Senior Director, Clinical Pharmacology
Location: South San Francisco, California, United States
The Senior Director, Clinical Pharmacology will be responsible for the design, execution, leadership, and implementation of Clinical Pharmacology strategy across Assembly’s hepatitis B clinical portfolio programs. The position requires extensive experience in designing and executing clinical pharmacology studies and a strong knowledge of global regulatory virology practices. The individual in this position will participate in cross-functional project teams and play a key role in preparation for and execution of interactions with global health authorities. This role will require individuals to have experience in leading a clinical pharmacology program and demonstrate strong communication and collaboration skills.
Key Responsibilities include:
- Leading the clinical pharmacology activities to characterize human pharmacokinetics, metabolism and biopharmaceutics of clinical compounds, including the design of clinical pharmacology dedicated protocols which may include which assess drug-drug interaction, absolute/relative bioavailability, hepatic/renal impairment, and TQT studies.
- Authoring/reviewing/approving clinical protocols, analysis plans, study reports and regulatory submissions
- Providing clinical pharmacology expertise and oversight during clinical study execution
- Developing high quality clinical pharmacology plans and content for global regulatory submissions, including INDs, IBs, NDAs
- Providing subject matter expertise on cross-functional project teams
- Developing and maintaining collaborative working relationships with colleagues within and outside of clinical development
Preferred Qualifications include:
- At least 13 years of experience and a PhD or PharmD with emphasis in clinical pharmacology, pharmacokinetics, or a related scientific discipline
- Proven track record of extensive experience in population modeling and simulations. Expertise with standard modelling and simulation software (NONMEM, S-Plus/R, etc) is a plus. Knowledge of other software – e.g. WinNonlin required.
- Successful experience with NDA fillings a plus
- Thorough knowledge of current and emerging scientific standards and regulatory requirements for global territories
- Excellent written and oral communication skills and ability to convey complex technical information clearly
- Confidence and ability to present to and influence senior leaders
- Ability to critically analyze problems and provide creative solutions
- Confidence and discipline to work autonomously
- Experience in the early and late stage development of small molecules
About Assembly Bio
Assembly Biosciences (NASDAQ: ASMB) is a clinical stage biopharmaceutical company with cutting-edge therapeutics potentially capable of improving millions of lives around the world. We pride ourselves on creating a culture and work environment that is scientifically driven, ambitious, and collaborative. We encourage diversity of thought that leads to great innovation and are looking to add great people to our dynamic team who are driven to transform the lives of patients. We are currently focused on the development of two intelligently designed, scientifically novel clinical platforms:
An HBV program intent on creating a new class of oral therapeutics to finally cure hepatitis B. Our program is built on ingenuity, vision and experience and has the potential to improve cure rates for individuals with chronic hepatitis B (HBV) in our lifetime. Our strong scientific expertise in discovering small molecules targeting the HBV core protein has made us a leader in the field.
A Microbiome program of potentially life-changing oral live biotherapeutics to transform the treatment of an entire range of diseases linked to the microbiome. We believe our Microbiome platform represents a best in class approach, translating naturally evolved, bacteria-host pharmacological interactions into rationally selected, live oral biotherapeutics.
Assembly Bio has a strong balance sheet and is well-positioned to advance our innovative research and potential medicines in HBV-cure and the Microbiome. Headquartered in South San Francisco, CA, Assembly Bio also operates a microbiome manufacturing facility in Groton, CT, and has offices in China.
Assembly Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. We are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
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