Clinical Development Strategist

4 weeks ago

California, United States Aura BioSearch Full time
Job Title: Vice President Clinical Development

Aura Biosearch is conducting an executive search on behalf of our client, a global leader in the biopharmaceutical industry focused on rare diseases.

Our client is committed to making a significant impact on the lives of individuals living with rare conditions. Their success is driven by a passionate team that meets the unique needs of rare disease patients, making the work both professionally and personally rewarding.

They are currently seeking highly skilled individuals who thrive in a dynamic, fast-paced, and collaborative environment to join their team in advancing life-changing therapies for rare diseases. The ideal candidate will share their mission and values, which are centered on patient focus and collaboration, as they pursue their vision of bettering patients' lives worldwide.

Job Summary:

Our client is searching for a Vice President of Clinical Development to serve as a key strategic partner to the Chief Medical Officer (CMO). This role will oversee the strategic planning and execution of the metabolic and nephrology programs while leading cross-functional Project Strategy Teams composed of Clinical Development Operations, Regulatory, CMC, Medical Affairs, Commercial, and Project Management.

The VP will be responsible for developing and implementing the global strategy for clinical development and commercialization of programs in the client's pipeline, including potential new programs. The ideal candidate should bring significant expertise in clinical development, particularly in nephrology and rare diseases, and have experience managing the full lifecycle of therapeutics from pre-IND to commercialization across multiple modalities.

Key Responsibilities:
  • Provide clinical leadership and strategic direction across all programs.
  • Lead the development of global strategic plans for clinical development towards successful commercialization.
  • Provide deep knowledge in core disease areas and strategic insights into future development, publications, and presentations.
  • Offer oversight and facilitate discussions on development strategies and risks.
  • Cross-functional communication, including with the board, regarding program strategies, risks, and progress.
  • Lead regulatory strategy and FDA engagement, including regular presentations to regulatory agencies.
  • Manage and mentor teams, ensuring alignment with strategic goals and timelines.
  • Collaborate with key departments, including biometrics, regulatory, clinical operations, and medical affairs, to ensure cohesive program execution.
  • Develop and manage program budgets, timelines, and deliverables, ensuring strategic alignment and financial oversight.
  • Represent clinical development programs at scientific conferences and in discussions with regulatory agencies and Key Opinion Leaders (KOLs).
Requirements:
  • MD (nephrologist preferred) with 12 years of experience in pharmaceutical or biotechnology clinical development, including at least 6 years in a leadership role.
  • Extensive experience in clinical development across all phases from preclinical through commercialization, including successful NDA/BLA submissions.
  • Strong leadership, negotiation, and communication skills, with experience engaging various stakeholders.
  • Proven ability to lead cross-functional teams in a global environment, including experience with FDA and international regulatory bodies.
  • Willingness to travel domestically and internationally as necessary.

This is an exceptional opportunity to make a tangible impact in the rare disease space with an innovative and mission-driven biopharmaceutical company. If you possess the qualifications and passion for rare disease therapeutics, Aura Biosearch invites you to apply for this key leadership position on behalf of our client.

Remote Work: No

  • Customer Success Strategist

    4 weeks ago

    California, United States Intaso Full time

    Intaso is seeking a seasoned Customer Success Strategist to drive the transformation of a Customer Support function into a best-in-class Customer Success function.Key responsibilities include:Developing and executing a customer success strategy aligned with the company's growth objectives.Building and leading a high-performing customer success...

  • Strategic Director of Community Engagement

    3 weeks ago

    California, Missouri, United States EPIP Full time

    Strategic Director of Community EngagementThe Strategic Director of Community Engagement reports to the Chief Strategist, Programs. This position works closely with the Programs Team and Foundation staff to shape and implement the strategic vision for the Women's Foundation California, ensuring that the Foundation's programs are innovative and strategic and...

  • Growth and Marketing Strategist

    4 weeks ago

    California, United States Transitions Elite Full time

    About UsAt Transitions Elite, we're a dynamic team of innovators who are redefining the limits of what's possible. We're a positive cooperative team that prides itself on innovation, service, and adopting high-performing frameworks. Our mindset is focused on pursuing breakthroughs with the speed and precision of an Olympic sprinter and the strategy of SEAL...

  • Clinical Trial Coordinator

    4 weeks ago

    California, United States Bayside Solutions Full time

    Clinical Trial Assistant RoleBayside Solutions, Inc. is seeking a skilled Clinical Trial Assistant to join our team.Job Summary:The Clinical Trial Assistant will be responsible for supporting the clinical execution and management of clinical trials.Key Responsibilities:Assist with the coordination of clinical trials, including data management and...

  • Clinical Psychologist

    4 weeks ago

    California, United States AdeIphi MedicaI Staffing Full time

    Job SummaryAdeIphi MedicaI Staffing is seeking a highly skilled Clinical Psychologist to join our team at a correctional facility. As a Clinical Psychologist, you will be responsible for providing psychological services to mentally ill inmates, including conducting initial mental health evaluations, performing clinically sound suicide risk evaluations, and...

  • Editorial Director

    3 weeks ago

    California, Missouri, United States PlanetHome Full time

    About Planet Home:Planet Home is an environmental solution-focused platform that brings together thinkers and change-makers to address the world's greatest challenges.We create, discover, and celebrate world-changing ideas and innovations that address major issues faced by our ecosystem: climate, water, energy, waste, and biodiversity.Our goal is to connect...

