Sr. Director, Pharmaceutical Sciences and Analytical Development

At Tarsus, we are looking for inspired individuals who are motivated to grow professionally, while building a best-in-class pharmaceutical company with a differentiated approach. Join us in advancing our mission to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients.

Who is Tarsus? We are a biopharmaceutical company focused on the development and commercialization of therapeutic candidates designed to address diseases with high unmet need across therapeutic categories including eye care, dermatology, and infectious diseases.

We are advancing our pipeline to address several diseases with high unmet need across a range of therapeutic categories, including eye care, dermatology, and infectious disease prevention. XDEMVY™ (lotilaner ophthalmic solution) 0.25% is FDA-approved in the United States for the treatment of Demodex blepharitis. We are also investigating TP-03 for the treatment of Meibomian Gland Disease, which is currently being studied in a Phase 2a clinical trial. In addition, we are developing TP-04 for the potential treatment of Rosacea and TP-05, an oral tablet for the prevention of Lyme disease. TP-04 and TP-05 are both currently being studied in Phase 2a clinical trials to evaluate safety, tolerability, and proof-of activity.

If you are looking for an opportunity to work alongside a diverse team with deep expertise, have a curious and driven mindset, and a passion for helping patients, then join our Tarsus community and help build our unique culture!

About the Role

Reporting to the Vice-President of Manufacturing Operations and Supply Chain, the Sr. Director, Pharmaceutical Sciences will be responsible for leadership of the Pharmaceutical Science and Analytical Development teams and will have ownership of R&D operational support for early and mid-phase programs including formulation development, process development and analytical development, management of CMOs, process tech transfer and scale up. 

The person in this role will work closely with Quality, Regulatory Affairs, Clinical Supply Chain and Procurement to ensure successful external execution across API, Drug Product and Packaging Operations for early and mid-phase products.

Let’s talk about some of the key responsibilities of the role:

• Lead team responsible for formulation development, process development and analytical development for the company’s early and mid-phase clinical candidates.
• Responsible for CMO management for early and mid-stage programs, including technology transfer, analytical support and CTM production at appropriate CMOs for early and mid-phase programs.
• Lead R&D stage operational support utilizing an in-house laboratory for formulation development, process development and analytical testing and method development.
• Establish and manage specifications, expiry and retest periods for drug substances and drug products.
• Work closely with the Manufacturing Operations team providing that link between Development and Commercial manufacturing/packaging. Ensure that processes developed are scalable to produce clinical and commercial drug products in compliance with cGMPs and regulatory guidance. Provide input and guidance to the manufacturing/packaging decision-making processes prior to filing and validation.
• Support the Operations Leadership with the implementation of key technical projects that are identified as part of the company's objectives in CMO’s and provide management with accurate and timely information necessary to make strategic, investment and operating decisions.
• Maintain all appropriate corporate standards for lab safety and hazardous material management; execute daily operations with an approach designed to minimize risks and hazardous waste streams.
• Work with cross functional teams and contribute to overall project goals, study designs, etc.
• Provide effective leadership including development and implementation of objectives and business strategies; selecting key personnel and motivating members of the functional area; challenging employees to develop as leaders while serving as a role model and mentor; supporting workforce diversity, quality and safety and supporting managers in the management of their employees which support the achievement of individual, department, and business objectives.

Skills and Qualifications Required for this Dynamic Leader:

• B.S. /M.S./Ph.D. in one of the relevant Engineering or Science fields
• Masters/PhD/BPharm strongly desired.
• Strong understanding of technical/scientific challenges as those apply to the API process development, design of novel sterile products for various routes of administration and transition from proof-of-concept stage to pivotal stage products.
• Lean/Six Sigma qualification at Green Belt or above obtained and certified by an Internationally Recognized body in a pharmaceutical setting an advantage.
• 15 years of progressive responsibility in early and mid-stage stage product development and a track record of developing innovative products with a minimum of 7 years being at an associate director/director level. (Doctorate degrees require a minimum of 8 years total experience.)
• Preferable experience in all the following areas: Small Molecule and biologics API, Sterile ophthalmic dosage forms, Solid Oral Dose, Topical Dermal formulations, and novel drug delivery systems
• Must have strong understanding of project management systems and tools, strong business, and financial skills.
• Established track record with evidence of excellent people management experience, problem solving, collaborative, leadership, and communication skills.
• Strategic Leadership - Translates corporate vision and strategy into departmental goals and objectives; adjusts plans and tactics to meet changing departmental priorities and circumstances; utilizes market data.
• Successful candidate will be high-energy, possess a learning orientation and the ability to work in a fast-paced environment.
• Strong communication and change management skills required, in addition to ability to build strong relationships both vertically and horizontally.
• Proven ability to escalate difficult issues and make tough decisions.

A Few Other Details Worth Mentioning:

• The position will be based in our beautiful Irvine office, complete with a courtyard, table tennis, snacks and drinks, and occasional catered meals. We provide a hybrid work environment. Remote work is an option for the right candidate.
• We are passionate about our culture! Our Tarsans live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impact!
• This position reports directly to our Vice-President of Manufacturing Operations and Supply Chain.
• Some travel may be required – up to 30-50%.

At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $206,200 - $288,800 plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days. For more details regarding Tarsus benefits, please visit: https://alliantbenefits.cld.bz/tarsus2024BenSnapshot 

#LI-Hybrid

#LI- Remote