This is a full-time role requiring presence in the South San Francisco, CA office at least 1-2 days per week, with the flexibility to work from home part-time. The Associate Director, Translational Science will report to the VP of Translational Science and work closely with members of the translational, research and clinical teams. The role has an individual contribution focus on the translational medicine work in the ongoing clinical development of leading drug candidates for the company. The central responsibilities for the role are in assisting the development and implementation of a translational medicine strategy for PK, PD, biomarker and immunogenicity assessments along with a key role in the subsequent data analysis and the writing of translational study reports in support of translational work for clinical studies.

As an Associate Director, the candidate is expected to represent translational sciences as a translational medicine lead for clinical studies and work closely with the clinical development team members including bioanalysis, clinical operations, regulatory affairs, quality, medical writing, safety, clinical research and clinical leadership. Knowledge of regulatory requirements for translational medicine research and experience in generating and guiding document preparation, analytical plans and contributions to the translational medicine components in clinical study protocols is required.

A current understanding of industry guidance for regulated bioanalysis in preclinical and clinical is needed. The role will require the candidate to work closely with clinical pharmacologist and clinical scientists to achieve key deliverables. Prior experience in documentation preparation (including clinical study memos, BLA or IND documents) for regulatory interactions with both the FDA and potentially global regulatory agencies is of high value to a candidate’s application. This role provides additional opportunities to participate in a preclinical team environment as a contributor towards IND enabling translational research studies, particularly in cynomolgus studies for PK/PD, dose range finding and GLP tox studies.

Prior experience in working with toxicologist or outsourcing with toxicology consultants is beneficial, with experience in authoring internal reports and contributing to regulatory filings as value added. As part of the collaborative research team role, the candidate is expected to work with individuals across research and translational research groups, including discovery research, drug development and protein sciences, preclinical bioanalysis and other junior staff within translational research organization.

OUR CORE VALUES

The below core values drive all that we do here at Star. We are looking for like-minded individuals that feel passionately about these same values to join our team.

Patients are our Center of Gravity: We partner with patients in unique ways, to uncover and address their unmet needs.
Propelled by Data, Guided by Intuition, Informed by Expertise: We boldly explore new diseases, novel biology, and smart ways of working with a sense of urgency.
Mission Ready Crew: With courage and agility, we opportunistically challenge conventional wisdom and foster an environment of respect and continuous growth.

RESPONSIBILITIES

Primary interface and translational medicine lead in support for clinical teams for Phase 1 through Phase 3 clinical studies, and potentially during lifecycle management.
Oversee translational medicine strategy planning and implementation during clinical trials
Data analysis, data review, data interpretation and data delivery in support of regulatory filings within program timelines for translational datasets
Prepare translational medicine study reports for incorporation into clinical study reports and preparations for regulatory interactions and filings
Capture and communicate clinical development team needs to the translational research team in support for clinical programs
Provide expertise and guidance for translational medicine strategy with bioanalysis team
Work with clinical pharmacology to deliver PK reports and modeling as needed during clinical development

EDUCATION, EXPERIENCE & QUALIFICATIONS

Ph.D. and 8+ years of experience or Masters and 12+ years of experience required
Experience working on clinical teams in the development of drug candidates (early and/or late clinical studies are both of value)
Experience in project leadership and a track-record of authoring translational clinical study reports for clinical studies with particular focus on regulatory filings.
Experience in supporting regulatory interactions as a subject matter expert for Translational Medicine in collaboration with clinical and regulatory affairs team members
Candidates with extensive experience developing and managing relationships with toxicologist and clinical pharmacologist are encouraged to apply.
Strong scientific background in key disease areas or evidence of broad work in multiple disease areas displaying adaptability in learning new indications
Ability to interface in collaborative clinical development teams, including with key interactions with bioanalytical, clinical pharmacology and clinical sciences.
Strong technical and scientific writing skills to deliver key data summaries and documents
Ability to review and contributions to clinical study protocol development on behalf of translational medicine organization.
Familiar and adept in knowledge across a wide range of data workstreams for PK, PD, biomarker and immunogenicity assessments.
Biomarker and PK/PD data analytics with integrated data analysis
Technical document writing and review in creation of clinical study reports, SOPs, and regulated documents, with ability to work within GXP guidance
Preparation of slide presentations and documentation for regulatory agency interactions
Project management, including balancing competing timelines across multiple programs
Ability to work in a fast-paced environment requiring flexibility and clear communication

ABOUT STAR THERAPEUTICS

Star Therapeutics is a Phase 3 clinical stage biotechnology company that aims to discover and develop best-in-class antibody therapies to transform the lives of patients with serious diseases. Founded by former True North executives, Star has built a team with significant scientific, clinical, regulatory, and commercial experience that has a demonstrated track record of success and is backed by top-tier biotech investors. We pride ourselves on our collective passion in bringing innovative therapies to the clinic and are committed to patients for whom no or limited treatment options exist.

Star is headquartered in South San Francisco, CA. More information about Star can be found on our website at www.star-therapeutics.com.

Star offers a competitive salary and benefits package and we take pride on being a best place to work. We’re also a company where you can flourish and grow your career, learn and explore, and make connections.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender identity, sexual orientation, age, marital status, veteran status, or disability status.

We anticipate the base salary for the Associate Director, Translational Science position in our South San Francisco, CA office to range from $156,000 to $195,000 annually and will depend on current market data and the candidate’s qualifications for the role, including education, experience and geographic location. This position is also eligible for bonus, benefits, and participation in Company’s equity plan. The compensation described above is subject to change and could be higher or lower than the range described based on several factors.

Qualified candidates should apply via our careers page at: https://star-therapeutics.com/our-careers/

Please note: This is not a remote position. NO PHONE CALLS or AGENCIES, please.

Note to External Recruiters: Submission of unsolicited resumes prior to an agreement set in place does not create any implied obligation.

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