Über diese Senior Medical Director, Clinical Development Stelle bei Septerna
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 clinical operations, regulatory, clinical pharmacology, research, CMC, and other functions to ensure the success of drug development programs.
- Work with key internal and external stakeholders to lead the design and implementation of robust CDPs to achieve the desired target product profile.
- Guide the development team(s) with aggressive, creative, but realistic approaches to drug development.
- Direct and design fit-for-purpose clinical trials across all phases in drug development; design and draft protocol synopses, clinical trial protocols, amendments, and supporting documents.
- Contribute to IBs, regulatory documents, CSRs, and publications associated with clinical trials.
- Provide medical oversight of multiple clinical studies and provide medical input and guidance on scientific, clinical and safety monitoring issues.
- Be accountable via collaboration across functions and clinical operations for all relevant timelines and deliverables.
- Collaborate with regulatory affairs to develop high-quality strategic regulatory strategies and engagement.
- Communicate to management and relevant functions any potentially significant issues to the CDP or emerging safety risks in a timely manner.
- Provide strategic consultation and guidance to Research on decision that have significant clinical components and implications.
- Ensure compliance with SOPs, ICH, GCP, and other national and international regulatory requirements.
- In conjunction with the VP of Clinical Development, ensure organizational growth plans for clinical Development scales with Septerna’s current and future needs.
- Mentor and develop more junior physicians and other clinical development staff to successfully advance to higher levels of responsibility.
- Travel to clinical sites, conferences, and regulatory meetings as needed.
Qualifications
- MD or MD/PhD required and 5+ years of experience in Clinical Development or related pharmaceutical capacity.
- Endocrinology/Board Certified Endocrinologist or extensive experience in endocrinology-related drug-development required.
- Rare disease experience is preferred.
- Excellent communicator with team building and collaboration skills.
- In depth knowledge of drug development process and oversight of clinical trials; well versed in first-in-human trials as well as late phase development and product filing/ registration.
- Has seen and managed significant accelerations and challenges in clinical programs.
- 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.
