Associate Director, Clinical Scientist, Internal Medicine

We are seeking an Associate Director to join our Clinical Development team. The Associate Director Clinical Sciences leads in the development, evaluation, planning and execution of clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program.

The Associate Director leads in a matrix environment as part of a cross-functional team and may contribute to drug-candidate development projects through early and / or late phase development.

The Associate Director reports to the Internal Medicine Clinical Development Unit Lead of Clinical Scientists or Therapeutic area Lead Clinical Scientist and collaborates closely with Medical Director(s) to provide scientific expertise vital to design and deliver on clinical studies and programs.

Candidates should take the time to read all the elements of this job advert carefully Please make your application promptly.

As an Associate Director, a typical day may include the following :

• May function as lead Clinical Scientist for program, and / or as delegate of Therapeutic area Lead Clinical Scientist; Member of the Clinical Study Team and Global Clinical Sub Team
• Contributes to program team meetings, scientific advisory boards, study steering committees and data / safety monitoring meetings;

may represent function in collaborative activities with other departments

• Maintains proficient understanding of therapeutic disease area(s) and drug candidate including underlying disease biology, clinical manifestations and therapeutic standard practice, compound(s) including mechanism of action and drug landscape
• Utilizes proficient scientific expertise to propose, design, and execute clinical research and development studies for early and / or late-stage assets;

able to conceive and communicate strategy proposals well-grounded in supporting literature

Authors and / or reviews documents related to trials, such as medical monitoring plans, SAPs, informed consents and clinical components of the Clinical Study Reports with minimal guidance and supports the development of regulatory documents;

performs quality review and / or approval; adjudicates and resolves cross functional comments with minimal support

Leads planning and prepares information for external / stakeholder meetings (IM, Governance, DMCs, Regulatory Authority);

Presents data and information to external investigators (SIV) and internal collaborators

Performs clinical / medical data review, including safety monitoring and activities and procedures that ensure patient safety;

Maintains compliance in accordance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety

Promotes consistent first line medical / clinical data review techniques and conventions across studies / programs; Reviews clinical data review plan and authors medical monitoring plan for assigned studies / program

This role may be for you if :

Exhibit confidence and professional diplomacy, while effectively relating to people at all levels internally and externally;

Demonstrated ability to Influence within team and department and may influence across functionally

• Demonstrate initiative, creativity and innovation skills. Directly contributes to the development of innovations. Identifies opportunities to initiate operational changes
• Strong cross-functional management, interpersonal and problem-solving skills
• Considerable organizational awareness, including significant experience working cross-functionally

To be considered for this role, you must have a Bachelor’s Degree, Advanced degree, or equivalent education / degree in life science / healthcare preferred (PhD / MD / PharmD / MSc).

Additionally, we need 8 years of pharmaceutical clinical drug development experience. Experience in managing cardiovascular and / or metabolic clinical trials is preferred.

Proven knowledge of the drug development process, Good Clinical Practice, study design, clinical research methodology & medical writing skills.

We are seeking proficient knowledge of clinical development process, regulatory requirements and ICH / GCP guidelines.

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