Senior Director, Head of Clinical Pharmacology

The company, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple PRO-XTEN ® dual-masked T-cell engagers across validated targets in solid tumor indications. The company also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies.

The company has exclusive rights to the universal PRO-XTEN ®  masking platform for oncology and infectious disease. PRO-XTEN ®  is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company.

We believe the success of our colleagues drives the success of our mission. We are committed to creating a company where everyone feels supported and encouraged to give their best.

THE OPPORTUNITY

The company is looking for an experienced Sr. Director of Clinical Pharmacology to lead the technical and operational aspects of the department in support of programs across all stages of preclinical and clinical development. You will work across the company Bio's portfolio of infectious disease and oncology programs, providing hands-on leadership while managing and developing a team. In this role, you will work collaboratively with internal and external cross-functional teams and consultants to support the successful and timely advancement of drug development programs. You will evaluate and apply best practices and innovative techniques to foster successful execution and outcomes of clinical studies. You will report to the VP of Translational Development.

WHAT YOU'LL DO

• Oversee clinical pharmacology and translational PK/PD operations and deliverables across all stages of development for both infectious disease and oncology programs

• Represent clinical pharmacology and translational PK/PD as technical expert on cross-functional project teams and provide strategic input to program advancement

• Develop fit-for-purpose clinical pharmacology strategies to enable development and regulatory decisions from pre-IND through market authorization

• Select and execute appropriate modeling and simulation approaches (PK/PD, PopPK, exposure-response) to inform dose selection, optimization, and justification across all phases of drug development

• Author and provide technical input for regulatory documents and submissions (protocols, IBs, briefing packages, INDs, NDAs/BLAs) and responses to questions

• Work collaboratively with cross-functional teams, including clinical research, clinical operations, biomarkers, bioanalytical, biometrics, CMC, research, and regulatory in support of program advancement

• Establish and manage collaborations with external vendors and collaborating partners

• Generate and manage departmental budget(s) and optimize resource allocation across multiple programs

• Manage and develop the Clinical Pharmacology and Translational PK/PD team, including hiring, mentoring, and building departmental capabilities to support organizational needs

WHO YOU ARE AND WHAT YOU BRING

• PhD, PharmD, or MD with relevant training in clinical pharmacology, pharmacokinetics, pharmaceutics, or related field with 13+ years industry experience in Clinical Pharmacology, DMPK and/or related fields preferred

• Mastery of nonclinical and clinical pharmacokinetic concepts and methodologies with deep understanding of multidisciplinary drug development requirements

• Expertise in PK/PD, PopPK and exposure-response modeling

• Extensive experience leading translational and clinical pharmacology work from candidate selection through market authorization

• Strong understanding of regulatory requirements and experience contributing to regulatory submissions and engagements

• Working knowledge of bioanalytical techniques in support of clinical development of small molecules and biologics

• Experience with biologics, including monoclonal antibodies and bispecifics required; experience in oncology indications strongly preferred

• Proficiency using standard PK analysis and graphing programs

• Proven ability to manage and develop teams

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WHO WE ARE AND WHAT WE OFFER

The expected salary range for this position is $235,500 to $329,500 per year. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.

The company's compensation and benefits are aligned with the current market and commensurate with the person’s experience and qualifications. All full-time employees receive a package that includes compensation, bonus and equity as well as many other the company benefits and perks such as health and welfare benefit plans, non-accrual paid time off, company shut down for holidays, commuter benefits, 401K match and lunch each day in the office.

Applicants must currently be authorized to work for any employer in the U.S.  We are unable to sponsor or take over sponsorship of an employment Visa at this time.

All employment decisions at the company are based on legitimate, non-discriminatory business requirements, job duties and individual qualifications. Employment decisions are made without regard to any legally protected characteristics.

This commitment extends to all management practices and decisions, including recruitment and hiring, compensation, appraisal systems, promotions, training and career development programs.  The company also strongly commits to providing employees with a work environment free of unlawful conduct or harassment.

The company Human Resources leads recruitment and employment for the company. Unsolicited resumes sent to the company from recruiters do not constitute any type of relationship between the recruiter and the company and do not obligate us to pay fees should we hire from those resumes. We ask that external recruiters and/or agencies not contact or present candidates directly to our hiring manager or employees.

For hires based in the United States, the company, participates in E-Verify .

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