Skip to content

Job Openings

Clinical Development Lead

Pleasanton, CA 94588

Posted: 06/28/2024 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 606140 Is job remote?: Yes Country: United States

Job Description


Target Pay Rate: 45.91-100/hr **salary will be commensurate with experience 

Basic Functions and General Scope:

The Clinical Development Lead, Infection and Immunity, provides clinical guidance for the development of new laboratory and digital diagnostic products in the areas of infectious diseases and immunology at client.The lead identifies unmet needs for new products, defines their clinical requirements, contributes to early research and development, and, as the clinical leader on cross-functional project teams, leads the clinical development and validation strategy to register these products as In Vitro Diagnostics with regulatory agencies.

This position may be based out of Pleasanton, California, USA, with remote work locations possible. The position will report to the Head of Clinical Development, Infection and Immunity, in the Clinical Development and Medical Affairs department. There will not be positions reporting administratively into this role, but the incumbent is expected to function as a leader of matrixed teams and to mentor and supervise the work of junior members of the department and to foster individual development throughout the organization.

Specific Responsibilities:
  • Serves as a medical leader and expert, keeping the company abreast of advances in clinical medicine, health systems and public health relating to infectious diseases and immunology, and connects the company to external experts and stakeholders.
  • Identifies areas of unmet medical need for diagnostics.
  • Leads exploratory studies to guide product development and generate intellectual property.
  • Defines potential clinical utility claims for products. Provides medical/scientific input into and assists with the preparation of regulatory submissions. Provides responses to regulatory agency questions.
  • Assists Research and Development Groups with target product profiles and design choices. and the design of performance verification and troubleshooting experiments. Reviews the data from these experiments from a clinical perspective.
  • Develops product specifications to ensure that products will be safe, effective and clinically useful.
  • Works with Clinical Operations to design, implement, interpret, report and publish clinical research studies to support product registrations. Identifies suitable academic partners, external laboratories and clinical sites to participate in clinical studies.
  • Presents research findings in meeting abstracts and publications.
  • Provides clinical expertise for medical risk and safety assessments.

Position Requirements:
  • Graduate work in microbiology, virology, or immunology; Completion of an MD and/or PhD preferred. 1+ years of clinical research experience, with thorough knowledge of clinical trial design and statistical methods for clinical research. More experience is preferred.
  • Proven ability to design clinical trials, critically evaluate study results, and write protocols, study reports and publications.
  • Understanding of laboratory techniques in infectious diseases in at least one of the following areas (more are preferred): PCR, sequencing, serology, microbiology, clinical virology.
  • Excellent organizational, communication, and project management skills.
  • Experience interfacing with key opinion leaders including physicians and clinical laboratorians.

Preferred:
  • 3+ years clinical experience in infectious diseases clinical care or in medical microbiology/virology. Board certification is a plus.
  • Laboratory work experience.
  • Expertise in epidemiology, biostatistics, implementation science or other aspects of public health.
  • Experience within the diagnostics, medical device or pharmaceutical industry, with an understanding of the product development process, regulatory processes, and a track record of regulatory approval based on clinical trials.
  • Experience with the development of clinical software.
  • Expertise in one or more of the following clinical areas: (a) immunocompromised host, HIV, transplant; (b) sepsis; (c) hepatitis; (d) respiratory infections; (e) clinical immunology.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

Apply Online

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.

About Pleasanton, CA

Ready to embark on a fulfilling career journey in the vibrant region of Pleasanton, California? This picturesque city nestled in Alameda County offers a unique blend of suburban charm and exceptional growth opportunities for job seekers. Known for its charming downtown area with historic buildings, Pleasanton boasts a thriving arts scene with galleries like Firehouse Arts Center and Bankhead Theater. Indulge in the region's diverse cuisine, explore the scenic trails of Shadow Cliffs Regional Recreation Area, and catch a game of the Oakland Athletics at the nearby RingCentral Coliseum. Embrace the enchanting culture and endless possibilities that Pleasanton has to offer as you explore our curated job listings to find your perfect match. Let's kickstart your career journey in Pleasanton, CA today!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.