Internship International Medical Writer Jobs in San Ramon, CA

The Opportunity:

We are seeking an experienced clinical science drug developer to serve as Medical Director in support of Revolution Medicines' clinical-stage molecule(s). In this critical role, you will support various clinical science deliverables and enable effective and efficient execution of the clinical development plan for a molecule(s) within its particular indication(s).

The physician-scientist will focus on ensuring the accuracy, completeness, and integrity of clinical data supporting regulatory submissions (NDA, BLA, MAA). This role is uniquely positioned at the interface of clinical development, regulatory science, clinical data, and clinical operations, and will be instrumental in preparing pivotal datasets from the pivotal and supportive studies for successful global filings.

The ideal candidate brings a strong foundation in clinical medicine (M.D. or equivalent), oncology experience, and proven expertise in clinical trial data review, cleaning, and regulatory submission preparation. The scope of data review and support activities spans early-stage clinical research to pivotal studies including regulatory submissions. You will play a vital role in leading the clinical science aspects of the Clinical Development Plan (CDP) strategy, driving the development of transformative therapies for patients. Furthermore:

• Serve as the clinical point of accountability for data integrity in ongoing and completed studies across the oncology portfolio.

• Apply medical expertise to guide query resolution, adjudication of outliers, and clinical plausibility review during data cleaning.

• Collaborate with clinical study teams to align protocol design, CRFs, and data standards with downstream regulatory submission requirements.

• Lead clinical science aspects of the clinical development strategy and clinical documentation.

Represent the clinical development plan on appropriate teams, sub-teams and forums; oversee training of study site personnel, act as primary point-of-contact for questions/enquires regarding the CDP at a program level, oversee the conduct of medical/safety data reviews and study reporting.

• Partner with Regulatory Affairs, Biostatistics, Data Management, and Medical Writing to ensure clinical datasets, narratives, and summaries meet FDA, EMA, and ICH standards for NDA/BLA/MAA filings.

• Support the Medical Monitors Medical Lead and other team leads in clinical sections of regulatory dossiers, including Integrated Summary of Efficacy (ISE), Integrated Summary of Safety (ISS), and Clinical Study Reports (CSRs).

• Support in the preparation of responses to regulatory authorities and contribute to advisory committee briefing documents.

• Drive end-to-end data cleaning strategy, ensuring timely resolution of queries and reconciliation of safety, efficacy, and laboratory data.

• Lead clinical data review meetings, escalating issues and recommending solutions to maintain data reliability and consistency.

• Potential assignment to complex and high-priority strategic studies for Revolution Medicines' molecules, with expectation to perform responsibilities with independence and clear self-directed leadership.

• Work closely with Data Management, Medical Monitors, CRO, Clinical Operations to ensure that site-level data collection, query resolution and other activities align with submission requirements.

• Partner with RevMed's Pharmacovigilance to reconcile safety databases with clinical trial datasets.

• Cross-functionally align efforts seamlessly with scientific, regulatory, and commercial objects while executing upon the clinical development plan.

• Lead, mentor, and contribute to a high-performing cross-functional team of clinical development professionals, fostering a culture of collaboration, innovation, and excellence.

• Oversee all aspects of clinical trial design and execution, including site selection, patient recruitment, data management, and regulatory compliance.

• Establish and maintain strong relationships with clinical investigators, regulatory agencies, and key stakeholders.

• Gather, analyze and interpret clinical data, providing strategic insights to inform critical decisions and guide program development.

• Manage clinical development timelines effectively, ensuring efficient resource allocation and achievement of milestones.

• Stay abreast of the latest scientific advancements and regulatory trends in the field of clinical development.

Required Skills, Experience and Education:

• M.D. (or equivalent international medical degree, MBBS, MBChB,) with board certification/eligibility in Oncology; with subspecialty training in GI malignancies (strongly preferred).

• Minimum 5+ years' experience in clinical development required in solid tumors generally, and GI Tumors (strongly preferred) .Pharma R&D experience outside of a clinical development role also considered pending transferability of skills and responsibilities within the biotech/pharmaceutical industry.

• Demonstrated experience with medical data review, cleaning for NDA or BLA filings and regulatory submissions.

• Strong working knowledge of data cleaning, database lock processes, and clinical data review.

• Proven ability to lead cross-functional clinical teams and contribute to strategic development plans.

• Excellent written and verbal communication skills for both scientific and regulatory audiences.

• Extensive experience working with the principles and techniques of data analysis, interpretation, and clinical relevance as related to the pharmaceutical/biotech industry.

• Experience in independent generation of trial design, protocol writing/ICF (writing or amendment), constructing appropriate CRF and coordinating cross-functionally.

• In-depth therapeutic area experience/expertise, and relevant clinical trial experience (or clear ability to adapt with transferable skills).

• Strong knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMA and other relevant guidelines and regulations is required.

• Proven ability to work effectively and efficiently within cross-functional teams involved in the drug development process; proven ability to efficiently integrate multiple perspectives into the CDP.

• Experience authoring regulatory briefing packs, write responses to Health Authority questions, and proven ability to contribute to strategic approach and cross-functional coordination in support of regulatory activities/interactions.

• Demonstrated success in driving various aspects of cross-functional study level strategy, e.g. study design, supporting feasibility and timelines/budget projections, protocol amendment requirements. Ability to drive relevant discussion at key internal decision-making bodies/governance.

• Proven ability to build and maintain strong relationships and contribute to interactions with external key opinion leaders to optimize clinical programs (e.g. advisory boards, individual engagements, steering committees, etc.).

• Experience in (or clear ability) investigator engagement to optimize clinical trial conduct. Includes presenting at investigator meetings.

• Strong orientation to teamwork. Excellent leadership, communication, and interpersonal skills with the ability to inspire, motivate and mentor across a diverse team.

• Experience in mentoring other team members. Experience or clear potential as an effective line manager.

• Expertise in building and maintaining strong relationships with internal and external stakeholders.

• Superb strategic thinking and analytical skills, with the ability to make data-driven decisions in a fast-paced environment. Able to recognize trade-off decisions and can determine priorities and goals.

• Strong written and business presentation skills is required.

• Passion for innovation and a commitment to developing therapies that make a meaningful difference in patients' lives.

• Demonstrated strong leadership presence.

• Has demonstrated adaptability and flexibility.

• Anticipates needs, assesses and manages business and organizational risks.

• Ability to thrive in a fast-paced, collaborative biotech environment.

Preferred skills:

• Experience in ongoing enhancements/development of core and sub-team processes, structures, systems, tools and other resources in the pharmaceutical/biotech industry.

• Has led clinical development contributions to major regulatory submissions (e.g. (s)NDA, (s)BLA, PIP/PSP, label negotiation, Breakthrough Therapy Designation, Accelerated Review) is a major plus.

• Proven ability to present the clinical development aspects of a program(s) to key major reference health authorities (FDA, EMA, others.) by teleconference or in-person. Has led Health Authority interaction(s).

• Proven ability to set out the clinical development strategy for CTA/EC submissions and responses to health authority questions.

• Has demonstrated collaborate behaviors on enterprise-level strategic initiatives with a variety of internal and external partners and stakeholders - including clinical investigators/clinicians, scientists and key opinion leaders (KOLs), as well as internal groups, including other groups in development, research, business development, commercial, legal, etc. - resulting in demonstrable outcomes that have further enhanced strategic goals.

• Influential and inspiring leader, with proven ability to bring teams and individuals along with them.

• Has demonstrated courage and conviction in past positions and responsibilities. Demonstrated skills in conflict resolution.

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