Sr. Director, Pharmaceutical R&D and Scientific Affairs

Nature and Scope

The Sr. Director, Pharmaceutical R&D and Scientific Affairs will be responsible for providing strategic leadership and oversight for the pharmaceutical research and development (R&D) functions across all sites. This role will drive innovation, ensure compliance, and optimize resource allocation to advance the development of new pharmaceutical products. The incumbent will be actively involved in identifying new product candidates for development and will take the ownership of planning and directing product development activities of selected compounds from project initiation through development, filing, approval and launch. The role will require multi-disciplinary activity and ability to build cross-functional collaboration with leaders from different departments and bring actionable leadership to the Scientific Affairs Organization.

Essential Duties and Responsibilities

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

Strategic Leadership:

• Develop and implement the long-term R&D strategy, aligning with the overall corporate objectives.
• Foster a culture of innovation and excellence within the R&D organization.
• Identify and evaluate emerging trends and technologies to drive competitive advantage.
• As a senior leader of Scientific Affairs Team, contribute to the strategic planning process and function as the collective voice of R&D and Regulatory Affairs, working with other members of Development, Medical & Commercial (DMC) management team to develop a robust pipeline of products along with a strong regulatory strategy and commercially viable launch strategy for company’s future growth.

R&D Portfolio Management:

• Prioritize and manage a diverse R&D portfolio, balancing risk and return.
• Collaborate with cross-functional teams to ensure efficient and effective project execution.
• Monitor project progress and make informed decisions regarding resource allocation and investment.
•  Serve as the Scientific Thought Leader in Portfolio Management Committee meetings and provide scientific and technical leadership for the development of New Drug Applications (NDAs), 505 (B) (2)s, Abbreviated New Drug Applications (ANDAs) and New Animal Drug Applications (NADAs).

Regulatory Compliance:

• Ensure adherence to all relevant regulatory requirements, including FDA, EMA, and other global health authorities.
• Partner with Regulatory Head to oversee the preparation and submission of regulatory documents. In collaboration with Regulatory counterpart, provide high-level oversight of the preparation and submission of New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), Investigational Drug (INDs) Applications, amendments, supplements, meeting requests, briefing packages, and other regulatory submissions in eCTD format in accordance with ICH, CFR and current Regulatory Guidance for FDA submissions.
• Lead Scientific & Regulatory Due Diligence activities for any incoming BD opportunities.

Talent Management:

• Recruit, mentor and lead a high-performance team to develop complex generic, First to File (FTF) and First to Launch (FTL) parenteral products. Establish organizational infrastructure, processes and methodologies to drive efficiencies and innovation and achieve superior performance with a commitment to continuous improvement.

• Develop robust Career Development Plan for everyone in the Department and identify and nurture next generation of leaders through continuous mentoring and feedback.

Resource Management:

• Optimize resource allocation to maximize efficiency and productivity.
• Develop and manage R&D budgets. Negotiate contracts with external vendors and service providers.

•  Embrace the Quality culture and demonstrate Core Competencies. Develop and improve procedures to   ensure compliance for cGMP testing methods and equipment.

• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• Ph. D. in life sciences with concentration in Chemistry or Pharmaceutical Science, required with a proven track record of complex product development and NDA approvals.
• Minimum 15 years relevant industry experience in formulation, analytical and process development with complex molecules encompassing solutions, lyophilized and/or suspension dosage forms and novel drug delivery platforms, required.
• Minimum of 7 years of people management experience, required.
• Minimum 5 years demonstrated senior leadership experience with a proven track record of successfully leading drug development programs.
• Deep understanding of drug discovery, development and regulatory processes.
• Experience in a start-up biotech experience, familiarity with advanced technologies, and platforms in drug development with a track record of successful product launches is a huge plus.
• Excellent organizational leadership and interpersonal skills.
• Strong communication skills and technical writing skills.
• Working knowledge of regulatory process and requirements.
• Responsibilities include domestic and international travel, 25%.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

Applicants have rights under Federal Employment Laws.

• FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
• Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

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