Why Work for Us

Are you ready to use your experience and expertise to make an impact on patients' lives? Astellas Gene Therapies is a biotechnology company developing new genetic medicines for rare, life-threatening diseases. We are working urgently to progress our medicines and need additional team members to help us do so. Because our mission is so important, our values are to: Be BOLD: Find a Way, Care Deeply, and Get Stuff Done. If you'd like to be a part of this important mission, please apply to join our team.

About Astellas Gene Therapies

Astellas Gene Therapies is developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Gene Therapy Center of Excellence (GT CoE) for their newly created genetic regulation focus area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. For more information, please visit our website: www.audentestx.com

Our Values:

• Be BOLD (Find a Way)

• Care Deeply -- for our patients, each other and our work

• #GSD (Get Stuff Done)

What is the catalyst for you in your professional career? Are you ready to be a part of a bold, innovative company, to make a change and to make a difference? Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us and be a part of our journey.

The Role

The Medical Director, Clinical Development provides medical monitoring for one or more gene therapy programs. The Medical Director leads design, implementation, monitoring, analysis, and reporting of clinical studies conducted within one or more programs. In addition, collaboration with other team members and functions to develop long-range strategic plans for the programs and execute upon these plans. The current focus of drug development at Astellas Gene Therapies is in the development and commercialization of highly innovative gene therapy technology in diseases where there is unmet medical need and for children and adults with serious, rare genetic diseases. Importantly, the needs of the patient and family are uppermost in our minds as we progress our programs, and this philosophy is one that needs to be embodied in all colleagues at Astellas Gene Therapies and in particular by the physicians.

Primary Responsibilities

• Participate in activities related to phase 1-4 clinical trials (e.g., develop protocols, investigator brochures, and clinical study reports and review clinical trial documents, CRO management, clinical support of regulatory interaction, and study analysis and reporting). Partner with Research, Regulatory Affairs, Non-Clinical Science, and Medical Affairs to ensure timely and effective clinical and scientific input into overall program. Participate in investigator meetings and lead site initiation visits with clinical trial investigators, and partner with Clinical Operations and Medical Affairs in driving enrollment into the clinical studies Represent the company at scientific meetings, patient advocacy events and presentations, as well as other public relations opportunities, as directed by the M&D leadership.

• Study Data Review and Analysis

• Provide clinical input into statistical planning and lead data analysis and interpretation

• Perform ongoing review and analysis of study data

• Provide medical leadership as needed for scientific issues that may arise during clinical trial execution

• Provide medical leadership and support for publication of data (manuscripts, posters, etc.) and disease or technology related scientific publications

• Lead efforts to develop strategic partnerships with Key Opinion Leaders

• Define, plan and provide Medical Monitoring to clinical development studies

• Review adverse events, monitor safety and prepare analysis and regulatory submission.

• Conduct thorough medical review of individual case safety reports

Required Education, Skills and Experience

• Medical Degree (MD); board certification in relevant specialty such as Pediatrics, Genetics, Internal Medicine, Metabolic Diseases or Neurology

• Proven clinical development experience designing, implementing and conducting clinical trials, with emphasis on proof-of-concept and first-in-human studies

• Strong computer skills including MS Office Suite (Word, Excel, PowerPoint, Outlook, MS Project) and in the use of industry-standard software and proficient in data analysis software (Excel, etc.) and data presentation

• A history of strong collaboration and personal interaction with all levels of internal stakeholders including, Regulatory Affairs, Medical Affairs, Clinical Operations, Biometrics, Research, Preclinical Science and Product Development

• Demonstrated success working with and influencing key external stakeholders (KOLs, investigators, researchers) including presenting/responding to the FDA and other regulatory authorities

• Outstanding leadership skills, comfortable, and indeed thrive in a flexible, dynamically changing and challenging environment

• Excellent strategic planning, organizational and communication skills

• Highest level of scientific integrity

• Expertise and consistent success in scientific research and/or clinical practice (as evidenced by appropriate higher qualifications, publication and/or relevant specialist accreditation)

• Willingness to travel 25-40%, with international travel at times

• Models our Core Values: Be Bold: Find a Way, Care Deeply, Get Stuff Done -- is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted

Preferred Skills and Experience

• Board certification in a relevant specialty such as Pediatrics, Internal Medicine, Metabolic Diseases, Genetics or Neurology

• Prior biotechnology/pharmaceutical experience leading clinical drug development (early-stage development through approval,) including developing clinical protocols, study design and successful regulatory approval (INDs, BLAs, NDAs) with US and international regulatory agencies

• Understanding of global pharmacovigilance regulatory requirements and guidance documents and proven ability to influence decision making around multifaceted issues involving medical safety

• Prior management experience, successfully managing other development/clinical research professionals

• Rare disease experience

• Gene therapy experience

Benefits:

• Medical, Dental and Vision Insurance

• Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down

• 401(k) match and annual company contribution

• Company paid life insurance

• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions

• Long Term Incentive Plan for eligible positions

• Referral bonus program

#LI-SS

Category AGT

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans