Senior Medical Director, Clinical Development

The posting, as Septerna wrote it

Septerna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients with the vision to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company. The company’s Native Complex Platform™ recapitulates GPCRs with their native structure, function, and dynamics outside of the cellular context. This approach enables novel access to modern structural and screening technologies used in industrial-scale drug discovery for the entire class of GPCRs. Septerna has an emerging pipeline of GPCR-targeted small molecule programs, many in the Endocrinology space, with potential for growth to target many GPCRs that have been undruggable and unexploited to date.

We are excited to expand our multidisciplinary team of individuals focused on creating revolutionary medicines to address the unmet needs of patients. At Septerna we strive to embrace diversity of thought, expertise, and background through collaboration. To join our ambitious team, be prepared to bring your real self to work every day; grow and learn from a talented team of drug hunters, scientists, and business professionals; and contribute your passion, creativity, and energy to accomplish our mission. We share a fearless pursuit of ground-breaking innovations and cultivate an environment where our employees succeed by learning from each other and working as a team.

We are committed to the development of meaningful therapeutics for patients with indications of high unmet need. This is a tremendous opportunity to work with talented individuals on the frontlines of therapeutic discovery and development. You will directly help move therapies through preclinical research, positioning them for success in the clinic. The successful candidate will add their passion, unique talents, and expertise to a dynamic team motivated to discover new disease-modifying therapeutics for patients in a fast-paced environment.

For more information see: www.septerna.com .

About The Role

Septerna has an exciting new opportunity to join the team as a Medical Director/ Senior Medical Director, who will provide strategic leadership clinical development strategy, planning, and tactical implementation for all clinical development functions. This position will also serve as the Clinical Development leader for one of Septerna’s clinical stage programs. This person is responsible for the design and successful cross-functional implementation of the clinical development plan (CDP). S/he will also participate in regulatory interactions and contribute to building relationships with KOLs. Ability to bridge clinical, scientific, and business needs with the aptitude to translate and align business and scientific goals and objectives. Must be a dynamic leader with outstanding strategic, communication, and collaboration skills.

Responsibilities

• Enterprise leader of program strategy, collaborating in a matrixed working environment with cli

[…]
ams.

• Outstanding management skills a must, both with respect to managing the development team but also evidence of successful enterprise/matrix leadership.
• Demonstrated ability to lead cross-functional teams to make significant recommendations and persuasively present synthesis of team diligence to gain alignment with senior management.
• Expertise in innovative clinical trial design, scientific writing, and the successful implementation of clinical protocols and clinical study reports.
• Experience in all phases of regulatory submissions and interactions; international experience also required, along with negotiation experience with the FDA.
• Comprehensive knowledge of Good Clinical Practices (GCP), ICH, ICJME Guidelines, FDA and other international regulatory body requirements.
• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency.
• Superb presentation skills.
• Thrives in a highly entrepreneurial biotech environment.

The anticipated salary range for candidates who will work in South San Francisco, CA is $340,000 - $380,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location and relevant education or training. Septerna's compensation package also includes benefits, stock options, and annual target bonus for full-time positions.

Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited. We are an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Septerna participates in the E-Verify program. California Consumer Privacy Act Privacy Notice For Job Applicants. If you are a California resident, click here for our CCPA Notice.