POSITION TITLE: Director/Sr. Director, Clinical Operations
REPORTS TO: VP, Clinical Operations
POSITION TYPE:  Full-time, exempt position

About Us!
PharmaIN Corporation is a clinical stage biopharmaceutical company dedicated to developing first- and best-in-class subcutaneous therapies through its proprietary peptide engineering platform. Through the company’s expertise in target-specific biology, peptide drug design and innovative drug delivery, PharmaIN is developing novel treatments for patients with advanced cirrhosis and cancer. Come join an exciting and rapidly growing team dedicated to discovering transformational therapies for patients with severe unmet medical needs. At PharmaIN, our employees are passionate about their work and believe in the power of teamwork, collaboration, and mutual respect. Visit: www.pharmain.com

About you!
We are seeking a demonstrated leader who is driven and passionate for research and development. You will lead programs, product development, and associated activities in alignment with company strategy that results in a regular introduction of innovative, unique and differentiated programs. You will drive R&D efforts to enhance current products and develop new and differentiated peptide drug products mainly in the oncology space. Responsible for providing leadership for all aspects of product development efforts through IND enabling studies and initial regulatory filings. Directly responsible and accountable for leading Team Members in the proper execution of their related areas of responsibilities and in achieving company strategic goals (OPSP).

Essential Functions and Responsibilities:
Lead company-wide R&D efforts to enhance current products and develop new technologies

• Develop and manage R&D operating budget
• Provide management, leadership, and direction to Team
• Provide support to Team Members professional development
• Delivers innovative, unique new products – on time and on a regular and consistent basis
• Delivers consistent development and improvement of existing products
• Gathers competitive information that supports product development efforts
• Direct research efforts on current products with collaborators: universities, consultants, key customers
• Develop target product profiles

Establish and direct strategic plans for development

• Prospect for new and existing technologies available in the marketplace
• Assist in rights and licensing negotiations (scientific analysis)
• Assures a consistent introduction of innovative, unique new products, services and delivery systems
• Lead peptide drug development and optimization strategies by integrating chemistry, in vitro and in vivo characterization studies of lead candidates
• Optimize peptide lead candidate against and established target product profile
• Design and implement primary pharmacology and nonclinical studies in support of IND filings
• Integrate discovery and development activities with early formulation development, manufacturing and stability studies
• Design and coordinate IND enabling in vitro and in vivo toxicology studies in support of regulatory filings
• Liaise with clinical development team to inform protocol development for Phase 1 exploratory clinical studies

Direct and execute the company’s intellectual property strategy

• Define, identify and pursue IP strategies
• Prepare patent disclosures, patents and supporting documentation
• Liaise with patent attorney to submit patent documents in a timely manner

Provide scientific regulatory support for new product introductions

Your responsibilities will include:

• Develop Strategic Plans: Create and implement research strategies that align with company goals.
• Lead Your Team: Mentor and guide a team of research scientists to achieve excellence.
• Oversee Experiments: Design, execute, and analyze experiments to drive scientific discovery.
• Ensure Data Quality: Maintain the accuracy and reproducibility of all research data.
• Stay Informed: Keep up with the latest advancements and technologies in biotechnology.
• Present Findings: Share research outcomes both with internal leadership and scientific teams and at scientific conferences and in publications.
• Manage Resources: Oversee research budgets and allocate resources effectively.
• Ensure Compliance: Adhere to all safety regulations and ethical guidelines.
• Collaborate Across Departments: Work with business development, manufacturing, and regulatory affairs teams. Coordinate with CMC, nonclinical development, early clinical development, finance and project management teams
• Protect IP: Contribute to the development of intellectual property and patent applications.

You have the following skills and qualifications:

• PhD degree in Biological Sciences, Bioengineering, Chemistry or a similar scientific discipline;
• 10+ years of drug discovery and development experience in the life sciences industry
• Experience with peptide drugs, peptide chemistry and associated early development activities
• Proven track record of advancing preclinical assets into early clinical development
• Experience with preclinical oncology drug development including in vivo tumor models
• Excellent data analysis and data presentation skills
• Excellent communication skills; able to lead cross functional teams and effectively communicate to key stakeholders and senior leadership
• Proven ability to establish, maintain, and lead high performing teams
• Able to hold team members and vendors accountable to execute on time and within budget
• Highly organized and process driven
• Ability to operate in a fast-paced, multi-disciplinary biotech environment
• Personal qualities of integrity, credibility, and unwavering commitment to company’s values and mission
• Management skills with a player-coach mentality to create and promote a positive and supportive cross functional work environment within the department and for team members at all levels throughout the organization
• Keen analytical and problem-solving skills
• Curiosity and growth mindset