Clinical Science Specialist
Role
Pellepharm seeks self – motivated and collaborative candidates for the Clinical Science Specialist Role. This position will report to the VP Clinical Development and is based in Pellepharm’s HQ in San Francisco.
Essential Duties
- Responsible for the implementation of clinical trial programs for assigned projects, and may serve as a medical monitor on some trials.
- Assists with the design, development, and writing of clinical protocols and other clinical trial documents. Authors ICFs.
- Conducts ongoing review of clinical data, including a medical review of patient profiles for safety and efficacy assessment, query generation and review of serious adverse events.
- Interacts with academic thought leaders to optimize clinical trial strategies and synthesizes the input into sound clinical trial designs.
- Develops scientific training materials and presentations for internal and external training to support clinical operations and development activities.
- Writes clinical science sections of Regulatory meeting packages and assists in the development and review of other clinical documentation required for regulatory submissions and other regulatory processes.
- Reviews and interprets the clinical safety and efficacy data for clinical accuracy.
- Collaborates with the clinical operations team to resolve data queries obtained from the clinical trials.
- Participates in the periodic review of safety information.
- Conducts a review of published literature or of clinical and preclinical reports in the field to provide the context for clinical development programs.
- Other projects as assigned by the Medical Director/Clinical Scientist
Personal Strengths
- Excellent organizational skills are essential
- Results- and goal-oriented
- Excellent interpersonal skills to be able to build strong internal and external relationships. Thrives in a team.
- Excellent written and verbal communication skills as well as the ability to present information to a wide range of groups/entities
- Meticulousness and attention to detail
- Ability to work with minimal supervision
- Hands-on and roll-up the sleeves attitude
Professional Requirements:
- Bachelor’s degree with 3+ years of relevant experience in the Pharmaceutical/Biotech Industry, including late-stage development.
- Graduates with nursing degrees and industry experience are encouraged to apply.
- M.D. without industry experience may be considered.
- Proven experience in data analysis, scientific writing/presentation of results in internal and external meetings, regulatory documents.
- Knowledge of Good Clinical Practices and pertinent adverse event reporting regulations.
Compensation
Other than working with a great team of smart, passionate and energetic people, Pellepharm also offers a competitive salary and benefits package that includes 100% coverage of health care premiums, life insurance, 401k, and perks.
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term career.
Pellepharm is an equal opportunity employer and values diversity. All employment is decided on the basis of qualifications, merit and business need.
The Company
PellePharm, Inc. is a privately held biopharmaceutical company based in the San Francisco Bay Area. Founded by world leaders in hedgehog signaling, PellePharm is committed to targeting rare genetic dermatological conditions, including Gorlin Syndrome and Basal Cell Carcinomas (BCCs), at the source. PellePharm is committed to improving the quality of life for those suffering from Gorlin Syndrome and BCCs by providing an easy-to-use topical gel that eliminates the need for regular, painful surgeries. The U.S. Food and Drug Administration awarded a Breakthrough Therapy Designation and Orphan Drug Designation to Patidegib after presenting positive Phase II data evaluating the safety and efficacy of the therapy in patients with Gorlin Syndrome. PellePharm is aiming to initiate the Phase III trials of the topical hedgehog inhibitor in 2019. PellePharm recently announced a partnership with Leo Pharma, a Danish pharmaceutical company, which enables the company to execute the Phase III studies and marks Leo Pharma’s entrance in rare skin disease.
IF YOU ARE INTERESTED IN THIS ROLE, PLEASE SEND YOUR CV TO CAREERS@PELLEPHARM.COM
