Head of Bioanalytical Development
Intarcia Therapeutics, Inc., is a rapidly emerging biopharmaceutical company committed to developing innovative therapies that merge medicine with technology.
At Intarcia, we seek to transform the standard of care and improve patient outcomes in major therapeutic categories for serious chronic diseases, such as diabetes. We successfully completed our Phase 3 clinical trial program for our lead product, ITCA 650, and submitted our New Drug Application filing in the U.S. in 2016.
Additionally, we are developing a pipeline of products for our proprietary Medici Drug Delivery System™, comprised of three unique technologies: 1) A stabilization technology that allows for proteins, peptides, antibody fragments, and other highly potent small molecules to be stabilized at or above human body temperatures for up to three years or more; 2) A matchstick-sized osmotic mini-pump that is placed just under the dermal layer of skin to deliver a continuous and consistent flow of medication; and 3) A placement technology including proprietary tools designed to provide an optimal user experience.
We Are Growing
Since our 2012 round of financing, much progress has taken place at Intarcia, including significant enhancements to our world-class manufacturing facility, the opening of our new headquarters in Boston’s Innovation Center, and the diversification of expertise on our Board of Directors and Leadership Team through new senior leaders who contribute vital new capabilities and experiences.
A key element of pride during our progress has been our ability to remain fully independent throughout our rounds of financing so that we continue to have full strategic and executional control over all aspects of our rapidly evolving business. While we are always accountable to our stakeholders, we are – and intend to remain – the driving vision and force behind our progress and our ultimate success.
The Head of Bioanalytical Development will provide leadership in design, development, and oversight of PK, PD and immunogenicity bioanalysis assessments, in support of pre-clinical and clinical development programs, and regulatory development for products from nonclinical development to filing NDA. This role reports into the Vice President of Clinical Pharmacology.
Duties and Responsibilities:
- Lead the development of a plan/strategy for pre-clinical and clinical PK, PD (biomarkers) and ADA bioanalysis;
- Execute the pre-clinical and clinical PK, PD. and immunogenicity bioanalytical; immunogenicity strategies in collaboration with CRO’s;
- Interact with a cross functional team in Clinical Development, Clinical Pharmacology, Discovery and Toxicology colleagues;
- Planning, preparing and reviewing drug development plans with a focus on PK, biomarker and immunogenicity bioanalytical assessments for nonclinical and clinical development projects. This includes assisting with the determining scope, design, planning and analysis of nonclinical development, clinical pharmacology and clinical development studies. Responsibilities include describing results of validation reports and sample analysis reports in various regulatory documents (IND’s, End of Phase II meeting, pre-NDA, NDA’s, IB’s, etc.).
- Leading assay development for PK, PD and immunogenicity (ADA, Nab, cross-reactivity to relevant endogenous compounds);
- Leading assay validation for PK, PD and immunogenicity (ADA, Nab, cross-reactivity to relevant endogenous compounds);
- Represent Intarcia in interactions with regulatory agencies and respond to regulatory inquires related to PK, biomarker and immunogenicity assessments; and,
- Participate in the evaluation of potential in-licensing candidates. Serve as early development sciences expert representative on teams evaluating candidates for in-licensing or risk sharing opportunities.
- Ability to work effectively independently and in multi-disciplinary teams, with peers, and with senior management to move projects forward;
- Experience interacting with regulatory agencies including being directly involved in the review process;
- Must have been directly involved with successful major regulatory filings;
- Preferably have had hands on experience preparing and writing regulatory documents from IND through NDA, specifically 2.7.1 and 2.7.2;
- Proven ability to manage CRO's and consultants;
- Excellent written and oral communication skills;
- Ability to think critically and solve problems;
- Ability to navigate and be successful in a fast-paced, highly-matrixed work environment; and,
- Embody and model Intarcia’s core values.
- Required/Preferred Education and Licenses
- This position requires an MS or Ph.D. in biochemistry, chemistry, or a related science and 10+ or more years of related experience developing/troubleshooting, method validation, and analysis of study samples for PK and immunogenicity bioanalytical assays in a regulatory environment in the pharmaceutical or biotechnology industry.