Director, Medical Affairs

The company Inc. is a biotechnology company advancing precision medicines for a broad range of genetic disorders. Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery. We focus on delivering life-changing advances for individuals with genetic disorders not addressable with current approaches. For more information, please visit [link for members] .

The company is seeking a Director, Medical Affairs that will serve to provide Medical Affairs support for early-stage gene therapy candidates. Reporting to the VP Clinical/Medical Affairs, the Director of Medical Affairs will serve as the primary Medical Affairs lead for the company's program for chronic pain and early pipeline programs. This is a highly visible internal and externally facing position, with responsibility for external communication and engagement, as well as other strategic initiatives to ensure appropriate and aligned clinical insights, communication, data dissemination and education with medical healthcare professionals. This role requires a versatile emerging leader with a strong scientific background and experience with early-stage clinical programs who seamlessly bridges cross-functional partnership across clinical development, evidence generation, scientific communication, and patient advocacy with direct, hands-on execution to advance first-in-human studies.

Responsibilities

• Define and implement a strategic plan for the company’s ETX301 clinical development program for pain in close collaboration with Scientific Communications, Clinical Development and the wider Medical Office.

• Collaborate closely with the Patient Advocacy team to ensure strategic and empathetic engagement that represents best practices for research and development, clinical trials, and pre-commercialization stage products.

• Build trusted professional relationships with the Key Opinion Leader community to exchange scientific knowledge and increase program awareness and understanding to support clinical trial design and enrollment.

• Partner with key functions such as Commercial, Strategy, Pre-clinical/Translational, Clinical Development/Operations, and Regulatory to determine scientific and clinical development strategies that support company objectives; support planning, execution and management of clinical trial activities and commercialization.

• Remain on the forefront of the relevant science and competitive landscape. Provide clinical and competitive insights from conference attendance and medical engagements.

• Collaborate closely with Clinical Development and Evidence Generation teams to develop and manage activities that support clinical development and regulatory approval, including Investigator Sponsored Studies, observational studies, and other research that supports endpoint development or validation.

• Collaborate cross-functionally, including with Corporate Communications and Scientific Communications, to develop key messages on disease state, MOA, target product profile, etc, and to develop communications plans for future and current clinical trials. Directly prepare or review scientific communications materials, as necessary.

• Define and manage long-range budget forecasts; identify, recruit, and manage flexible vendors to support and prioritize timely delivery of high-quality materials in a dynamic environment.

• Develop and implement methods and procedures for developing scientific presentations to individuals and groups of strategic importance to the company. Represent the company as an organization, and present data at advisory boards, clinical investigator meetings, congresses, etc.

Requirements

• MD, PhD, or MD/PhD in a relevant scientific or clinical discipline. For MD/MD-PhD: minimum of 4-6+ years of pharmaceutical/biotech industry experience in Medical Affairs, Clinical Development, or Medical Strategy. For a PhD: minimum of 5–8+ years of pharmaceutical/biotech industry experience with progressive leadership in Medical Affairs (MSL, Scientific Communications, Medical Strategy).

• A minimum of 2–3 years specifically supporting clinical development of Phase 1–3 programs.

• Proven ability to develop internal relationships in a highly matrixed environment, as well as external relationships with Key Opinion Leaders and industry experts.

• Prior experience and expertise in neuroscience and/or advanced therapy medicinal products (ATMPs).

• Ability to lead by example, build interdependent partnerships, and create a culture of collaboration and teamwork that fosters open communication, constructive conflict resolution and organizational flexibility.

• Proven success in prioritization and management of several complex, concurrent projects with tight deadlines, simultaneously.

• Excellent written and verbal communication and high-level negotiation skills; strong presentation skills are important.

• Excellent written, verbal, and interpersonal skills, and the ability to communicate at all levels within the company.

• Ability to communicate effectively at all levels and present complex and/or new ideas with clarity and simplicity. Strong analytical skills, especially with regards to understanding and interpreting scientific and clinical research and literature are essential.

• Demonstrated self-starter, team player, and do-er with strong interpersonal skills.

• Adept, nimble, energetic and comfortable in a fast-paced, dynamic and collaborative environment.

• An understanding of government and industry guidelines, regulations, laws, etc., for appropriate scientific/medical exchange and communication.

• Travel up to 40%, including internationally, may be required to represent the company at medical conferences, presentations, and other meetings.

• Support other duties as assigned

Preferred Qualifications

• Gene therapy experience

• Neurologic disease experience: particularly pain programs or epilepsy

• Experience across both pre-clinical/clinical stage as well as commercial stage companies

For candidates based in the San Francisco Bay Area without a medical degree (MD), the salary range for this position is 240,000 - 280,000

For candidates based in the San Francisco Bay Area with a medical degree (MD), the salary range for this position is 265,000 - 310,000

For remote candidates residing in the USA, without a medical degree (MD), the salary range for this position is 225,000 - 260,000

For remote candidates residing in the USA, with a medical degree (MD), the salary range for this position is 265,000 - 310,000

The company considers a variety of factors when determining base compensation, including experience, qualifications, internal equity and geographic location. Actual compensation will be determined based on relevant skills, experience, qualifications, internal equity, and business needs. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package.

Benefits

• Comprehensive benefits package, including competitive employer premium contributions

• Meaningful stock option grants

• PTO, sick time and holiday pay

• Generous Parental Leave program

• Pre-tax medical and dependent care programs

• STD, LTD, Life and AD&D

• Professional development opportunities

• Team-building events

• Fully stocked micro - kitchen

• Fitness center at South San Francisco location

The company is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. The company is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at the company are based on business needs, job requirements and individual qualifications, without regard to race, religion or belief, color, national origin, gender, status as a protected veteran, status as an individual with a disability, or any other status protected by the laws or regulations in the location in which we operate. The company will not tolerate discrimination or harassment based on any of these characteristics. The company encourages applicants of all ages.

If you need assistance or an accommodation due to a disability, you may call us at +1 650-491-0272.