Open Positions: Executive Director, Clinical Formulation R&D
Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body’s own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of PROTAC® protein degraders against validated and “undruggable” targets, the company has two clinical-stage programs: ARV-110 for the treatment of men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.
The Executive Director will serve as the leader of the clinical product development team and conduct manufacturing development and scale-up for Arvinas small-molecule drug candidates for the clinic and commercial market. Working closely with exploratory pharmaceutics, process chemistry, clinical supply logistics, clinical operations, and quality assurance, the incumbent will be accountable for formulation/process development and manufacture of drug product in development through to the commercial market. Working through CDMOs, responsibilities include clinical supply manufacture, scale-up activities, validation campaigns, technology transfer, and validations. The candidate will be a process development expert with direct experience in optimizing and scaling-up robust formulations applicable to solid oral and parenteral dosage forms of small molecules. The incumbent will ensure all activities occur in compliance with the appropriate SOPs and regulations.
With two compounds moving into later stage clinical development and one more entering the clinic in mid-2021, Arvinas leads the field of protein degradation – one of the newest areas in pharmaceutical research and development, and one with the potential to have profound impact on human health. This position represents the chance for a motivated scientist to have an immediate, direct impact on the path PROTAC® molecules take towards fulfilling the promise of this mode of therapeutic intervention.
This position reports to the head of Technical Operations and will be located at our headquarters in New Haven, CT. Flexible working arrangements are possible.
Key responsibilities of this role include, but are not limited to:
- Provide leadership, technical expertise, and specialized knowledge in process/formulation development and drug product manufacturing to support the Arvinas portfolio of clinical drug assets.
- Own drug and product development strategy, providing clear messages to management on risks and mitigation strategies.
- Provide functional leadership in terms developing budgets, projecting resource needs, developing personnel and long-term planning.
- Develop and realize a final formulation and process for clinical and commercial phase products. Drive projects from concept to commercialization.
- Responsible for the identification and selection of required CMO/CDMOs to achieve project goals. This includes the generation of RFPs and vendor evaluation.
- Through the services of contract manufacturing vendors, maintain accountability for development, optimization, scale-up, and technology transfer of scalable and robust processes applicable to oral and parenteral drug products.
- Evaluate data associated with characterization and stability testing of drug products that assess suitability of a drug product for an intended purpose. Establish appropriate specifications for drug product and their intermediates.
- Implementation of a QbD approach to product development and responsible for effective risk assessments/FMEA for manufacturing processes.
- Ensure supply of bulk clinical drug product for clinical supply of clinical trials. Work with the Quality function to manage release of drug products. Collaborate with Quality Group to ensure preparedness for PAI / GMP inspections at CDMOs at appropriate stage.
- Convert data on formulations/products into knowledge required for regulatory filings. Draft the relevant sections of INDs and NDAs. Respond to inquiries from regulatory bodies.
- Interact effectively and build successful relationships with members of the Arvinas development and project management staff. Facilitate communication with internal development partners in functions like Clinical Development, DMPK, Drug Safety, Regulatory, QA, Project Management etc.
- Fifteen plus years of relevant experience in the pharmaceutical industry.
- Demonstrated leadership of developing and manufacturing solid oral and intravenous dosage forms for use in clinical studies through commercialization.
- Hands-on experience in formulation development, process optimization, scale-up, technology transfer, and manufacturing of solid oral and parenteral dosage forms of small molecules.
- Familiarity with quality-by-design (QbD) approaches to drug product development
- Must be an experienced leader in a cross functional setting that requires frequent interaction with internal and external stakeholders relevant to early & late-stage product development.
- Demonstrated success in authoring INDs and NDAs.
- Demonstrated success in bringing a new drug product through development into commercial manufacturing.
- Working knowledge of Good Manufacturing Practices (cGMPs) and Regulatory Guidance Documents as they relate to manufacture and quality testing of pharmaceutical products.
- Experience with creating RFPs, selecting vendors and working with CDMOs for formulation development, process optimization, and manufacturing of drug product.
- Ability to multi-task and manage several projects in parallel, and effectively prioritize and deliver on short timelines.
- Proven ability to quickly adapt to changes in project direction.
- Ability to forge cross-functional working relationships with internal and external project partners.
- Excellent oral and written communications skills
- Proven ability to think creatively and obtain solutions to complex and diverse problems. Proven record of creative, productive, and insightful analysis and achievement.
- A willingness to take on challenging problem statements and acquire/apply the skills necessary to address them.
- Enthusiastic desire to roll up sleeves and dig in. Confidence in own abilities to get things done.
- Able to meet tight deadlines on multiple priorities.
- Strong analytical skills with attention to detail and accuracy.
- Customer focused with strong teamwork, interpersonal and communication skills.
- Requirement to maintain a high level of confidentiality.
- Ability to develop solutions to problems and implement them.
- A Ph.D in Chemistry, Pharmaceutics, or Engineering
Arvinas is proud to offer a competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness, and financial security of our employees and their families. Benefits include group medical, vision, and dental coverage, group and supplemental life insurance, and much more. To learn more about Arvinas, please visit www.arvinas.com.
Arvinas is an Equal Opportunity Employer.