Vice President- Global Clinical Pharmacology

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Job Type

Full-time

Description

VP, Global Clinical Pharmacology

Hybrid/New Providence, NJ

Transforming what patients can expect from cancer therapy takes passion and a strong dedicated team. When you join ADC Therapeutics, you will join a group of talented people who share this mission.

Why ADC Therapeutics

ADC Therapeutics (NYSE): is a commercial, global leader and pioneer in the field of antibody-drug conjugates (ADCs) with a constantly expanding technology toolbox. We are experts in the lifecycle of ADCs - starting with creation all the way through to commercialization. We have a robust pipeline of ADCS in clinical trials for both hematologic and solid tumor cancers. Our CD-19-directed ADC for relapsed/refractory non-Hodgkin lymphoma, ZYNLONTA (loncastuxamab tesirine lpyl) has been approved in the United States and is awaiting approval in the European Union. ZYNLONTA is also being evaluated in combination with other anti-cancer therapeutics to determine if it has potential to treat an even broader range of patients. We are a team of almost 300 patient-focused, purpose-driven employees who carry out our mission in a flexible work environment. If you're interested in making a difference in the lives of patients worldwide with a team of like-minded colleagues, come join us on our journey!

To learn more about ADC Therapeutics, please visit us at https://adctherapeutics.com/ and follow us on LinkedIn.

What You'll Do:

As the Vice President of Global Clinical Pharmacology, this crucial position will be responsible for leading the clinical pharmacology programs for all projects and will be the key expert on all clinical pharmacology and pharmacometrics matters relating to these projects. This includes leading clinical pharmacology and pharmacometrics strategy, ensuring coverage of all pharmacokinetic and modeling and simulation aspects, and the design of clinical pharmacology studies. In addition, the role will lead interactions with regulatory authorities, writing of clinical pharmacology sections in the dossiers and answering questions in connection with submission procedures. The industry-experienced person undertaking this global role will have a strong pharmacokinetic/pharmacometrics knowledge and will work in close collaboration with non-clinical, Research and all Clinical R&D functions.

This position will report to the Chief Medical Officer and be based in our New Providence, New Jersey office and can work a hybrid schedule. This role will partner with global colleagues and will be expected to travel as needed to ADCT office locations and for other business-related meetings.

Job Responsibilities:

• Lead, mentor, and develop a high-performing pharmacology team, attracting and retaining top talent in the field.

• Develop and implement strategic plans for the pharmacology department, aligning with the company's goals to advance the development of oncology therapeutics.

• Foster team work to ensure timely and high-quality deliverables, demonstrate efficient and clear decision making, and foster principles and values that place patients and quality first.

• Partner closely with cross-functional teams, including clinical development, regulatory affairs, and business development, to ensure seamless integration and progression of drug development programs.

• Oversee all pharmacological studies, including the design, execution, and interpretation of research projects.

• Lead data analysis to characterize the PK profiles, and modeling of exposure-response relationships for safety and efficacy in support of dose justifications, decisions, and future study designs.

• Assess intrinsic and extrinsic covariate effects that may influence the PK/PD profile and provide actionable insights.

• Maintain state-of-the-art fluency in emerging modeling and simulation approaches and technologies through awareness of emerging literature and involvement with external training and incorporate those techniques in how the team operates.

• Provide strategic input to global regulatory authority documents, including clinical trial protocols, investigator brochures, regulatory queries, and submission dossiers, and represent the company in global board health meetings.

• Consistent with corporate needs and direction, to routinely present findings both internally and externally, and to support messaging at scientific/medical congresses and in peer-reviewed journals.

• Ensure that all pharmacological activities comply with regulatory requirements and industry best practices, maintaining the highest standards of research integrity and safety.

• Develop internal working standards and procedures, as needed.

Requirements

Who You Are:

• MD/DO or Ph.D. in Pharmacology, or pharmaceutical science, or related fields with a strong focus on cancer research.

• A minimum of 12 years of experience in the biotechnology or pharmaceutical industry, with a proven track record in oncology drug development.

• Demonstrated leadership and management experience, with the ability to inspire and guide teams towards achieving strategic objectives.

• Thorough understanding of general clinical pharmacology (including the design and conduct of clinical trials), interpretation of PK, PK/PD, population PK methodologies and related data interpretation, and the use of biomarkers in clinical development.

• Functional scientific knowledge of clinical pharmacology, pharmacokinetics and dynamics, interpretation of basic safety pharmacology and toxicology data, surrogate marker identification and application, PK/PD drug interactions, in vivo/vitro models and population pharmacokinetics and PK/PD modeling.

• Working knowledge of pharmacokinetic program and software analysis (such as WinNonlin, SAS, etc.) along with PK modeling and computer skills in scientific graphing.

• Must have experience in full clinical pharmacology programs and in-depth understanding of full clinical development.

• Experience in all stages of clinical development, particularly Phase 1 dose escalation studies.

• Experience working with antibody drug conjugates/biopharmaceutics strongly preferred.

• Regulatory experience and knowledge including representation and clinical pharmacology leadership at regulatory authority meetings. IND, CTA submission, ICH Good Clinical Practice, EMEA/FDA Guidelines and in-depth knowledge of and experience with global clinical pharmacology regulatory requirements.

• Experience in worldwide product registration and global bridging strategies are advantageous.

• Excellent communication and presentation skills with demonstrated ability to effectively present clinical pharmacology data, development plans and strategies to various audiences in both verbal and written form.

• Ability to create publications according to international scientific standards.

• Excellent interpersonal skills, including a positive and constructive attitude and ability to effectively work in a project matrix environment. Ability to negotiate, influence, and quickly earn credibility across other functional areas.

• Experience working in multifunctional teams and ability to work collaboratively within matrix management environment. Excellent networking and relationship building ability for successful cooperation with internal and external partners.

• Sound judgement, attention to detail, analytical mindset, and timeliness for work product delivery.

• A commitment to ethical scientific research and a passion for advancing the development of new treatments for cancer patients.

• Willingness to travel for periodic in-office meetings and other domestic or international travel as necessary

Attention: Search firms/Third-party recruitment agencies

The People team manages the recruiting for all positions at ADC Therapeutics. We will only accept résumés from a search agency/recruiter if we have a signed agreement in place and we have formally requested your help on a specific role. Forwarding unsolicited resumes on behalf of potential candidates and/or vendor engagement requests to ADC Therapeutics hiring managers is strictly prohibited. Unsolicited résumés sent to ADCT will be considered property of ADCT. We will not be responsible for any fees associated should we hire from unsolicited résumés.

Please send all emails and requests to recruiting@adctherapeutics.com.