CP Expert Team Lead provides strong leadership for integrating individual functional contributions, developing clinical pharmacology strategy in alignment with the overall clinical development plan, and executing the program strategy/plan. The scope includes programs from exploratory development (ED) through life cycle management, encompassing large and small molecule therapeutics/drug candidates across different therapeutic areas.


KEY ACCOUNTABILITIESEnsures that CP strategy is developed, aligned (with cross-functional development plans), endorsed and executed to support the indication, patient population, and phase of development while taking into account the competitive landscape Represent clinical pharmacology and promote MIDD with internal and external stakeholders Provides in-depth CP, PK and PK/PD advice and expertise and lead clinical pharmacology expert team and deliver on + Dose and posology decisions, from FIH starting dose through submission and beyond
+ Fit-for-purpose CP package including dose, dose regimen, and adjustment for specific conditions and specific populations, exposure-QTc assessment and immunogenicity assessment in collaboration with other function lines at appropriate stages of development
+ Develop and execute MIDD strategies/plans in collaboration with pharmacometrics and other functions
+ PK/PD data analysis, interpretation, and presentation
+ Related sections of major clinical and regulatory documents (e.g. clinical protocols, IBs, CTDs, INDs, NDAs, IMPDs, briefing books)
Contribute to due diligence projects, if needed


EDUCATION/LANGUAGES

7+ years (Bio)pharmaceutical industry and/or postdoctoral experiences with clinical drug development experience Doctorate degree (PhD, PharmD or MD) relevant in the related disciplines of clinical pharmacology, pharmaceutics, pharmacometrics, statistics, engineering or mathematics Fluency in English

PROFESSIONAL SKILLS & EXPERIENCE

Strong understanding of clinical drug development strategies, and quality related requirements in drug development in GXP-related areas. Deep knowledge in CP, i.e., PK, ADME, posology, quantitative translational sciences, etc. Excellent knowledge of regulatory requirements and submission across the main regions Good understanding about translational sciences such as quantitative pharmacology, safety and biomarkers. Clear evidence of ability to adapt to changing business needs by prioritizing multiple tasks. General knowledge of oncology, immuno-oncology, and/or immunology, and more in depth understanding of biology and pharmacology is a plus. Hands on modeling expertise is a plus. Strong interpersonal skills and proactivity to cultivate a network of productive relationships in an international matrix environment. Demonstrated ability for productive collaboration in a multi-discipline team, using effective communication and taking personal accountability for timely delivery of results. Strong presentation, communication, and organization skills. Ability to communicate technical results to stakeholders. have a broad scientific understanding across the translational sciences and drug development along with excellent team-building skills and strong collaborative & strategic capabilities.

What we offer:

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!



and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!





US Equal Employment Opportunities

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

Notice on Fraudulent Job Offers
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Applicant Profile

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WHAT WE OFFER
Money makes the world go round. But at our company there's more than just financial rewards. We offer a range of attractive benefits to help you work your magic.
Saving & Finacial
Our 401(k) Plan includes a generous company-matching contribution and an additional discretionary contribution each year.
We also provide tax-advantaged accounts for you to save for healthcare, commuting expenses, company-provided and buy-up life insurance to help you protect your financial future.
Health & Wellness
We offer comprehensive medical, dental, & vision coverage-including virtual care through Telehealth & free behavioral health counseling sessions through our Employee Assistance Program.
We also offer a wellness incentive program and personalized support to help you navigate and use your benefits.
Voluntary Benefits
Our voluntary benefits provide additional protection from the high costs of healthcare not covered by health insurance.
We also have discount programs that offer exclusive savings on everything from auto, home, and pet insurance to low-interest personal loans.
Work/Life Support
We have several programs to support your work/life balance, including generous paid time off, back-up day care services, education assistance, and more.
OUR RECRUITING PROCESS
Depending on the position (level, functional area, country) the process can vary slightly.
You apply
Complete your online application for your preferred role(s) that match your interests and qualification. If you cannot find a suitable role please join our Talent Zone and stay connected for your next career opportunity.
We screen
We review your application and if we determine that you are a good fit we will move you to the selection process.
We assess
You are interviewed by phone, via video and/or face to face.
Mutual agreement
Ideally you are the perfect match for us! We hope you consider us as your new employer.
Work your magic!
To guarantee you a smooth start our onboarding preparation begins.
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