  • Clinical Psychologist

    4 weeks ago

    California, United States AdeIphi MedicaI Staffing Full time

    Job SummaryAdeIphi MedicaI Staffing is seeking a highly skilled Clinical Psychologist to provide psychological services to mentally ill inmates/wards in a correctional facility. The ideal candidate will have a strong background in clinical psychology and experience working with vulnerable populations.Key ResponsibilitiesConduct initial mental health...

  • Associate Media Director

    1 week ago

    California, United States Mindgruve Full time

    We are a global digital agency comprised of strategists, creatives, media experts, data scientists, and engineers driven by one common purpose accelerate business growth through marketing and digital transformation. Named a top 3% Google Premier Partner and recognized by Inc. 5000 and Adweeks 75 Fastest Growing Companies, were constantly looking for A...

  • Associate Media Director

    1 week ago

    California, United States Mindgruve Full time

    We are a global digital agency comprised of strategists, creatives, media experts, data scientists, and engineers driven by one common purpose accelerate business growth through marketing and digital transformation. Named a top 3% Google Premier Partner and recognized by Inc. 5000 and Adweeks 75 Fastest Growing Companies, were constantly looking for A...

  • Associate Media Director

    2 weeks ago

    California, United States Mindgruve Full time

    We are a global digital agency comprised of strategists, creatives, media experts, data scientists, and engineers driven by one common purpose — accelerate business growth through marketing and digital transformation. Named a top 3% Google Premier Partner and recognized by Inc. 5000 and Adweek’s 75 Fastest Growing Companies, we’re constantly looking...

  • Associate Media Director

    1 week ago

    California, United States Mindgruve Full time

    We are a global digital agency comprised of strategists, creatives, media experts, data scientists, and engineers driven by one common purpose — accelerate business growth through marketing and digital transformation. Named a top 3% Google Premier Partner and recognized by Inc. 5000 and Adweek’s 75 Fastest Growing Companies, we’re constantly looking...

  • Nursing Professional Development Practitioner

    2 months ago

    Fresno, California, United States Saint Agnes Medical Center Careers Full time

    *Employment Type:* Part time *Shift:* Day Shift *Description:* Reporting to the Manager Clinical Education, Development & Support Services, the Nursing Professional Development Practitioner (NPDP)s practice is to support the provision of quality health care practice environments in alignment with the ANA Scope of Practice for Nursing Professional Development...

  • Associate Media Director

    2 weeks ago

    California, United States Mindgruve Full time

    We are a global digital agency comprised of strategists, creatives, media experts, data scientists, and engineers driven by one common purpose — accelerate business growth through marketing and digital transformation. Named a top 3% Google Premier Partner and recognized by Inc. 5000 and Adweek’s 75 Fastest Growing Companies, we’re constantly looking...

  • Amazon Account Strategist

    3 weeks ago

    California City, United States Dreamhire LLC Full time

    This role focuses on client satisfaction and client retention to build loyalty, while overseeing operations. Day to Day Duties: Build and maintain long-term relationships with clients. Oversee client milestone - Monitor the 30,60,90 day progress of the client Milestone - Milestone Operations - Brand Management Verify pain points are resolved, discover...

  • Amazon Account Strategist

    1 hour ago

    California City, United States Dreamhire LLC Full time

    This role focuses on client satisfaction and client retention to build loyalty, while overseeing operations. Day to Day Duties: Build and maintain long-term relationships with clients. Oversee client milestone - Monitor the 30,60,90 day progress of the client Milestone - Milestone Operations - Brand Management Verify pain points are resolved, discover...

  • Clinical Nurse Specialist

    6 months ago

    Oakland, California, California, 94617, Alameda County, CA, United States Alameda Health System Full time

    Summary Role Overview: Under general direction, to evaluate and diagnose the nursing problems of patients; to direct appropriate patient care treatment, counseling and education of patients and their families; to assist nursing staff in the evaluation of patients and the provisions of nursing care; to provide interprofessional consultation; and to...

  • Field Service Manager

    4 weeks ago

    california, United States Clinical Search Group, LLC Full time

    Job Title: Field Service ManagerHighlights:Fortune 500 Medical Device CompanyMarket Share Leaders - Innovators in their space.Career Growth OpportunitiesStrong Base Salary + Bonus + Company Vehicle + Medical/Dental etc.My client is seeking a highly skilled and experienced Service Manager. Specifically for their imaging/radiology division, this role is...

  • Clinical Educator II

    6 months ago

    Oakland, California, California, 94617, Alameda County, CA, United States Alameda Health System Full time

    Summary Alameda Health System offers outstanding benefits that include: 100% employer health plan for employees and their eligible dependents Unique benefit offerings that are partially or 100% employer paid Rich and varied retirement plans and the ability to participate in multiple plans. Generous paid time off plans This...

  • Clinical Social Worker, LCSW

    2 weeks ago

    California, United States Cedars Sinai Full time

    Job Description Align yourself with an organization with a reputation for excellence! Cedars-Sinai was awarded the National Research Corporation's Consumer Choice Award 19 times for providing the highest-quality medical care in Los Angeles. We were also awarded the Advisory Board Company's Workplace of the Year. Cedars-Sinai offers an outstanding benefits...

  • Clinical Nurse II

    2 weeks ago

    Oakland, California, California, 94602, Alameda County, CA, United States Alameda Health System Full time

    Summary SUMMARY: Under general supervision, provides nursing care to patients, including medications and treatment. Plans, implements, and evaluates patient care and performs related duties as required. The CN II level is the journey level class where incumbents have had the required professional nursing experience and are capable of independently...